265. Lipodystrophy Clinical trials / Disease details
Clinical trials : 112 / Drugs : 155 - (DrugBank : 55) / Drug target genes : 25 - Drug target pathways : 97
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05470504 (ClinicalTrials.gov) | January 23, 2023 | 16/7/2022 | Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance | Phase II Study of Growth Hormone Inhibition Using Pegvisomant In Severe Insulin Resistance | Insulin Receptor Mutation;Partial Lipodystrophy | Drug: Pegvisomant | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Recruiting | 18 Years | 65 Years | All | 25 | Phase 2 | United States |
| 2 | NCT05383456 (ClinicalTrials.gov) | April 18, 2022 | 8/4/2022 | The Visceral Adiposity Measurement and Observation Study | The Visceral Adiposity Measurement and Observation Study | HIV;HIV-Infections;HIV-1-infection;HIV I Infection;HIV Lipodystrophy;HIV Infection Primary;HIV-Associated Lipodystrophy;HIV Disease Progression;Lipohypertrophy;Liver Diseases;NAFLD;NASH;Liver Fibrosis;Hepatic Fibrosis;Waist Circumference;BMI;Ectopic Fat;Liver Fat;Hepatic Steatosis | Diagnostic Test: Diagnostic Test;Drug: HIV Anti-retroviral Background Therapy | Theratechnologies | Dacima Consulting;Medpace, Inc.;Vanderbilt University Medical Center;Echosens | Recruiting | 18 Years | N/A | All | 400 | United States | |
| 3 | NCT05088460 (ClinicalTrials.gov) | February 28, 2022 | 12/10/2021 | A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD) | A Randomized Double-Blind Placebo-Controlled Study of the LEPR Agonist Antibody REGN4461 for the Treatment of Metabolic Abnormalities in Patients With Familial Partial Lipodystrophy | Familial Partial Lipodystrophy;Metabolic Abnormalities | Drug: REGN4461;Drug: Matching Placebo | Regeneron Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 2 | United States;France;Spain;Turkey |
| 4 | NCT05164341 (ClinicalTrials.gov) | December 17, 2021 | 11/11/2021 | Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL | A 12-Month Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With Partial Lipodystrophy | Partial Lipodystrophy | Drug: metreleptin;Drug: Placebo | Amryt Pharma | NULL | Recruiting | 12 Years | N/A | All | 65 | Phase 3 | United States;Canada |
| 5 | NCT04710056 (ClinicalTrials.gov) | June 2021 | 13/1/2021 | Expanded Access to REGN4461 for Patients With 1) Generalized Lipodystrophy, 2) Partial Lipodystrophy or 3) Monogenic Obesity Due to LEP or LEPR Loss of Function | Generalized Lipodystrophy;Partial Lipodystrophy;Monogenic Obesity Due to LEP or LEPR Loss of Function | Drug: REGN4461 | Regeneron Pharmaceuticals | NULL | Available | NULL | ||||||
| 6 | NCT04860063 (ClinicalTrials.gov) | April 2021 | 17/4/2021 | Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH. | Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in People Living With HIV. | Metabolic Syndrome;HIV-1-infection;Glucose Intolerance;Dyslipidemias;Lipodystrophy;Lipoatrophy | Drug: Berberine;Drug: Placebo | Hospital Civil de Guadalajara | NULL | Not yet recruiting | 18 Years | 60 Years | All | 40 | Phase 3 | NULL |
| 7 | NCT04903847 (ClinicalTrials.gov) | February 2, 2021 | 9/10/2020 | Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil | Changes in Weight After Switch to Dolutegravir/Lamivudine or Doravirine/Tenofovir/Lamivudine Compared to Continued Treatment With Dolutegravir/Tenofovir/Lamivudine for Virologically Suppressed HIV Infection. AVERTAS-2 | Hiv;HIV Infections;HIV Lipodystrophy;Osteoporosis;Renal Insufficiency;Weight Gain;Obesity | Drug: Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO];Drug: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO] | Thomas Benfield | NULL | Recruiting | 18 Years | N/A | All | 126 | Phase 4 | Denmark |
| 8 | NCT04904406 (ClinicalTrials.gov) | October 22, 2020 | 9/10/2020 | Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals | Changes in Weight and Body Composition After Switch to Dolutegravir/Lamivudine Compared to Continued Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed HIV Infection: A Randomized Open-label Superiority Trial: AVERTAS-1 | Hiv;HIV Infections;HIV Cardiomyopathy;Weight Change, Body;HIV Lipodystrophy;Cardiovascular Diseases | Drug: Dolutegravir / Lamivudine Oral Tablet | Thomas Benfield | NULL | Recruiting | 18 Years | N/A | All | 95 | Phase 4 | Denmark |
| 9 | NCT04340388 (ClinicalTrials.gov) | September 17, 2020 | 1/4/2020 | Contribution of Dolutegravir to Obesity and Cardiovascular Disease | Contribution of the Integrase Inhibitor Dolutegravir to Obesity and Cardiovascular Disease in Persons Living With HIV | HIV-1-infection;Antiviral Drug Adverse Reaction;Vascular Diseases;Cardiovascular Abnormalities;Abnormality of Adipose Tissue;Body Weight Changes;Body Fat Disorder;HIV-Associated Lipodystrophy Syndrome | Drug: Dolutegravir 50 MG;Drug: Antiretroviral/Anti HIV | Augusta University | NULL | Recruiting | 18 Years | 100 Years | All | 30 | Phase 4 | United States |
| 10 | NCT03900286 (ClinicalTrials.gov) | January 16, 2020 | 26/3/2019 | Low Energy Diet and Familial Partial Lipodystrophy | Evaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and Diabetes | Lipodystrophy;Diabetes;Diet Modification | Dietary Supplement: Total Dietary Replacement | Cambridge University Hospitals NHS Foundation Trust | NULL | Recruiting | 18 Years | 99 Years | All | 20 | N/A | United Kingdom |
| 11 | NCT04159415 (ClinicalTrials.gov) | January 7, 2020 | 7/11/2019 | Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy | A Randomized, Double-Blind, Placebo-Controlled Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy | Generalized Lipodystrophy | Drug: Placebo;Drug: Low-Dose REGN4461;Drug: High-dose REGN4461 | Regeneron Pharmaceuticals | NULL | Active, not recruiting | 12 Years | N/A | All | 16 | Phase 2 | United States;Peru;Russian Federation;Turkey |
| 12 | NCT04056000 (ClinicalTrials.gov) | September 1, 2019 | 23/5/2019 | Lipodystrophy and Fat Metabolism During Exercise | The Regulation of Fat Metabolism in a Cyclist With Lipodystrophy: a Case Study | Healthy;Lipodystrophy, Familial Partial | Dietary Supplement: Caffeine;Dietary Supplement: High-carbohdyrate breakfast;Behavioral: 60-minutes of steady state exercise | University of Exeter | NULL | Withdrawn | 18 Years | 35 Years | Male | 0 | N/A | United Kingdom |
| 13 | NCT04026178 (ClinicalTrials.gov) | November 14, 2018 | 30/10/2018 | Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy | A 36-Month, Multicenter, Open Label Phase 4 Study to Evaluate the Immunogenicity of Daily SC Metreleptin Treatment in Patients With Generalized Lipodystrophy | Generalized Lipodystrophy | Drug: Metreleptin | Aegerion Pharmaceuticals, Inc. | NULL | Recruiting | 1 Year | N/A | All | 10 | Phase 4 | United States |
| 14 | EUCTR2017-003014-22-AT (EUCTR) | 25/06/2018 | 29/05/2018 | Leptin in hepatic lipid metabolism in humans | The role of leptin in regulating hepatic lipid metabolism in humans - Leptin and hepatic lipid metabolism | lipodystrophy patients, patients after liver transplantation and healthy controls;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Myalept Product Name: Myalept INN or Proposed INN: metrelpetin Other descriptive name: METRELEPTIN | Medical University of Vienna | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 43 | Phase 2 | Austria | ||
| 15 | NCT03514420 (ClinicalTrials.gov) | May 30, 2018 | 21/4/2018 | Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With With Familial Partial Lipodystrophy (FPL) | An Open-label Phase 2 Study of ISIS 703802 (AKCEA-ANGPTL3-LRx) Administered Subcutaneously to Subjects With Familial Partial Lipodystrophy | Familial Partial Lipodystrophy | Drug: AKCEA-ANGPTL3-LRX | Akcea Therapeutics | Ionis Pharmaceuticals, Inc. | Completed | 18 Years | N/A | All | 4 | Phase 2 | United States |
| 16 | NCT03508687 (ClinicalTrials.gov) | March 13, 2018 | 3/4/2018 | Study of Gemcabene in Adults With FPLD | An Investigator-Initiated Open-Label, Randomized Study of Gemcabene in Adults With Familial Partial Lipodystrophy Disease (FPLD) | Familial Partial Lipodystrophy;Hypertriglyceridemia;Fatty Liver;NASH - Nonalcoholic Steatohepatitis | Drug: 300mg Gemcabene;Drug: 600mg Gemcabene | Elif Oral | NULL | Completed | 18 Years | N/A | All | 5 | Phase 1/Phase 2 | United States |
| 17 | NCT03226821 (ClinicalTrials.gov) | February 7, 2018 | 20/7/2017 | Body Composition and Adipose Tissue in HIV | Body Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin Therapy | HIV Lipodystrophy Syndrome;Growth Hormone Deficiency;Body Composition | Drug: Tesamorelin | Columbia University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting | 18 Years | 68 Years | All | 24 | Phase 4 | United States |
| 18 | NCT03262610 (ClinicalTrials.gov) | February 17, 2017 | 22/8/2017 | Setemelanotide in a Single Patient With Partial Lipodystrophy | Expanded-access for the Use of Setemelanotide in a Single Patient With Partial Lipodystrophy (LD) Associated With Leptin Deficiency and Multiple Autoimmune Diseases | Hypertriglyceridemia | Drug: Setmelanotide | Rhythm Pharmaceuticals, Inc. | NULL | No longer available | 15 Years | 15 Years | Female | United States | ||
| 19 | EUCTR2015-004846-25-BE (EUCTR) | 15/07/2016 | 30/03/2016 | Anti-oxLDL IgM antibodies as a novel therapy for metabolic lipid diseases | Immunization against oxLDL in patients with lysosomal lipid diseases and associated metabolic disorders | Familial hypercholesterolemia Niemann-Pick disease type B (NPB)Niemann-Pick disease type C (NPC)Partial lipodystrophy in children and adults;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Prevenar13 Product Name: Prevenar13 | Maastricht University | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Belgium | |||
| 20 | NCT02430077 (ClinicalTrials.gov) | June 2016 | 24/4/2015 | Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients | Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients | Familial Partial Lipodystrophy | Drug: Obeticholic Acid;Drug: Placebo | University of Texas Southwestern Medical Center | NULL | Completed | 18 Years | 70 Years | All | 13 | Phase 2 | United States |
| 21 | EUCTR2015-000493-35-GR (EUCTR) | 29/02/2016 | 04/01/2016 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy - The BROADEN Study | Partial lipodystrophy MedDRA version: 19.0;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide Product Code: ISIS 304801 INN or Proposed INN: ISIS 304801 Other descriptive name: ISIS 304801 | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 125 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands | ||
| 22 | EUCTR2015-000493-35-DE (EUCTR) | 17/02/2016 | 14/08/2015 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy - The BROADEN Study | Partial lipodystrophy MedDRA version: 20.0;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide Product Code: ISIS 304801 INN or Proposed INN: ISIS 304801 Other descriptive name: ISIS 304801 | Akcea Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Portugal;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands | ||
| 23 | EUCTR2015-000493-35-PT (EUCTR) | 15/02/2016 | 08/10/2015 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy - The BROADEN Study | Partial lipodystrophy MedDRA version: 20.0;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide Product Code: ISIS 304801 INN or Proposed INN: ISIS 304801 Other descriptive name: ISIS 304801 | Akcea Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2;Phase 3 | United States;Portugal;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands | ||
| 24 | NCT02684591 (ClinicalTrials.gov) | January 2016 | 15/1/2016 | Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy | Aramchol Versus Placebo in the Treatment of HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy: A Randomized, Double-blinded, Allocation-concealed, Placebo-controlled Clinical Trial | Nonalcoholic Fatty Liver Disease;HIV | Drug: Aramchol;Drug: Placebo | University of California, San Diego | NULL | Completed | 18 Years | N/A | All | 50 | Phase 2 | United States |
| 25 | NCT02639286 (ClinicalTrials.gov) | December 23, 2015 | 23/12/2015 | Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension | A Randomized, Double Blind, Placebo-Controlled Study to Assess Efficacy, Safety and Tolerability of ISIS 304801 in Patients With Partial Lipodystrophy With an Open-Label Extension | Lipodystrophy | Drug: ISIS 304801;Drug: Placebo | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 18 Years | N/A | All | 5 | Phase 2 | United States |
| 26 | EUCTR2015-000493-35-NL (EUCTR) | 15/12/2015 | 30/10/2015 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Partial Lipodystrophy - The BROADEN Study | Partial lipodystrophy MedDRA version: 18.1;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide Product Code: ISIS 304801 INN or Proposed INN: ISIS 304801 Other descriptive name: ISIS 304801 | Isis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 3 | United States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Netherlands;Germany | ||
| 27 | EUCTR2015-000493-35-ES (EUCTR) | 04/12/2015 | 15/10/2015 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Partial Lipodystrophy - The BROADEN Study | Partial lipodystrophy MedDRA version: 18.1;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide Product Code: ISIS 304801 INN or Proposed INN: ISIS 304801 Other descriptive name: ISIS 304801 | Isis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 2;Phase 3 | Portugal;United States;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Germany;Netherlands | ||
| 28 | EUCTR2015-000493-35-IT (EUCTR) | 04/12/2015 | 19/01/2021 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneouslyto Patients with Familial Partial Lipodystrophy - The BROADEN Study | Partial lipodystrophy MedDRA version: 21.1;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide Product Code: ISIS 304801 INN or Proposed INN: ISIS 304801 Other descriptive name: ISIS 304801 | IONIS PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 2;Phase 3 | United States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Germany;Netherlands | ||
| 29 | EUCTR2015-000493-35-BE (EUCTR) | 09/11/2015 | 25/09/2015 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy - The BROADEN Study | Partial lipodystrophy MedDRA version: 19.0;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide Product Code: ISIS 304801 INN or Proposed INN: ISIS 304801 Other descriptive name: ISIS 304801 | Ionis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 125 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands | ||
| 30 | NCT02527343 (ClinicalTrials.gov) | October 31, 2015 | 17/8/2015 | The BROADEN Study: A Study of Volanesorsen (Formerly ISIS-APOCIIIRx) in Patients With Familial Partial Lipodystrophy | A Randomized, Double-Blind, Placebo-Controlled, With an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Partial Lipodystrophy | Familial Partial Lipodystrophy | Drug: volanesorsen;Drug: Placebo | Ionis Pharmaceuticals, Inc. | Akcea Therapeutics | Active, not recruiting | 18 Years | N/A | All | 60 | Phase 2/Phase 3 | United States;Belgium;Brazil;Canada;Germany;Greece;Israel;Italy;Netherlands;Portugal;Russian Federation;Spain;Turkey;United Kingdom |
| 31 | NCT02654977 (ClinicalTrials.gov) | September 29, 2015 | 20/1/2015 | CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy | CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Recombinant Human Leptin (METRELEPTIN) in Various Forms of Partial Lipodystrophy | Familial Partial Lipodystrophy;Nonalcoholic Steatohepatitis;NAFLD | Drug: Metreleptin | University of Michigan | NULL | Completed | 5 Years | N/A | All | 11 | Phase 2 | United States |
| 32 | NCT03039491 (ClinicalTrials.gov) | September 1, 2015 | 30/1/2017 | Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults | Immune Response to Pneumococcal Vaccination in Aging HIV Positive Individuals | HIV Lipodystrophy;Aging | Biological: Pneumococcal polysaccharide vaccine 23 valent;Biological: 13 valent conjugated pneumococcal vaccine | Medical University of South Carolina | NULL | Completed | 21 Years | 65 Years | All | 160 | Early Phase 1 | United States |
| 33 | NCT02262806 (ClinicalTrials.gov) | October 14, 2014 | 9/10/2014 | Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy | Compassionate Use of Metreleptin in Previously-Treated Patients With Partial Lipodystrophy | Diabetes;Lipodystrophy;Hyperlipidemia | Drug: Metreleptin | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Active, not recruiting | 6 Months | N/A | All | 30 | Phase 2 | United States |
| 34 | NCT02262832 (ClinicalTrials.gov) | October 9, 2014 | 10/10/2014 | Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy | Compassionate Use of Metreleptin in Previously-Treated Patients With Generalized Lipodystrophy | Lipodystrophy;Diabetes;Hyperlipidemia | Drug: Metreleptin | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Recruiting | 6 Months | N/A | All | 30 | Phase 3 | United States |
| 35 | NCT02647853 (ClinicalTrials.gov) | October 2014 | 3/1/2016 | Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers | A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel | Nasolabial Folds;Lipoatrophy;Lipodystrophy | Drug: TAT4 Gel concentration A;Drug: TAT4 Gel concentration B;Drug: Placebo | Topokine Therapeutics, Inc. | NULL | Completed | 40 Years | 70 Years | Both | 16 | Phase 1 | United States |
| 36 | NCT02404896 (ClinicalTrials.gov) | September 16, 2014 | 20/1/2015 | Expanded Access Metreleptin Study | Expanded-Access for the Use of Metreleptin in Patients With Partial Lipodystrophy Associated With Diabetes Mellitus or Hypertriglyceridemia | Familial Partial Lipodystrophy | Drug: Metreleptin | University of Michigan | NULL | Available | 18 Years | N/A | All | United States | ||
| 37 | EUCTR2013-004539-57-PL (EUCTR) | 30/01/2014 | 16/12/2013 | A phase III, double-blind, placebo-controlled, randomized, three-arm parallel, study assessing efficacy and safety of 4 months of diosmin administration for the treatment of lower extremity teleangiectasias and gynoid lipodystrophy (edematous fibrosclerotic panniculopathy commonly known as cellulite) | A phase III, double-blind, placebo-controlled, randomized, three-arm parallel, study assessing efficacy and safety of 4 months of diosmin administration for the treatment of lower extremity teleangiectasias and gynoid lipodystrophy (edematous fibrosclerotic panniculopathy commonly known as cellulite) | lower extremity teleangiectasias and gynoid lipodystrophy (edematous fibrosclerotic panniculopathy commonly known as cellulite) MedDRA version: 17.0;Level: LLT;Classification code 10065339;Term: Cellulite;System Organ Class: 100000004858 MedDRA version: 17.0;Classification code 10043193;Term: Telangiectasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Diosminex, 500 mg, tabletki powlekane INN or Proposed INN: diosmin Other descriptive name: DIOSMIN | ALIO MEDICA Sp. z o.o. | NULL | Not Recruiting | Female: yes Male: no | Phase 3 | Poland | |||
| 38 | NCT02056912 (ClinicalTrials.gov) | January 2014 | 24/1/2014 | Identification of a New Gene Involved in Hereditary Lipodystrophy | Identification of a New Gene Involved in Hereditary Lipodystrophy - LIPOGENE | Lipodystrophy | Genetic: Amplification by PCR and direct sequencing on the entire coding sequence and intron-exons boundaries of the candidate gene;Biological: Perform blood cells and fibroblasts biochemical and immuno-labeled investigations | University Hospital, Bordeaux | NULL | Completed | 18 Years | N/A | Both | 2 | N/A | France |
| 39 | NCT01848340 (ClinicalTrials.gov) | May 2013 | 2/5/2013 | An Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Study to Describe the Pharmacokinetics of a Supratherapeutic Dose of GSK1265744 in Healthy Adult Subjects | An Open Label, Non-Randomized, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Placebo-Controlled, Randomized Study to Describe the Pharmacokinetics of a Supratherapeutic Dose of GSK1265744 in Healthy Adult Subjects | HIV-associated Lipodystrophy Syndrome | Drug: GSK1265744B (sodium salt) containing 14C-GSK1265744B;Drug: 150 mg GSK1265744B;Drug: Placebo | ViiV Healthcare | GlaxoSmithKline | Completed | 18 Years | 60 Years | Both | 16 | Phase 1 | United States |
| 40 | NCT02530827 (ClinicalTrials.gov) | March 2013 | 4/8/2015 | Energy Expenditure of People Living With HIV/AIDS | Influence of Lipid-lowering Drugs in Patients Seropositive for HIV With Lipodystrophy in Resting Energy Expenditure and Total Energy Expenditure | HIV/AIDS;HIV Lipodystrophy Syndrome | Drug: use of lipid-lowering drugs. | University of Sao Paulo General Hospital | Fundação de Amparo à Pesquisa do Estado de São Paulo | Completed | 18 Years | 60 Years | Male | 45 | N/A | NULL |
| 41 | NCT01778556 (ClinicalTrials.gov) | January 26, 2013 | 26/1/2013 | Short-term Effects of Leptin in People With Lipodystrophy | Short Term Effects of Leptin Withdrawal or Initiation in Lipodystrophy Independent of Energy Intake | Lipodystrophy | Biological: Metreleptin | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 14 Years | 70 Years | All | 25 | Phase 2 | United States |
| 42 | NCT01679197 (ClinicalTrials.gov) | October 8, 2012 | 31/8/2012 | Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy | Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy | Fatty Liver Disease, Nonalcoholic;Nonalcoholic Steatohepatitis;Lipodystrophy | Drug: Metreleptin | University of Michigan | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 5 Years | N/A | All | 23 | Phase 2 | United States |
| 43 | NCT01724580 (ClinicalTrials.gov) | October 2012 | 5/11/2012 | Compassionate Use Protocol for the Treatment of Autoinflammatory Syndromes | Compassionate Use Treatment Protocol I4V-MC-JAGA: Treatment of Conditions Expected to Benefit From JAK 1/2 Inhibition: CANDLE, CANDLE-Related Conditions, SAVI and Severe Juvenile Dermatomyositis | Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature (CANDLE);Juvenile Dermatomyositis (JDM);Stimulator of Interferon Genes (STING)-Associated Vasculopathy With Onset During Infancy (SAVI);Aicardi-Goutières Syndrome (AGS) | Drug: Baricitinib | Eli Lilly and Company | NULL | No longer available | 6 Months | N/A | All | United States;United Kingdom | ||
| 44 | NCT01788462 (ClinicalTrials.gov) | May 2012 | 1/2/2013 | Egrifta Replacement and Sleep Disordered Breathing | Egrifta Replacement and Sleep Disordered Breathing | Lipodystrophy | Drug: Tesamorelin (Egrifta) | Johns Hopkins University | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | N/A | United States |
| 45 | NCT01329744 (ClinicalTrials.gov) | June 2011 | 4/4/2011 | Effects of IGF-I in HIV Metabolic Disease | Effects of Recombinant IGF-I in HIV Associated Metabolic Disease | HIV Lipodystrophy | Drug: mecasermin;Drug: Placebo control | University of Texas Southwestern Medical Center | NULL | Terminated | 18 Years | 60 Years | Both | 16 | Phase 1 | United States |
| 46 | NCT01612858 (ClinicalTrials.gov) | June 2011 | 4/6/2012 | Metabolic Abnormalities in HIV-infected Persons | Metabolic Abnormalities in HIV-infected Persons | Lipodystrophy;HIV Infection | Drug: Metformin;Drug: Pioglitazone | Tufts Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | 70 Years | All | 20 | Phase 4 | United States |
| 47 | NCT01263717 (ClinicalTrials.gov) | December 2010 | 16/12/2010 | Effects of Growth Hormone Releasing Hormone in HIV | Effects of Growth Hormone Releasing Hormone on Fat Redistribution, Cardiovascular Indices, and Growth Hormone Secretion in HIV Lipodystrophy | HIV;HIV Lipodystrophy | Drug: tesamorelin;Drug: placebo | Massachusetts General Hospital | NULL | Completed | 18 Years | 65 Years | All | 54 | N/A | United States |
| 48 | NCT01164605 (ClinicalTrials.gov) | October 2010 | 14/7/2010 | Pilot Study of Raltegravir Lipodystrophy IISP | Pilot Study on the Efficacy of a Two Drug, Raltegravir-based Regimen,(NRTI) Sparing Antiretroviral Treatment | HIV Infection | Drug: Raltegravir | Southern California Institute for Research and Education | Merck Sharp & Dohme Corp. | Recruiting | N/A | N/A | Both | 30 | N/A | United States |
| 49 | JPRN-UMIN000002818 | 2010/08/01 | 01/01/2010 | Phase 2 trial of leptin-replacement therapy for patients with lipodystrophy | Phase 2 trial of leptin-replacement therapy for patients with lipodystrophy - Leptin-replacement therapy on lipodystrophy | lipodystrophy | administration of recombinant methionyl human leptin | Department of Medicine and Clinical Science, Kyoto University Graduate School of MedicineTranslational Research Center, Kyoto University Hospital | NULL | Complete: follow-up complete | 6years-old | Not applicable | Male and Female | 3 | Phase 2 | Japan |
| 50 | JPRN-UMIN000003679 | 2010/08/01 | 01/06/2010 | Long-term safety clinical trial of leptin-replacement therapy in patients with lipodystrophy after introduction of the treatment | Long-term safety clinical trial of leptin-replacement therapy in patients with lipodystrophy after introduction of the treatment - Long-term safety clinical trial of leptin in lipodystrophy | lipodytrophy | subcutaneous injection of human recombinant leptin | Kyoto University Hospital | NULL | Complete: follow-up complete | 6years-old | Not applicable | Male and Female | 11 | Not selected | Japan |
| 51 | NCT01023620 (ClinicalTrials.gov) | October 2009 | 30/11/2009 | HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone) | Human Immunodeficiency Virus Acquired Lipodystrophy (HAL) Classification, Measurement, & Fat Response to a Thiazolidinedione (TZD) Challenge in Differing Adult Phenotypic Presentations | HIV Infections | Drug: Pioglitazone;Other: Observation | University of Texas Southwestern Medical Center | Takeda Pharmaceuticals North America, Inc. | Completed | 18 Years | N/A | Male | 4 | N/A | United States |
| 52 | NCT00795210 (ClinicalTrials.gov) | February 2009 | 20/11/2008 | Effects of Short-term Growth Hormone in HIV-infected Patients | Effects of Short-term Growth Hormone in HIV-infected Patients | HIV Lipodystrophy | Drug: Growth hormone;Drug: Growth Hormone Releasing Hormone | Massachusetts General Hospital | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | 60 Years | All | 25 | N/A | United States |
| 53 | NCT00865007 (ClinicalTrials.gov) | December 2008 | 18/3/2009 | Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy | A Phase IV-III Comparative, Randomized, Open-label Study to Evaluate the Efficacy for the Recovery of Peripheral Fat (or of the Extremities) of Lopinavir/Ritonavir in Monotherapy Versus Abacavir/Lamivudine and Lopinavir/Ritonavir | HIV Infection;Lipodystrophy;HIV Infections | Drug: Monotherapy (Lopinavir/ritonavir);Drug: Monotherapy (Lopinavir/ritonavir) + ABC/3TC | Fundacion SEIMC-GESIDA | Abbott | Completed | 18 Years | N/A | Both | 88 | Phase 4 | Spain |
| 54 | NCT00677313 (ClinicalTrials.gov) | November 2008 | 12/5/2008 | An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy | An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy | Lipodystrophy | Drug: metreleptin | Bristol-Myers Squibb | NULL | Active, not recruiting | 5 Years | N/A | Both | 41 | N/A | United States |
| 55 | NCT00656175 (ClinicalTrials.gov) | September 2008 | 2/4/2008 | Raltegravir Therapy for Women With HIV and Fat Accumulation | Phase II Study of Raltegravir as Replacement for Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Based Antiretroviral Therapy in Women With Fat Accumulation | HIV Infections;Lipodystrophy | Drug: raltegravir | University of California, Los Angeles | Merck Sharp & Dohme Corp.;Case Western Reserve University;Vanderbilt University;Tufts University;University Health Network, Toronto | Completed | 18 Years | N/A | Female | 39 | Phase 2 | United States;Canada |
| 56 | EUCTR2007-003233-16-ES (EUCTR) | 11/12/2007 | 22/10/2007 | A multicenter, double-blind, randomized, placebo-controlled extension study assessing the efficacy and long-term safety of a 2mg dose of TH9507, a growth hormone releasing factor analog, in HIV subjects with excess abdominal fat accumulation.Estudio de extesión, multicéntrico, doble ciego, aleatorizado, controlado con placebo para evaluar la eficacia y seguridad a largo plazo de una dosis de 2 mg de TH9507, un análogo del factor liberador de la hormona de crecimiento, en sujetos con VIH con acumulación excesiva de grasa abdominal. | A multicenter, double-blind, randomized, placebo-controlled extension study assessing the efficacy and long-term safety of a 2mg dose of TH9507, a growth hormone releasing factor analog, in HIV subjects with excess abdominal fat accumulation.Estudio de extesión, multicéntrico, doble ciego, aleatorizado, controlado con placebo para evaluar la eficacia y seguridad a largo plazo de una dosis de 2 mg de TH9507, un análogo del factor liberador de la hormona de crecimiento, en sujetos con VIH con acumulación excesiva de grasa abdominal. | Lipodistrofia asociada a VIH.HIV-associated lipodystrophy. MedDRA version: 9.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: Tesamorelin Product Code: TH9507 INN or Proposed INN: Tesamorelin Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | United Kingdom;Belgium;France;Spain | |||
| 57 | EUCTR2007-003233-16-GB (EUCTR) | 29/11/2007 | 02/08/2007 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. | A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. | HIV-associated lipodystrophy MedDRA version: 9.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: Tesamorelin Product Code: TH9507 INN or Proposed INN: Tesamorelin Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Belgium;United Kingdom | ||
| 58 | EUCTR2007-003233-16-FR (EUCTR) | 19/09/2007 | 31/07/2007 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. | A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. | HIV-associated lipodystrophy MedDRA version: 9.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: Tesamorelin Product Code: TH9507 INN or Proposed INN: Tesamorelin Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | United Kingdom;Belgium;France;Spain | |||
| 59 | EUCTR2007-003233-16-BE (EUCTR) | 05/09/2007 | 22/08/2007 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. | A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. | HIV-associated lipodystrophy MedDRA version: 9.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: Tesamorelin Product Code: TH9507 INN or Proposed INN: Tesamorelin Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | United Kingdom;Belgium;France;Spain | |||
| 60 | NCT00608023 (ClinicalTrials.gov) | August 2007 | 23/1/2008 | TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy | A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study Assessing the Efficacy and Long-term Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Subjects With Excess Abdominal Fat Accumulation | Lipodystrophy;HIV Infections | Drug: Tesamorelin;Drug: Placebo for Tesamorelin | Theratechnologies | NULL | Completed | 18 Years | 65 Years | All | 263 | Phase 3 | United States;Belgium;Canada;France;Spain;United Kingdom |
| 61 | EUCTR2006-005444-88-DE (EUCTR) | 21/06/2007 | 14/08/2007 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | HIV-associated lipodystrophy MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: TH9507 Product Code: TH9507 Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | United Kingdom;Germany;France;Spain | |||
| 62 | EUCTR2006-005444-88-GB (EUCTR) | 08/05/2007 | 26/01/2007 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | HIV-associated lipodystrophy MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: TH9507 Product Code: TH9507 Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Belgium;Germany;United Kingdom | ||
| 63 | EUCTR2006-005444-88-ES (EUCTR) | 25/04/2007 | 03/03/2010 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation.Estudio aleatorizado, doble ciego, multicéntrico y controlado por placebo, en el que se evalúa la eficacia y la seguridad de una dosis de 2 mg de TH9507, una sustancia análoga al factor liberador de la hormona del crecimiento, para pacientes de VIH con acumulación excesiva de tejido adiposo abdominal. | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation.Estudio aleatorizado, doble ciego, multicéntrico y controlado por placebo, en el que se evalúa la eficacia y la seguridad de una dosis de 2 mg de TH9507, una sustancia análoga al factor liberador de la hormona del crecimiento, para pacientes de VIH con acumulación excesiva de tejido adiposo abdominal. | HIV-associated lipodystrophyLipodistrofia asociada al VIH MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: TH9507 Product Code: TH9507 Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Germany;United Kingdom;France;Spain | |||
| 64 | EUCTR2006-005444-88-FR (EUCTR) | 15/02/2007 | 11/01/2007 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | HIV-associated lipodystrophy MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: TH9507 Product Code: TH9507 Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Germany;United Kingdom;France;Spain | |||
| 65 | EUCTR2006-005444-88-BE (EUCTR) | 16/01/2007 | 21/12/2006 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | HIV-associated lipodystrophy MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: TH9507 Product Code: TH9507 Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | France;Spain;Belgium;Germany;United Kingdom | |||
| 66 | NCT00362440 (ClinicalTrials.gov) | August 2006 | 9/8/2006 | Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome | A Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome: A Randomized, Double-blind, Placebo-controlled Clinical Trial | HIV Lipodystrophy | Drug: Leptin;Drug: Pioglitazone or metformin;Drug: Placebo | Beth Israel Deaconess Medical Center | American Diabetes Association | Completed | 18 Years | N/A | All | 9 | Phase 2 | United States |
| 67 | NCT00426296 (ClinicalTrials.gov) | August 2006 | 23/1/2007 | SHARE: Simple HAART With Abacavir, Reyataz, and Epivir | An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of Abacavir 600 mg/Lamivudine 300 mg Once-Daily in Combination With Atazanavir 300 mg + Ritonavir 100 mg Once-Daily in Antiretroviral-Naïve HIV-1 Infected Subjects With Continuing Evaluation of Abacavir/Lamivudine Plus Atazanavir 400 mg for Maintenance Over an Additional 48 Weeks | HIV Infections;Lipodystrophy | Drug: atazanavir (Reyataz);Drug: ritonavir (Norvir) | Clinical Alliance for Research & Education - Infectious Diseases, LLC. | GlaxoSmithKline | Recruiting | 18 Years | N/A | Both | Phase 4 | United States | |
| 68 | NCT00457639 (ClinicalTrials.gov) | April 2006 | 4/4/2007 | Cholic Acid for Hepatic Steatosis in Lipodystrophy | Phase II Study of Cholic Acid for Hepatic Steatosis in Lipodystrophy Patients | Hepatic Steatosis | Drug: Cholic Acid | University of Texas Southwestern Medical Center | FDA Office of Orphan Products Development | Completed | 6 Years | 70 Years | All | 18 | Phase 2 | United States |
| 69 | NCT00896298 (ClinicalTrials.gov) | April 2006 | 8/5/2009 | Trial of Leptin Replacement Therapy in Patients With Lipodystrophy | Double-Blind, Placebo-Controlled Trial of Leptin Replacement Therapy in Patients With Lipodystrophy | Hypoleptinemia;Generalized Lipodystrophy;Partial Lipodystrophy;Insulin Resistance | Drug: Leptin;Drug: Placebo | University of Texas Southwestern Medical Center | NULL | Completed | 6 Years | 70 Years | All | 25 | Phase 2/Phase 3 | United States |
| 70 | EUCTR2005-004665-42-IT (EUCTR) | 17/03/2006 | 21/04/2006 | Evaluation of the efficacy and tollerability of long-term somministration of Acetyl-l-carnitine in the treatment of HIV related lipodystrophy.Parallel group, randomized, double blind, controlled versus placebo study. - ND | Evaluation of the efficacy and tollerability of long-term somministration of Acetyl-l-carnitine in the treatment of HIV related lipodystrophy.Parallel group, randomized, double blind, controlled versus placebo study. - ND | HIV related LIPODYSTROPHY. MedDRA version: 6.1;Level: PT;Classification code 10061624 | Product Name: ACETYL- L- CARNITINE Product Code: ST200 INN or Proposed INN: Acetylcarnitine | SIGMA-TAU | NULL | Not Recruiting | Female: yes Male: yes | 40 | Italy | |||
| 71 | EUCTR2004-002740-10-DE (EUCTR) | 07/11/2005 | 04/10/2005 | A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised Protocol 03, version v8.0, incorporating Protocol Amendments 03, 04 and 05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY | A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised Protocol 03, version v8.0, incorporating Protocol Amendments 03, 04 and 05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY | HIV-infected individuals with lipodystrophy | Trade Name: Reyataz Product Name: Reyataz Product Code: BMS-232632 INN or Proposed INN: Atazanavir Other descriptive name: ATV Trade Name: Norvir Product Name: Norvir INN or Proposed INN: Ritonavir Other descriptive name: RTV | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | United Kingdom;Germany;Spain;Italy | ||
| 72 | EUCTR2005-004021-26-GB (EUCTR) | 06/10/2005 | 05/09/2005 | Longitudinal relationship between lipodystrophy and adipocyte mitochondria DNA in HIV Patients: comparison between Efavirenz (Sustiva) plus AZT/3TC (Combivir) and a less mitochrondial DNA-toxic regimen - Tenefovir/Emtricitabine (Truvada) plus Efavirenz. - Mitochondrial DNA Study | Longitudinal relationship between lipodystrophy and adipocyte mitochondria DNA in HIV Patients: comparison between Efavirenz (Sustiva) plus AZT/3TC (Combivir) and a less mitochrondial DNA-toxic regimen - Tenefovir/Emtricitabine (Truvada) plus Efavirenz. - Mitochondrial DNA Study | HIV | Trade Name: SUSTIVA Product Name: Efavirenz Trade Name: COMBIVIR Product Name: AZT/3TC Trade Name: TRUVADA Product Name: emtricitabine/tenofovir | University Hospital Birmingham | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yes | United Kingdom | ||
| 73 | NCT00656851 (ClinicalTrials.gov) | September 2005 | 10/4/2008 | Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome | Myocardial Function, Free Fatty Acid and Glucose Metabolism in HIV Metabolic Syndrome | HIV Infections;Cardiovascular Disease;Insulin Resistance;HIV Lipodystrophy;The Metabolic Syndrome | Drug: Pioglitazone;Behavioral: Exercise Training | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 28 Years | 50 Years | All | 24 | N/A | United States |
| 74 | EUCTR2004-002740-10-IT (EUCTR) | 04/07/2005 | 24/01/2006 | A phase IV, open-label, randomized, multicenter trial assessing a reyataz-based substitution approach in the management of lipodystrophy syndrome. | A phase IV, open-label, randomized, multicenter trial assessing a reyataz-based substitution approach in the management of lipodystrophy syndrome. | HIV MedDRA version: 6.1;Level: PT;Classification code 10049287 | Trade Name: REYATAZ 150MG 60 CPS BL INN or Proposed INN: atazanavir | BRISTOL-M.SQUIBB | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Germany;United Kingdom;Spain;Italy | ||
| 75 | NCT00135356 (ClinicalTrials.gov) | July 2005 | 25/8/2005 | Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome | A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing a Reyataz-Based Substitution Approach in the Management of Lipodystrophy Syndrome. Research Into Atazanavir in Lipodystrophy (The REAL Study) | HIV-Associated Lipodystrophy Syndrome | Drug: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs);Drug: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs) | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 219 | Phase 4 | United States;Canada;France;Germany;Italy;Mexico;Poland;Spain;United Kingdom;Netherlands |
| 76 | NCT00123253 (ClinicalTrials.gov) | June 2005 | 20/7/2005 | TH9507 in Patients With HIV-Associated Lipodystrophy | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Patients With Excess of Abdominal Fat Accumulation | HIV Infections;Lipodystrophy | Drug: TH9507 | Theratechnologies | NULL | Completed | 18 Years | 65 Years | Both | 412 | Phase 3 | United States;Canada |
| 77 | EUCTR2004-002740-10-ES (EUCTR) | 16/05/2005 | 17/05/2006 | A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05. - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY | A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05. - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY | HIV-infected individuals with lipodystrophy | Trade Name: Reyataz Product Name: Reyataz Product Code: BMS-232632 INN or Proposed INN: Atazanavir Other descriptive name: ATV Trade Name: Norvir Product Name: Norvir INN or Proposed INN: Ritonavir Other descriptive name: RTV | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Germany;United Kingdom;Spain;Italy | ||
| 78 | EUCTR2004-002740-10-GB (EUCTR) | 12/05/2005 | 19/04/2005 | A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05, andRevised Protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY | A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05, andRevised Protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY | HIV-infected individuals with lipodystrophy | Trade Name: Reyataz Product Name: Reyataz Product Code: BMS-232632 INN or Proposed INN: Atazanavir Other descriptive name: ATV Trade Name: Norvir Product Name: Norvir INN or Proposed INN: Ritonavir Other descriptive name: RTV | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Spain;Germany;Italy;United Kingdom | ||
| 79 | NCT00119379 (ClinicalTrials.gov) | April 2005 | 11/7/2005 | Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults | Reversibility of Mitochondrial Toxicity in HIV Lipoatrophy | HIV Infections;Lipodystrophy;Metabolic Diseases;Nutrition Disorders | Drug: NucleomaxX;Drug: Tenofovir Disoproxil Fumarate | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | N/A | All | 50 | Phase 2 | United States |
| 80 | NCT00130286 (ClinicalTrials.gov) | March 2005 | 12/8/2005 | Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance | Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Recombinant Human Growth Hormone and/or Rosiglitazone in the Treatment of Human Immunodeficiency Virus-Associated Visceral Adiposity and Insulin Resistance | HIV-Associated Lipodystrophy Syndrome;Insulin Resistance;HIV Infections;Metabolic Syndrome X;Body Weight Changes | Drug: Rosiglitazone;Drug: Recombinant human growth hormone + rosiglitazone | Weill Medical College of Cornell University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | 65 Years | All | 77 | Phase 1/Phase 2 | United States |
| 81 | NCT00119769 (ClinicalTrials.gov) | February 2005 | 7/7/2005 | The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients | The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients on Highly Active Antiretroviral Therapy (HAART) | HIV Infections;Lipodystrophy | Drug: Placebo;Drug: Genotropin (human recombinant Growth hormone) | Hvidovre University Hospital | Pfizer | Completed | 21 Years | 60 Years | Male | 46 | Phase 4 | Denmark |
| 82 | NCT00639457 (ClinicalTrials.gov) | January 2005 | 18/3/2008 | Exercise and Pioglitazone for HIV-Metabolic Syndromes | Exercise and Pioglitazone for HIV-Metabolic Syndromes | HIV Infections;Type 2 Diabetes;Obesity;HIV;AIDS;Cardiovascular Disease;Lipodystrophy | Drug: Pioglitazone;Behavioral: Exercise training | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 18 Years | 65 Years | All | 44 | N/A | United States |
| 83 | NCT00192621 (ClinicalTrials.gov) | November 2004 | 12/9/2005 | Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects | A 3 Arm, Prospective Study to Compare the Effect of 6 Weeks Exposure to the Combination of Lopinavir (LPVr)/Combivir® (AZT/3TC) Versus Lopinavir Alone or Combivir® Alone in HIV-negative Healthy Subjects on the Development of Abnormalities of Lipid and Glucose Metabolism | HIV Infections;Dyslipidemias;Glucose Metabolism Disorders;Metabolic Diseases;Lipodystrophy;Cardiovascular Disease | Drug: Combivir (zidovudine [AZT] / lamivudine [3TC]);Drug: Kaletra (lopinavir [LPVr]) | Kirby Institute | St Vincent's Hospital, Sydney;National Heart, Lung, and Blood Institute (NHLBI);Garvan Institute of Medical Research;Prince of Wales Hospital, Sydney | Completed | 18 Years | N/A | Both | 50 | Phase 4 | Australia |
| 84 | NCT00082628 (ClinicalTrials.gov) | May 2004 | 13/5/2004 | Treatment of Abnormal Adipose Tissue Accumulation in HIV Patients | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Serostim®, r-hGH in the Treatment and Maintenance of Human Immunodeficiency HIV-Associated Adipose Redistribution Syndrome, or HARS | HIV Infections;Lipodystrophy | Drug: Serostim®[somatropin (rDNA origin) for injection] | EMD Serono | NULL | Completed | 18 Years | 60 Years | Both | 569 | Phase 3 | United States;Canada |
| 85 | NCT00139178 (ClinicalTrials.gov) | March 2004 | 30/8/2005 | Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. | Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities | HIV Associated Lipodystrophy Syndrome.;HIV;Hypercholesterolemia;Lipoatrophy | Drug: Different HAART regimens | Danish HIV Research Group | Odense University Hospital;Rigshospitalet, Denmark;Hvidovre University Hospital;Aarhus University Hospital | Completed | 18 Years | N/A | Both | 100 | Phase 4 | Denmark |
| 86 | NCT00100698 (ClinicalTrials.gov) | January 2004 | 4/1/2005 | Physiologic Growth Hormone Effects in HIV Lipodystrophy | Physiologic Growth Hormone Effects in HIV Lipodystrophy | AIDS;HIV Infections | Drug: recombinant human growth hormone;Drug: placebo | Massachusetts General Hospital | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | 60 Years | All | 56 | N/A | United States |
| 87 | NCT00122668 (ClinicalTrials.gov) | November 2003 | 21/7/2005 | Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients | Randomized Comparative Study Evaluating the Rate of Occurrence of a Lipoatrophy Syndrome in ARVnaive HIV-1 Infected Patients Receiving NRTI-Sparing Antiretroviral Regimen (Hippocampe - ANRS 121) | HIV Infections;HIV-Associated Lipodystrophy Syndrome | Drug: non-nucleoside reverse transcriptase inhibitors;Drug: nucleoside reverse transcriptase inhibitors;Drug: protease inhibitor | French National Agency for Research on AIDS and Viral Hepatitis | NULL | Terminated | 18 Years | N/A | Both | 112 | Phase 4 | France |
| 88 | NCT00135460 (ClinicalTrials.gov) | June 2003 | 25/8/2005 | Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients | Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial. | HIV-Associated Lipodystrophy Syndrome | Drug: nucleoside analogue sparing HAART regimen | Danish HIV Research Group | Rigshospitalet, Denmark;Hvidovre University Hospital;Odense University Hospital;Aarhus University Hospital;Aalborg Universitetshospital;Abbott | Active, not recruiting | 18 Years | N/A | Both | 100 | Phase 4 | Denmark |
| 89 | NCT00647946 (ClinicalTrials.gov) | February 2003 | 27/3/2008 | Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue | A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly Active Antiretroviral Therapy (HAART) | Lipodystrophy | Drug: tenofovir DF;Drug: abacavir 300mg twice daily | Gilead Sciences | NULL | Completed | 18 Years | N/A | Both | 100 | Phase 2 | United Kingdom |
| 90 | NCT01511016 (ClinicalTrials.gov) | February 2003 | 11/1/2012 | Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome | The Effect of Leptin Therapy on Abnormal Lipid Kinetics in Subjects With HIV Lipodystrophy Syndrome | HIV Lipodystrophy | Drug: Human recombinant leptin (metreleptin);Drug: Placebo | Baylor College of Medicine | NULL | Completed | 18 Years | 64 Years | Male | 17 | N/A | United States |
| 91 | NCT00148850 (ClinicalTrials.gov) | February 2003 | 7/9/2005 | Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients | A Randomized, Phase 3, Double Blind, Multicentre Trial, Evaluating the Effect of Pioglitazone Versus Placebo on Change in Lipoatrophy in HIV- 1 Infected Patients Treated With Stable Antiretroviral Therapy for at Least 6 Months.ANRS 113 LIPIOT Study | HIV-Associated Lipodystrophy Syndrome;HIV Infections | Drug: Pioglitazone | French National Agency for Research on AIDS and Viral Hepatitis | Takeda | Terminated | 18 Years | N/A | Both | 130 | Phase 3 | France |
| 92 | NCT00192660 (ClinicalTrials.gov) | February 2003 | 12/9/2005 | HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001) | Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Structure in HIV-infected Individuals, Naive to Therapy, Who Are Starting Therapy for the First Time | HIV-Associated Lipodystrophy Syndrome;Cardiovascular Disease | Drug: Lamivudine;Drug: Stavudine;Drug: Didanosine;Drug: Zidovudine;Drug: Tenofovir;Drug: Abacavir;Drug: Efavirenz (EFV);Drug: Nevirapine;Drug: Indinavir;Drug: Saquinavir;Drug: Amprenavir;Drug: Ritonavir;Drug: Nelfinavir;Drug: Tipranavir;Drug: enfuvirtide (T20) | Kirby Institute | St Vincent's Hospital, Sydney;National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | N/A | Both | 80 | Phase 4 | Australia |
| 93 | NCT00122226 (ClinicalTrials.gov) | January 2003 | 14/7/2005 | MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS) | MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS) | HIV Infections;HIV-Associated Lipodystrophy Syndrome | Drug: Lopinavir/ritonavir + zidovudine + lamivudine;Drug: Lopinavir/ritonavir + nevirapine | VU University Medical Center | Abbott;Boehringer Ingelheim | Active, not recruiting | 18 Years | 70 Years | Male | 50 | Phase 4 | Finland;Netherlands;Spain;United Kingdom |
| 94 | NCT00461552 (ClinicalTrials.gov) | January 2003 | 16/4/2007 | Therapeutic Approaches to HAART-Induced Lipodystrophy | Therapeutic Approaches to HAART-Induced Lipodystrophy | HIV Infections;Lipodystrophy | Drug: Leptin;Other: Placebo | University of Texas Southwestern Medical Center | Amylin Pharmaceuticals, LLC. | Completed | 14 Years | 65 Years | All | 23 | Phase 2 | United States |
| 95 | NCT00246402 (ClinicalTrials.gov) | September 2002 | 27/10/2005 | Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV | Anti-Lipolytic Strategy for HIV Lipodystrophy | Insulin Resistance;Cardiovascular Diseases;Heart Diseases;HIV Infections;Hypertriglyceridemia;Hyperlipidemia | Drug: Acipimox | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 18 Years | 65 Years | Both | 30 | N/A | United States |
| 96 | NCT00202228 (ClinicalTrials.gov) | July 2002 | 13/9/2005 | Lactate Metabolism Study in HIV Infected Persons | Lactic Acid Metabolism in HIV-Infected Persons. Predicting Abnormalities in Lactate Production and Clearance Related to Treatment and Liver Disease and Measuring the Impact of Vitamin Supplementation. | HIV Infections;AIDS;Lactic Acidosis;Lipodystrophy | Drug: cofactor supplementation (thiamine, riboflavin, L-carnitine) | Queen's University | Ontario HIV Treatment Network | Completed | 18 Years | N/A | Both | 30 | Phase 4 | Canada |
| 97 | NCT00028314 (ClinicalTrials.gov) | March 2002 | 20/12/2001 | Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients | A Restrictively Randomized, Open-Label, Controlled, Pilot Study of the Effect of a Thymidine Analogue Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral Fat Wasting | HIV Infections;Lipodystrophy;Wasting Disease | Drug: Abacavir sulfate;Drug: Atazanavir/Ritonavir;Drug: Lopinavir/Ritonavir;Drug: Nevirapine | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 13 Years | N/A | Both | 150 | N/A | United States |
| 98 | NCT00457665 (ClinicalTrials.gov) | February 2002 | 4/4/2007 | Mechanisms of Lipodystrophy in HIV-Infected Pateints | Mecahnisms of Lipodystrophy in HIV-Infected Patients | HIV Infections | Drug: Nelfinavir;Drug: Efavirenz | University of Texas Southwestern Medical Center | Bristol-Myers Squibb;GlaxoSmithKline | Completed | 18 Years | 70 Years | All | 56 | Phase 4 | United States |
| 99 | NCT00646984 (ClinicalTrials.gov) | January 2002 | 26/3/2008 | Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy | Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy. | HIV-Associated Lipodystrophy Syndrome | Drug: Standard continuous antiretroviral therapy;Drug: CD-4 guided therapy interruption;Drug: Viral load driven treatment interruption | Hospital Clinic of Barcelona | NULL | Completed | 18 Years | N/A | Both | 147 | Phase 4 | Spain |
| 100 | NCT00140244 (ClinicalTrials.gov) | December 2001 | 30/8/2005 | Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome | Role of Leptin in Highly Active Antiretroviral Therapy (HAART)-Induced Lipodystrophy and Metabolic Syndrome in HAART-Treated HIV Patients | HAART-induced Lipodystrophy and Metabolic Syndrome | Drug: r-metHuLeptin;Drug: Placebo | Beth Israel Deaconess Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);Amgen | Completed | 18 Years | N/A | All | 7 | Phase 2 | United States |
| 101 | NCT00025883 (ClinicalTrials.gov) | October 2001 | 27/10/2001 | Leptin to Treat Lipodystrophy | Long-Term Efficacy of Leptin Replacement in Treatment of Lipodystrophy | Lipodystrophy | Drug: Metreleptin | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 6 Months | N/A | All | 103 | Phase 2 | United States |
| 102 | NCT00227500 (ClinicalTrials.gov) | July 2001 | 27/9/2005 | Pravastatin for Hyperlipidaemia in HIV. | A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV | HIV Infections;Lipid Metabolism;Glucose Metabolism;Metabolic Abnormality;Lipodystrophy;Cardiovascular Disease | Drug: Pravastatin | Kirby Institute | The University of New South Wales;National Heart, Lung, and Blood Institute (NHLBI);Garvan Institute of Medical Research;St Vincent's Hospital, Sydney | Completed | 18 Years | N/A | Both | 40 | Phase 4 | Australia |
| 103 | NCT00017758 (ClinicalTrials.gov) | June 2001 | 11/6/2001 | The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs | The Effect of Efavirenz and Nelfinavir on the Pharmacokinetics of Hydroxymethylglutaryl Coenzyme A Reductase Inhibitors | HIV Infections;HIV Seronegativity;Lipodystrophy | Drug: Pravastatin sodium;Drug: Simvastatin;Drug: Atorvastatin calcium;Drug: Nelfinavir mesylate;Drug: Efavirenz | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 60 Years | Both | 56 | Phase 1 | United States |
| 104 | NCT00021463 (ClinicalTrials.gov) | April 2001 | 14/7/2001 | Changing to Nonprotease Inhibitor Treatment to Improve Side Effects | Phase II, Randomized, Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic Abnormalities | HIV Infections;Lipodystrophy | Drug: Abacavir sulfate, Lamivudine and Zidovudine;Drug: Abacavir sulfate;Drug: Efavirenz;Drug: Nevirapine | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 13 Years | N/A | Both | 342 | Phase 2 | United States |
| 105 | NCT00015691 (ClinicalTrials.gov) | April 2001 | 1/5/2001 | Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients With Insulin and Fat Abnormalities | A Randomized, Double-Blind, Placebo-Controlled Study of Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Subjects With Hyperinsulinemia and Elevated Waist/Hip Ratio | HIV Infections;Lipodystrophy;Hyperinsulinemia | Drug: Metformin hydrochloride;Drug: Rosiglitazone maleate | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 65 Years | Both | 105 | N/A | United States |
| 106 | NCT00122655 (ClinicalTrials.gov) | January 2001 | 21/7/2005 | Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy | A Randomized Prospective Study Evaluating the Impact on Fat Distribution of NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy ANRS 108 NONUKE Study | HIV Infections;HIV Lipodystrophy Syndrome | Drug: non-nucleoside reverse transcriptase inhibitors;Drug: nucleoside reverse transcriptase inhibitors;Drug: protease inhibitors | French National Agency for Research on AIDS and Viral Hepatitis | NULL | Terminated | 18 Years | N/A | Both | 100 | Phase 4 | France |
| 107 | NCT00006190 (ClinicalTrials.gov) | November 2000 | 25/8/2000 | A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy | The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients | HIV Infections;Lipodystrophy | Drug: Nelfinavir mesylate;Drug: Stavudine;Drug: Lamivudine;Drug: Efavirenz | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 18 Years | 70 Years | Both | Phase 4 | United States | |
| 108 | NCT00006412 (ClinicalTrials.gov) | October 25, 2000 | 13/10/2000 | Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids | A Prospective, Multicenter, Randomized Trial Comparing the Efficacy and Safety of Fenofibrate Versus Pravastatin in HIV-Infected Subjects With Lipid Abnormalities | HIV Infections;Lipodystrophy | Drug: Pravastatin sodium;Drug: Fenofibrate | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | N/A | All | 630 | Phase 3 | United States;Puerto Rico |
| 109 | NCT00005905 (ClinicalTrials.gov) | June 2000 | 9/6/2000 | Leptin to Treat Lipodystrophy | Efficacy of Leptin Replacement in Treatment of Lipodystrophy | Lipodystrophy | Drug: hu Leptin (A-100) | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | N/A | N/A | Both | 20 | Phase 2 | United States |
| 110 | NCT00005764 (ClinicalTrials.gov) | May 2000 | 30/5/2000 | A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients | Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL) | HIV Infections;Lipodystrophy | Drug: Lamivudine/Zidovudine;Drug: Abacavir sulfate;Drug: Lamivudine | Glaxo Wellcome | NULL | Completed | 18 Years | N/A | Both | 100 | Phase 4 | United States |
| 111 | NCT00006185 (ClinicalTrials.gov) | September 1999 | 22/8/2000 | Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome | Cellular Mechanisms for Metabolic Dysfunction in HIV | HIV Infections;Lipodystrophy;Insulin Resistance | Drug: Avandia administration for 6-12 weeks | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 18 Years | 55 Years | Both | Phase 1 | United States | |
| 112 | NCT00002417 (ClinicalTrials.gov) | March 1998 | 2/11/1999 | A Study of Amprenavir in Patients With Protease Inhibitor-Related Complications | An Open-Label Study to Evaluate the Safety and Tolerance of Amprenavir (141W94) Combination Therapy in Protease Inhibitor Experienced Subjects Who Are Intolerant (Hyperlipidemia With or Without Lipodystrophy) But Not Failing Their Current Protease Inhibitor Therapy | HIV Infections | Drug: Amprenavir | Glaxo Wellcome | NULL | Completed | 13 Years | N/A | Both | N/A | United States |