265. 脂肪萎縮症 [臨床試験数:109,薬物数:164(DrugBank:59),標的遺伝子数:26,標的パスウェイ数:94

Searched query = "Lipodystrophy", "Berardinelli-Seip syndrome", "Lawrence syndrome", "Barraquer-Simons syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04517253
(ClinicalTrials.gov)
October 27, 202017/8/2020A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGSA Phase 2/3, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Baricitinib in Adult and Pediatric Japanese Patients With NNS/CANDLE, SAVI, and AGSNakajo-Nishimura Syndrome;Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature Syndrome;STING-Associated Vasculopathy With Onset in Infancy;Aicardi Goutieres SyndromeDrug: BaricitinibEli Lilly and CompanyNULLRecruiting6 MonthsN/AAll5Phase 2/Phase 3Japan
2NCT04340388
(ClinicalTrials.gov)
June 20201/4/2020Contribution of Dolutegravir to Obesity and Cardiovascular DiseaseContribution of the Integrase Inhibitor Dolutegravir to Obesity and Cardiovascular Disease in Persons Living With HIVHIV-1-infection;Antiviral Drug Adverse Reaction;Vascular Diseases;Cardiovascular Abnormalities;Abnormality of Adipose Tissue;Body Weight Changes;Body Fat Disorder;HIV-Associated Lipodystrophy SyndromeDrug: Dolutegravir 50 MG;Drug: Antiretroviral/Anti HIVAugusta UniversityNULLNot yet recruiting18 Years100 YearsAll30Phase 4NULL
3NCT04159415
(ClinicalTrials.gov)
January 7, 20207/11/2019Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized LipodystrophyA Randomized, Double-Blind, Placebo-Controlled Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized LipodystrophyGeneralized LipodystrophyDrug: Placebo;Drug: Low-Dose REGN4461;Drug: High-dose REGN4461Regeneron PharmaceuticalsNULLActive, not recruiting12 YearsN/AAll26Phase 2United States
4NCT04056000
(ClinicalTrials.gov)
September 1, 201923/5/2019Lipodystrophy and Fat Metabolism During ExerciseThe Regulation of Fat Metabolism in a Cyclist With Lipodystrophy: a Case StudyHealthy;Lipodystrophy, Familial PartialDietary Supplement: Caffeine;Dietary Supplement: High-carbohdyrate breakfast;Behavioral: 60-minutes of steady state exerciseUniversity of ExeterNULLNot yet recruiting18 Years35 YearsMale5N/AUnited Kingdom
5NCT03900286
(ClinicalTrials.gov)
July 16, 201926/3/2019Low Energy Diet and Familial Partial LipodystrophyEvaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and DiabetesLipodystrophy;Diabetes;Diet ModificationDietary Supplement: Total Dietary ReplacementCambridge University Hospitals NHS Foundation TrustNULLNot yet recruiting18 Years99 YearsAll20N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03936829
(ClinicalTrials.gov)
April 28, 201925/4/2019Cyclophosphamide in the Treatment of Associated Acquired Lipodystrophy Syndrome With Type 1 DiabetesCyclophosphamide in the Treatment of Panniculitis Associated Acquired Lipodystrophy Syndrome With Type 1 DiabetesLipodystrophy Acquired;Type1diabetesDrug: CyclophosphamideChildren's Hospital of Fudan UniversityNULLRecruitingN/AN/AAll10N/AChina
7NCT04026178
(ClinicalTrials.gov)
November 14, 201830/10/2018Immunogenicity of Metreleptin in Patients With Generalized LipodystrophyA 36-Month, Multicenter, Open Label Phase 4 Study to Evaluate the Immunogenicity of Daily SC Metreleptin Treatment in Patients With Generalized LipodystrophyGeneralized LipodystrophyDrug: MetreleptinAegerion Pharmaceuticals, Inc.NULLRecruiting1 YearN/AAll10Phase 4United States
8EUCTR2017-003014-22-AT
(EUCTR)
25/06/201829/05/2018Leptin in hepatic lipid metabolism in humansThe 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 ViennaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
43Phase 2Austria
9NCT03514420
(ClinicalTrials.gov)
May 30, 201821/4/2018Study 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 LipodystrophyFamilial Partial LipodystrophyDrug: AKCEA-ANGPTL3-LRXAkcea TherapeuticsIonis Pharmaceuticals, Inc.Completed18 YearsN/AAll4Phase 2United States
10NCT03508687
(ClinicalTrials.gov)
March 13, 20183/4/2018Study of Gemcabene in Adults With FPLDAn Investigator-Initiated Open-Label, Randomized Study of Gemcabene in Adults With Familial Partial Lipodystrophy Disease (FPLD)Familial Partial Lipodystrophy;Hypertriglyceridemia;Fatty Liver;NASH - Nonalcoholic SteatohepatitisDrug: 300mg Gemcabene;Drug: 600mg GemcabeneElif OralNULLCompleted18 YearsN/AAll5Phase 1/Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03226821
(ClinicalTrials.gov)
February 7, 201820/7/2017Body Composition and Adipose Tissue in HIVBody Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin TherapyHIV Lipodystrophy Syndrome;Growth Hormone Deficiency;Body CompositionDrug: TesamorelinColumbia UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting18 Years68 YearsAll24Phase 4United States
12NCT03262610
(ClinicalTrials.gov)
February 17, 201722/8/2017Setemelanotide in a Single Patient With Partial LipodystrophyExpanded-access for the Use of Setemelanotide in a Single Patient With Partial Lipodystrophy (LD) Associated With Leptin Deficiency and Multiple Autoimmune DiseasesHypertriglyceridemiaDrug: SetmelanotideRhythm Pharmaceuticals, Inc.NULLNo longer available15 Years15 YearsFemaleUnited States
13EUCTR2015-004846-25-BE
(EUCTR)
15/07/201630/03/2016Anti-oxLDL IgM antibodies as a novel therapy for metabolic lipid diseasesImmunization 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 UniversityNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Belgium
14NCT02430077
(ClinicalTrials.gov)
June 201624/4/2015Phase 2 Study of Obeticholic Acid for Lipodystrophy PatientsPhase 2 Study of Obeticholic Acid for Lipodystrophy PatientsFamilial Partial LipodystrophyDrug: Obeticholic Acid;Drug: PlaceboUniversity of Texas Southwestern Medical CenterNULLRecruiting18 Years70 YearsAll20Phase 2United States
15EUCTR2015-000493-35-GR
(EUCTR)
29/02/201604/01/2016Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA 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]
Ionis Pharmaceuticals, Inc.NULLNot 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): noUnited States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2015-000493-35-DE
(EUCTR)
17/02/201614/08/2015Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;Portugal;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands
17EUCTR2015-000493-35-PT
(EUCTR)
15/02/201608/10/2015Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA 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]
Akcea TherapeuticsNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Belgium;Brazil;Netherlands;Germany
18NCT02684591
(ClinicalTrials.gov)
January 201615/1/2016Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and LipodystrophyAramchol Versus Placebo in the Treatment of HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy: A Randomized, Double-blinded, Allocation-concealed, Placebo-controlled Clinical TrialNonalcoholic Fatty Liver Disease;HIVDrug: Aramchol;Drug: PlaceboUniversity of California, San DiegoNULLCompleted18 YearsN/AAll50Phase 2United States
19NCT02639286
(ClinicalTrials.gov)
December 23, 201523/12/2015Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label ExtensionA Randomized, Double Blind, Placebo-Controlled Study to Assess Efficacy, Safety and Tolerability of ISIS 304801 in Patients With Partial Lipodystrophy With an Open-Label ExtensionLipodystrophyDrug: ISIS 304801;Drug: PlaceboNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompleted18 YearsN/AAll5Phase 2United States
20EUCTR2015-000493-35-NL
(EUCTR)
15/12/201530/10/2015Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
125Phase 2/3Portugal;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2015-000493-35-ES
(EUCTR)
04/12/201515/10/2015Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA 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.NULLNot RecruitingFemale: yes
Male: yes
125Phase 2;Phase 3Portugal;United States;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Germany;Netherlands
22EUCTR2015-000493-35-BE
(EUCTR)
09/11/201525/09/2015Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA 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]
Ionis Pharmaceuticals, Inc.NULLNot 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): noUnited States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands
23NCT02527343
(ClinicalTrials.gov)
October 31, 201517/8/2015The BROADEN Study: A Study of Volanesorsen (Formerly ISIS-APOCIIIRx) in Patients With Familial Partial LipodystrophyA Randomized, Double-Blind, Placebo-Controlled, With an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Partial LipodystrophyFamilial Partial LipodystrophyDrug: volanesorsen;Drug: PlaceboIonis Pharmaceuticals, Inc.Akcea TherapeuticsActive, not recruiting18 YearsN/AAll60Phase 2/Phase 3United States;Belgium;Brazil;Canada;Germany;Greece;Israel;Italy;Netherlands;Portugal;Russian Federation;Spain;Turkey;United Kingdom
24NCT02654977
(ClinicalTrials.gov)
September 29, 201520/1/2015CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial LipodystrophyCLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Recombinant Human Leptin (METRELEPTIN) in Various Forms of Partial LipodystrophyFamilial Partial Lipodystrophy;Nonalcoholic Steatohepatitis;NAFLDDrug: MetreleptinUniversity of MichiganNULLCompleted5 YearsN/AAll11Phase 2United States
25NCT03039491
(ClinicalTrials.gov)
September 1, 201530/1/2017Immune Response to Pneumococcal Vaccination in Aging HIV Positive AdultsImmune Response to Pneumococcal Vaccination in Aging HIV Positive IndividualsHIV Lipodystrophy;AgingBiological: Pneumococcal polysaccharide vaccine 23 valent;Biological: 13 valent conjugated pneumococcal vaccineMedical University of South CarolinaNULLCompleted21 Years65 YearsAll160Early Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02492997
(ClinicalTrials.gov)
May 14, 201519/6/2015Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen CircumferenceClinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen CircumferenceLipodystrophyDevice: Venus Versa;Other: Glycerine gelVenus ConceptNULLTerminated18 Years65 YearsAll44N/AUnited States
27NCT02404896
(ClinicalTrials.gov)
January 201520/1/2015Expanded Access Metreleptin StudyExpanded-Access for the Use of Metreleptin in Patients With Partial Lipodystrophy Associated With Diabetes Mellitus or HypertriglyceridemiaFamilial Partial LipodystrophyDrug: MetreleptinUniversity of MichiganNULLActive, not recruiting18 YearsN/AAll11Phase 2United States
28NCT02262806
(ClinicalTrials.gov)
October 14, 20149/10/2014Compassionate Use of Metreleptin in Previously Treated People With Partial LipodystrophyCompassionate Use of Metreleptin in Previously-Treated Patients With Partial LipodystrophyDiabetes;Lipodystrophy;HyperlipidemiaDrug: MetreleptinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLRecruitingN/AN/AAll35Phase 3United States
29NCT02262832
(ClinicalTrials.gov)
October 9, 201410/10/2014Compassionate Use of Metreleptin in Previously Treated People With Generalized LipodystrophyCompassionate Use of Metreleptin in Previously-Treated Patients With Generalized LipodystrophyLipodystrophy;Diabetes;HyperlipidemiaDrug: MetreleptinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLRecruitingN/AN/AAll30Phase 3United States
30NCT02647853
(ClinicalTrials.gov)
October 20143/1/2016Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy VolunteersA Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 GelNasolabial Folds;Lipoatrophy;LipodystrophyDrug: TAT4 Gel concentration A;Drug: TAT4 Gel concentration B;Drug: PlaceboTopokine Therapeutics, Inc.NULLCompleted40 Years70 YearsBoth16Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2013-004539-57-PL
(EUCTR)
30/01/201416/12/2013A 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.NULLNot RecruitingFemale: yes
Male: no
Phase 3Poland
32NCT02056912
(ClinicalTrials.gov)
January 201424/1/2014Identification of a New Gene Involved in Hereditary LipodystrophyIdentification of a New Gene Involved in Hereditary Lipodystrophy - LIPOGENELipodystrophyGenetic: 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 investigationsUniversity Hospital, BordeauxNULLCompleted18 YearsN/ABoth2N/AFrance
33NCT01848340
(ClinicalTrials.gov)
May 20132/5/2013An 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 SubjectsAn 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 SubjectsHIV-associated Lipodystrophy SyndromeDrug: GSK1265744B (sodium salt) containing 14C-GSK1265744B;Drug: 150 mg GSK1265744B;Drug: PlaceboViiV HealthcareGlaxoSmithKlineCompleted18 Years60 YearsBoth16Phase 1United States
34NCT02530827
(ClinicalTrials.gov)
March 20134/8/2015Energy Expenditure of People Living With HIV/AIDSInfluence of Lipid-lowering Drugs in Patients Seropositive for HIV With Lipodystrophy in Resting Energy Expenditure and Total Energy ExpenditureHIV/AIDS;HIV Lipodystrophy SyndromeDrug: use of lipid-lowering drugs.University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloCompleted18 Years60 YearsMale45N/ANULL
35NCT01778556
(ClinicalTrials.gov)
January 26, 201326/1/2013Short-term Effects of Leptin in People With LipodystrophyShort Term Effects of Leptin Withdrawal or Initiation in Lipodystrophy Independent of Energy IntakeLipodystrophyBiological: MetreleptinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompleted14 Years70 YearsAll25Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT01679197
(ClinicalTrials.gov)
October 8, 201231/8/2012Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With LipodystrophyClinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With LipodystrophyFatty Liver Disease, Nonalcoholic;Nonalcoholic Steatohepatitis;LipodystrophyDrug: MetreleptinUniversity of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed5 YearsN/AAll23Phase 2United States
37NCT01788462
(ClinicalTrials.gov)
May 20121/2/2013Egrifta Replacement and Sleep Disordered BreathingEgrifta Replacement and Sleep Disordered BreathingLipodystrophyDrug: Tesamorelin (Egrifta)Johns Hopkins UniversityNULLWithdrawn18 Years75 YearsAll0N/AUnited States
38NCT01612858
(ClinicalTrials.gov)
June 20114/6/2012Metabolic Abnormalities in HIV-infected PersonsMetabolic Abnormalities in HIV-infected PersonsLipodystrophy;HIV InfectionDrug: Metformin;Drug: PioglitazoneTufts Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 Years70 YearsAll20Phase 4United States
39NCT01329744
(ClinicalTrials.gov)
June 20114/4/2011Effects of IGF-I in HIV Metabolic DiseaseEffects of Recombinant IGF-I in HIV Associated Metabolic DiseaseHIV LipodystrophyDrug: mecasermin;Drug: Placebo controlUniversity of Texas Southwestern Medical CenterNULLTerminated18 Years60 YearsBoth16Phase 1United States
40NCT01263717
(ClinicalTrials.gov)
December 201016/12/2010Effects of Growth Hormone Releasing Hormone in HIVEffects of Growth Hormone Releasing Hormone on Fat Redistribution, Cardiovascular Indices, and Growth Hormone Secretion in HIV LipodystrophyHIV;HIV LipodystrophyDrug: tesamorelin;Drug: placeboMassachusetts General HospitalNULLCompleted18 Years65 YearsAll54N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT01164605
(ClinicalTrials.gov)
October 201014/7/2010Pilot Study of Raltegravir Lipodystrophy IISPPilot Study on the Efficacy of a Two Drug, Raltegravir-based Regimen,(NRTI) Sparing Antiretroviral TreatmentHIV InfectionDrug: RaltegravirSouthern California Institute for Research and EducationMerck Sharp & Dohme Corp.RecruitingN/AN/ABoth30N/AUnited States
42JPRN-UMIN000003679
2010/08/0101/06/2010Long-term safety clinical trial of leptin-replacement therapy in patients with lipodystrophy after introduction of the treatment lipodytrophysubcutaneous injection of human recombinant leptinKyoto University HospitalNULLComplete: follow-up complete6years-oldNot applicableMale and Female11Not selectedJapan
43JPRN-UMIN000002818
2010/08/0101/01/2010Phase 2 trial of leptin-replacement therapy for patients with lipodystrophy lipodystrophyadministration of recombinant methionyl human leptinDepartment of Medicine and Clinical Science, Kyoto University Graduate School of MedicineTranslational Research Center, Kyoto University HospitalNULLComplete: follow-up complete6years-oldNot applicableMale and Female3Phase 2Japan
44NCT01023620
(ClinicalTrials.gov)
October 200930/11/2009HIV 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 PresentationsHIV InfectionsDrug: Pioglitazone;Other: ObservationUniversity of Texas Southwestern Medical CenterTakeda Pharmaceuticals North America, Inc.Completed18 YearsN/AMale4N/AUnited States
45NCT01724580
(ClinicalTrials.gov)
June 20095/11/2012Compassionate Use Protocol for the Treatment of Autoinflammatory SyndromesCompassionate 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 DermatomyositisChronic 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: BaricitinibEli Lilly and CompanyNULLNo longer available6 MonthsN/AAllUnited States;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT00795210
(ClinicalTrials.gov)
February 200920/11/2008Effects of Short-term Growth Hormone in HIV-infected PatientsEffects of Short-term Growth Hormone in HIV-infected PatientsHIV LipodystrophyDrug: Growth hormone;Drug: Growth Hormone Releasing HormoneMassachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 Years60 YearsAll25N/AUnited States
47NCT00865007
(ClinicalTrials.gov)
December 200818/3/2009Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With LipoatrophyA 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/RitonavirHIV Infection;Lipodystrophy;HIV InfectionsDrug: Monotherapy (Lopinavir/ritonavir);Drug: Monotherapy (Lopinavir/ritonavir) + ABC/3TCFundacion SEIMC-GESIDAAbbottCompleted18 YearsN/ABoth88Phase 4Spain
48NCT00677313
(ClinicalTrials.gov)
November 200812/5/2008An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With LipodystrophyAn Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With LipodystrophyLipodystrophyDrug: metreleptinBristol-Myers SquibbNULLActive, not recruiting5 YearsN/ABoth41N/AUnited States
49NCT00656175
(ClinicalTrials.gov)
September 20082/4/2008Raltegravir Therapy for Women With HIV and Fat AccumulationPhase II Study of Raltegravir as Replacement for Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Based Antiretroviral Therapy in Women With Fat AccumulationHIV Infections;LipodystrophyDrug: raltegravirUniversity of California, Los AngelesMerck Sharp & Dohme Corp.;Case Western Reserve University;Vanderbilt University;Tufts University;University Health Network, TorontoCompleted18 YearsN/AFemale39Phase 2United States;Canada
50EUCTR2007-003233-16-ES
(EUCTR)
11/12/200722/10/2007A 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.NULLNot RecruitingFemale: yes
Male: yes
300United Kingdom;Belgium;France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2007-003233-16-GB
(EUCTR)
29/11/200702/08/2007A 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
Theratechnologies Inc.NULLNot 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): noFrance;Spain;Belgium;United Kingdom
52EUCTR2007-003233-16-FR
(EUCTR)
19/09/200731/07/2007A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United Kingdom;Belgium;France;Spain
53EUCTR2007-003233-16-BE
(EUCTR)
05/09/200722/08/2007A 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.NULLNot RecruitingFemale: yes
Male: yes
300United Kingdom;Belgium;France;Spain
54NCT00608023
(ClinicalTrials.gov)
August 200723/1/2008TH9507 Extension Study in Patients With HIV- Associated LipodystrophyA 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 AccumulationLipodystrophy;HIV InfectionsDrug: Tesamorelin;Drug: Placebo for TesamorelinTheratechnologiesNULLCompleted18 Years65 YearsAll263Phase 3United States;Belgium;Canada;France;Spain;United Kingdom
55EUCTR2006-005444-88-DE
(EUCTR)
21/06/200714/08/2007A 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 AccumulationA 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.NULLNot RecruitingFemale: yes
Male: yes
400United Kingdom;Germany;France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2006-005444-88-GB
(EUCTR)
08/05/200726/01/2007A 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 AccumulationA 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
Theratechnologies Inc.NULLNot 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): noFrance;Spain;Belgium;Germany;United Kingdom
57EUCTR2006-005444-88-ES
(EUCTR)
25/04/200703/03/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
400Germany;United Kingdom;France;Spain
58EUCTR2006-005444-88-FR
(EUCTR)
15/02/200711/01/2007A 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 AccumulationA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Germany;United Kingdom;France;Spain
59EUCTR2006-005444-88-BE
(EUCTR)
16/01/200721/12/2006A 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 AccumulationA 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.NULLNot RecruitingFemale: yes
Male: yes
400France;Spain;Belgium;Germany;United Kingdom
60NCT00362440
(ClinicalTrials.gov)
August 20069/8/2006Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic SyndromeA Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome: A Randomized, Double-blind, Placebo-controlled Clinical TrialHIV LipodystrophyDrug: Leptin;Drug: Pioglitazone or metformin;Drug: PlaceboBeth Israel Deaconess Medical CenterAmerican Diabetes AssociationCompleted18 YearsN/AAll9Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT00426296
(ClinicalTrials.gov)
August 200623/1/2007SHARE: Simple HAART With Abacavir, Reyataz, and EpivirAn 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 WeeksHIV Infections;LipodystrophyDrug: atazanavir (Reyataz);Drug: ritonavir (Norvir)Clinical Alliance for Research & Education - Infectious Diseases, LLC.GlaxoSmithKlineRecruiting18 YearsN/ABothPhase 4United States
62NCT00896298
(ClinicalTrials.gov)
April 20068/5/2009Trial of Leptin Replacement Therapy in Patients With LipodystrophyDouble-Blind, Placebo-Controlled Trial of Leptin Replacement Therapy in Patients With LipodystrophyHypoleptinemia;Generalized Lipodystrophy;Partial Lipodystrophy;Insulin ResistanceDrug: Leptin;Drug: PlaceboUniversity of Texas Southwestern Medical CenterNULLCompleted6 Years70 YearsAll25Phase 2/Phase 3United States
63NCT00457639
(ClinicalTrials.gov)
April 20064/4/2007Cholic Acid for Hepatic Steatosis in LipodystrophyPhase II Study of Cholic Acid for Hepatic Steatosis in Lipodystrophy PatientsHepatic SteatosisDrug: Cholic AcidUniversity of Texas Southwestern Medical CenterFDA Office of Orphan Products DevelopmentCompleted6 Years70 YearsAll18Phase 2United States
64EUCTR2005-004665-42-IT
(EUCTR)
17/03/200621/04/2006Evaluation 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. - NDEvaluation 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-TAUNULLNot RecruitingFemale: yes
Male: yes
40Italy
65EUCTR2004-002740-10-DE
(EUCTR)
07/11/200504/10/2005A 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 LIPODYSTROPHYA 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 lipodystrophyTrade 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
300Phase 4United Kingdom;Germany;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT00126308
(ClinicalTrials.gov)
November 20051/8/2005Facial Lipoatrophy Trial: Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial LipoatrophyA Multi-Centre, Open-Label, Randomised Study to Assess the Efficacy, Durability and Safety of Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy (FLASH)HIV-Associated Lipodystrophy;HIV InfectionsDevice: poly-L-lactic acidKirby InstituteThe University of New South Wales;Abbott;Bristol-Myers Squibb;Gilead Sciences;GlaxoSmithKline;Merck Sharp & Dohme Corp.;Hoffmann-La Roche;AIDS Council of New South WalesTerminated18 YearsN/ABoth100Phase 4Australia
67EUCTR2005-004021-26-GB
(EUCTR)
06/10/200505/09/2005Longitudinal 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 StudyLongitudinal 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 HIVUniversity Hospital BirminghamNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yesUnited Kingdom
68NCT00656851
(ClinicalTrials.gov)
September 200510/4/2008Myocardial Function & FFA Metabolism in HIV Metabolic SyndromeMyocardial Function, Free Fatty Acid and Glucose Metabolism in HIV Metabolic SyndromeHIV Infections;Cardiovascular Disease;Insulin Resistance;HIV Lipodystrophy;The Metabolic SyndromeDrug: Pioglitazone;Behavioral: Exercise TrainingNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompleted28 Years50 YearsAll24N/AUnited States
69EUCTR2004-002740-10-IT
(EUCTR)
04/07/200524/01/2006A 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.SQUIBBNULLNot RecruitingFemale: yes
Male: yes
300Phase 4Germany;United Kingdom;Spain;Italy
70NCT00135356
(ClinicalTrials.gov)
July 200525/8/2005Study of Reyataz in HIV-infected Patients With Lipodystrophy SyndromeA 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 SyndromeDrug: 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 SquibbNULLCompleted18 YearsN/AAll219Phase 4United States;Canada;France;Germany;Italy;Mexico;Poland;Spain;United Kingdom;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT00123253
(ClinicalTrials.gov)
June 200520/7/2005TH9507 in Patients With HIV-Associated LipodystrophyA 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 AccumulationHIV Infections;LipodystrophyDrug: TH9507TheratechnologiesNULLCompleted18 Years65 YearsBoth412Phase 3United States;Canada
72EUCTR2004-002740-10-ES
(EUCTR)
16/05/200517/05/2006A 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 LIPODYSTROPHYA 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 lipodystrophyTrade 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
300Phase 4Germany;United Kingdom;Spain;Italy
73EUCTR2004-002740-10-GB
(EUCTR)
12/05/200519/04/2005A 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 LIPODYSTROPHYA 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 lipodystrophyTrade 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
300Phase 4Spain;Germany;Italy;United Kingdom
74NCT00119379
(ClinicalTrials.gov)
April 200511/7/2005Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected AdultsReversibility of Mitochondrial Toxicity in HIV LipoatrophyHIV Infections;Lipodystrophy;Metabolic Diseases;Nutrition DisordersDrug: NucleomaxX;Drug: Tenofovir Disoproxil FumarateNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 YearsN/AAll50Phase 2United States
75NCT00130286
(ClinicalTrials.gov)
March 200512/8/2005Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin ResistanceRandomized, 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 ResistanceHIV-Associated Lipodystrophy Syndrome;Insulin Resistance;HIV Infections;Metabolic Syndrome X;Body Weight ChangesDrug: Rosiglitazone;Drug: Recombinant human growth hormone + rosiglitazoneWeill Medical College of Cornell UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 Years65 YearsAll77Phase 1/Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT00119769
(ClinicalTrials.gov)
February 20057/7/2005The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected PatientsThe Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients on Highly Active Antiretroviral Therapy (HAART)HIV Infections;LipodystrophyDrug: Placebo;Drug: Genotropin (human recombinant Growth hormone)Hvidovre University HospitalPfizerCompleted21 Years60 YearsMale46Phase 4Denmark
77NCT00639457
(ClinicalTrials.gov)
January 200518/3/2008Exercise and Pioglitazone for HIV-Metabolic SyndromesExercise and Pioglitazone for HIV-Metabolic SyndromesHIV Infections;Type 2 Diabetes;Obesity;HIV;AIDS;Cardiovascular Disease;LipodystrophyDrug: Pioglitazone;Behavioral: Exercise trainingNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompleted18 Years65 YearsAll44N/AUnited States
78NCT00192621
(ClinicalTrials.gov)
November 200412/9/2005Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy SubjectsA 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 MetabolismHIV Infections;Dyslipidemias;Glucose Metabolism Disorders;Metabolic Diseases;Lipodystrophy;Cardiovascular DiseaseDrug: Combivir (zidovudine [AZT] / lamivudine [3TC]);Drug: Kaletra (lopinavir [LPVr])Kirby InstituteSt Vincent's Hospital, Sydney;National Heart, Lung, and Blood Institute (NHLBI);Garvan Institute of Medical Research;Prince of Wales Hospital, SydneyCompleted18 YearsN/ABoth50Phase 4Australia
79NCT00082628
(ClinicalTrials.gov)
May 200413/5/2004Treatment of Abnormal Adipose Tissue Accumulation in HIV PatientsA 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 HARSHIV Infections;LipodystrophyDrug: Serostim®[somatropin (rDNA origin) for injection]EMD SeronoNULLCompleted18 Years60 YearsBoth569Phase 3United States;Canada
80NCT00139178
(ClinicalTrials.gov)
March 200430/8/2005Switching 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 AbnormalitiesHIV Associated Lipodystrophy Syndrome.;HIV;Hypercholesterolemia;LipoatrophyDrug: Different HAART regimensDanish HIV Research GroupOdense University Hospital;Rigshospitalet, Denmark;Hvidovre University Hospital;Aarhus University HospitalCompleted18 YearsN/ABoth100Phase 4Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT00246376
(ClinicalTrials.gov)
January 200427/10/2005Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or DyslipidemiaDiet/Exercise, Niacin, Fenofibrate for HIV LipodystrophyCardiovascular Diseases;Heart Diseases;HIV Infections;Hyperlipidemia;Hypertriglyceridemia;Insulin Resistance;AtherosclerosisBehavioral: Diet;Behavioral: Exercise;Drug: Niacin;Drug: Fenofibrate;Other: PlacebosBaylor College of MedicineNational Heart, Lung, and Blood Institute (NHLBI);Legacy Community Health CenterCompleted18 Years65 YearsAll221N/AUnited States
82NCT00100698
(ClinicalTrials.gov)
January 20044/1/2005Physiologic Growth Hormone Effects in HIV LipodystrophyPhysiologic Growth Hormone Effects in HIV LipodystrophyAIDS;HIV InfectionsDrug: recombinant human growth hormone;Drug: placeboMassachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 Years60 YearsAll56N/AUnited States
83NCT00122668
(ClinicalTrials.gov)
November 200321/7/2005Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive PatientsRandomized 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 SyndromeDrug: non-nucleoside reverse transcriptase inhibitors;Drug: nucleoside reverse transcriptase inhibitors;Drug: protease inhibitorFrench National Agency for Research on AIDS and Viral HepatitisNULLTerminated18 YearsN/ABoth112Phase 4France
84NCT00135460
(ClinicalTrials.gov)
June 200325/8/2005Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected PatientsComparing 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 SyndromeDrug: nucleoside analogue sparing HAART regimenDanish HIV Research GroupRigshospitalet, Denmark;Hvidovre University Hospital;Odense University Hospital;Aarhus University Hospital;Aalborg Universitetshospital;AbbottActive, not recruiting18 YearsN/ABoth100Phase 4Denmark
85NCT00647946
(ClinicalTrials.gov)
February 200327/3/2008Study to Evaluate Changes in Limb Fat When Switching From a Thymidine AnalogueA 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)LipodystrophyDrug: tenofovir DF;Drug: abacavir 300mg twice dailyGilead SciencesNULLCompleted18 YearsN/ABoth100Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT00192660
(ClinicalTrials.gov)
February 200312/9/2005HIV 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 TimeHIV-Associated Lipodystrophy Syndrome;Cardiovascular DiseaseDrug: 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 InstituteSt Vincent's Hospital, Sydney;National Heart, Lung, and Blood Institute (NHLBI)Completed18 YearsN/ABoth80Phase 4Australia
87NCT01511016
(ClinicalTrials.gov)
February 200311/1/2012Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy SyndromeThe Effect of Leptin Therapy on Abnormal Lipid Kinetics in Subjects With HIV Lipodystrophy SyndromeHIV LipodystrophyDrug: Human recombinant leptin (metreleptin);Drug: PlaceboBaylor College of MedicineNULLCompleted18 Years64 YearsMale17N/AUnited States
88NCT00148850
(ClinicalTrials.gov)
February 20037/9/2005Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 PatientsA 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 StudyHIV-Associated Lipodystrophy Syndrome;HIV InfectionsDrug: PioglitazoneFrench National Agency for Research on AIDS and Viral HepatitisTakedaTerminated18 YearsN/ABoth130Phase 3France
89NCT00122226
(ClinicalTrials.gov)
January 200314/7/2005MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)HIV Infections;HIV-Associated Lipodystrophy SyndromeDrug: Lopinavir/ritonavir + zidovudine + lamivudine;Drug: Lopinavir/ritonavir + nevirapineVU University Medical CenterAbbott;Boehringer IngelheimActive, not recruiting18 Years70 YearsMale50Phase 4Finland;Netherlands;Spain;United Kingdom
90NCT00461552
(ClinicalTrials.gov)
January 200316/4/2007Therapeutic Approaches to HAART-Induced LipodystrophyTherapeutic Approaches to HAART-Induced LipodystrophyHIV Infections;LipodystrophyDrug: Leptin;Other: PlaceboUniversity of Texas Southwestern Medical CenterAmylin Pharmaceuticals, LLC.Completed14 Years65 YearsAll23Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT00246402
(ClinicalTrials.gov)
September 200227/10/2005Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIVAnti-Lipolytic Strategy for HIV LipodystrophyInsulin Resistance;Cardiovascular Diseases;Heart Diseases;HIV Infections;Hypertriglyceridemia;HyperlipidemiaDrug: AcipimoxNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted18 Years65 YearsBoth30N/AUnited States
92NCT00006412
(ClinicalTrials.gov)
July 200213/10/2000Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood LipidsA Prospective, Multicenter, Randomized Trial Comparing the Efficacy and Safety of Fenofibrate Versus Pravastatin in HIV-Infected Subjects With Lipid AbnormalitiesHIV Infections;LipodystrophyDrug: Pravastatin sodium;Drug: FenofibrateNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 YearsN/ABoth630Phase 3United States;Puerto Rico
93NCT00202228
(ClinicalTrials.gov)
July 200213/9/2005Lactate Metabolism Study in HIV Infected PersonsLactic 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;LipodystrophyDrug: cofactor supplementation (thiamine, riboflavin, L-carnitine)Queen's UniversityOntario HIV Treatment NetworkCompleted18 YearsN/ABoth30Phase 4Canada
94NCT00028314
(ClinicalTrials.gov)
March 200220/12/2001Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV PatientsA 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 WastingHIV Infections;Lipodystrophy;Wasting DiseaseDrug: Abacavir sulfate;Drug: Atazanavir/Ritonavir;Drug: Lopinavir/Ritonavir;Drug: NevirapineNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted13 YearsN/ABoth150N/AUnited States
95NCT00457665
(ClinicalTrials.gov)
February 20024/4/2007Mechanisms of Lipodystrophy in HIV-Infected PateintsMecahnisms of Lipodystrophy in HIV-Infected PatientsHIV InfectionsDrug: Nelfinavir;Drug: EfavirenzUniversity of Texas Southwestern Medical CenterBristol-Myers Squibb;GlaxoSmithKlineCompleted18 Years70 YearsAll56Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT00646984
(ClinicalTrials.gov)
January 200226/3/2008Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With LipodystrophyComparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy.HIV-Associated Lipodystrophy SyndromeDrug: Standard continuous antiretroviral therapy;Drug: CD-4 guided therapy interruption;Drug: Viral load driven treatment interruptionHospital Clinic of BarcelonaNULLCompleted18 YearsN/ABoth147Phase 4Spain
97NCT00140244
(ClinicalTrials.gov)
December 200130/8/2005Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic SyndromeRole of Leptin in Highly Active Antiretroviral Therapy (HAART)-Induced Lipodystrophy and Metabolic Syndrome in HAART-Treated HIV PatientsHAART-induced Lipodystrophy and Metabolic SyndromeDrug: r-metHuLeptin;Drug: PlaceboBeth Israel Deaconess Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);AmgenCompleted18 YearsN/AAll7Phase 2United States
98NCT00025883
(ClinicalTrials.gov)
October 200127/10/2001Leptin to Treat LipodystrophyLong-Term Efficacy of Leptin Replacement in Treatment of LipodystrophyLipodystrophyDrug: MetreleptinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompleted6 MonthsN/AAll103Phase 2United States
99NCT00227500
(ClinicalTrials.gov)
July 200127/9/2005Pravastatin for Hyperlipidaemia in HIV.A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIVHIV Infections;Lipid Metabolism;Glucose Metabolism;Metabolic Abnormality;Lipodystrophy;Cardiovascular DiseaseDrug: PravastatinKirby InstituteThe University of New South Wales;National Heart, Lung, and Blood Institute (NHLBI);Garvan Institute of Medical Research;St Vincent's Hospital, SydneyCompleted18 YearsN/ABoth40Phase 4Australia
100NCT00017758
(ClinicalTrials.gov)
June 200111/6/2001The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering DrugsThe Effect of Efavirenz and Nelfinavir on the Pharmacokinetics of Hydroxymethylglutaryl Coenzyme A Reductase InhibitorsHIV Infections;HIV Seronegativity;LipodystrophyDrug: Pravastatin sodium;Drug: Simvastatin;Drug: Atorvastatin calcium;Drug: Nelfinavir mesylate;Drug: EfavirenzNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years60 YearsBoth56Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT00021463
(ClinicalTrials.gov)
April 200114/7/2001Changing to Nonprotease Inhibitor Treatment to Improve Side EffectsPhase II, Randomized, Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic AbnormalitiesHIV Infections;LipodystrophyDrug: Abacavir sulfate, Lamivudine and Zidovudine;Drug: Abacavir sulfate;Drug: Efavirenz;Drug: NevirapineNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted13 YearsN/ABoth342Phase 2United States
102NCT00015691
(ClinicalTrials.gov)
April 20011/5/2001Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients With Insulin and Fat AbnormalitiesA Randomized, Double-Blind, Placebo-Controlled Study of Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Subjects With Hyperinsulinemia and Elevated Waist/Hip RatioHIV Infections;Lipodystrophy;HyperinsulinemiaDrug: Metformin hydrochloride;Drug: Rosiglitazone maleateNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years65 YearsBoth105N/AUnited States
103NCT00122655
(ClinicalTrials.gov)
January 200121/7/2005Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With LipoatrophyA Randomized Prospective Study Evaluating the Impact on Fat Distribution of NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy ANRS 108 NONUKE StudyHIV Infections;HIV Lipodystrophy SyndromeDrug: non-nucleoside reverse transcriptase inhibitors;Drug: nucleoside reverse transcriptase inhibitors;Drug: protease inhibitorsFrench National Agency for Research on AIDS and Viral HepatitisNULLTerminated18 YearsN/ABoth100Phase 4France
104NCT00006190
(ClinicalTrials.gov)
November 200025/8/2000A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop LipodystrophyThe Study of Mechanisms of Lipodystrophy in HIV-Infected PatientsHIV Infections;LipodystrophyDrug: Nelfinavir mesylate;Drug: Stavudine;Drug: Lamivudine;Drug: EfavirenzNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompleted18 Years70 YearsBothPhase 4United States
105NCT00005905
(ClinicalTrials.gov)
June 20009/6/2000Leptin to Treat LipodystrophyEfficacy of Leptin Replacement in Treatment of LipodystrophyLipodystrophyDrug: hu Leptin (A-100)National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompletedN/AN/ABoth20Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT00005764
(ClinicalTrials.gov)
May 200030/5/2000A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive PatientsGlaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)HIV Infections;LipodystrophyDrug: Lamivudine/Zidovudine;Drug: Abacavir sulfate;Drug: LamivudineGlaxo WellcomeNULLCompleted18 YearsN/ABoth100Phase 4United States
107NCT00202241
(ClinicalTrials.gov)
September 199913/9/2005The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDSThe Effects of Anabolic Steroids and Protease Inhibitors on Serum Blood Lipids,Muscle Mass, and Total Body Fat in People Living With HIV/AIDSHIV;AIDS;Lipodystrophy;HyperlipidemiaProcedure: testosterone injectionQueen's UniversityOntario Ministry of Health and Long Term CareCompleted18 YearsN/ABoth30N/ACanada
108NCT00006185
(ClinicalTrials.gov)
September 199922/8/2000Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy SyndromeCellular Mechanisms for Metabolic Dysfunction in HIVHIV Infections;Lipodystrophy;Insulin ResistanceDrug: Avandia administration for 6-12 weeksNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompleted18 Years55 YearsBothPhase 1United States
109NCT00002417
(ClinicalTrials.gov)
March 19982/11/1999A Study of Amprenavir in Patients With Protease Inhibitor-Related ComplicationsAn 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 TherapyHIV InfectionsDrug: AmprenavirGlaxo WellcomeNULLCompleted13 YearsN/ABothN/AUnited States