↑ 疾患リストへ ← 戻る

 265. 脂肪萎縮症 [臨床試験数:88,薬物数:132(DrugBank:54),標的遺伝子数:14,標的パスウェイ数:78] 

Searched query = "Lipodystrophy", "Berardinelli-Seip syndrome", "Lawrence syndrome", "Barraquer-Simons syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03900286July 16, 201915 July 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 TrustNot recruiting18 Years99 YearsAll20N/A
2NCT03936829April 28, 20193 June 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 UniversityRecruitingN/AN/AAll10N/AChina
3NCT04026178November 14, 201829 July 2019Immunogenicity 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.Recruiting1 YearN/AAll10Phase 4United States
4EUCTR2017-003014-22-AT25/06/201823 July 2018Leptin in hepatic lipid metabolism in humansThe role of leptin in regulating hepatic lipid metabolism in humans - Leptin and hepatic lipid metabolismlipodystrophy patients, patients after liver transplantation and healthy controls;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Trade Name: Myalept
Product Name: Myalept
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: metrelpetin
Current Sponsor code: Thalamus_V2
Other descriptive name: METRELEPTIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Medical University of ViennaAuthorisedFemale: yes
Male: yes
43Phase 2Austria
5NCT03514420May 30, 201830 September 2019Study 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.Not recruiting18 YearsN/AAll4Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03508687March 13, 201826 August 2019Study 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 OralNot recruiting18 YearsN/AAll5Phase 1/Phase 2United States
7NCT03226821February 7, 201811 June 2018Body 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
8NCT03262610November 17, 201727 August 2018Setemelanotide 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.Not recruiting15 Years15 YearsFemaleN/AUnited States
9NCT02430077June 20167 October 2019Phase 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 CenterRecruiting18 Years70 YearsAll20Phase 2United States
10EUCTR2015-000493-35-DE17/02/201628 May 2018Study 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 StudyPartial 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ISIS 304801
CAS Number: 915430-78-3
Current Sponsor code: ISIS 304801
Other descriptive name: ISIS 304801
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Akcea TherapeuticsAuthorisedFemale: yes
Male: yes
60Phase 3Portugal;United States;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02684591January 201626 August 2019Aramchol 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 DiegoNot recruiting18 YearsN/AAll50Phase 2United States
12NCT02639286December 23, 201514 October 2019Efficacy, 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)Not recruiting18 YearsN/AAll6Phase 2United States
13NCT02527343October 31, 20153 September 2018The 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 TherapeuticsNot recruiting18 YearsN/AAll60Phase 2/Phase 3United States;Belgium;Brazil;Canada;Germany;Greece;Israel;Italy;Netherlands;Portugal;Russian Federation;Spain;Turkey;United Kingdom
14NCT03039491September 1, 201529 April 2019Immune 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 CarolinaRecruiting21 Years65 YearsAll160Early Phase 1United States
15NCT02492997May 201516 December 2017Clinical 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 ConceptNot recruiting18 Years65 YearsAll44N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02654977April 20154 November 2019CLINICAL 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 MichiganNot recruiting5 YearsN/AAll11Phase 2United States
17NCT02404896January 201525 February 2019Expanded Access Metreleptin StudyExpanded-Access for the Use of Metreleptin in Patients With Partial Lipodystrophy Associated With Diabetes Mellitus or HypertriglyceridemiaFamilial Partial LipodystrophyDrug: MetreleptinUniversity of MichiganNot recruiting18 YearsN/AAll11Phase 2United States
18NCT02262806October 14, 201411 November 2019Compassionate 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)RecruitingN/AN/AAll35Phase 3United States
19NCT02262832October 9, 201411 November 2019Compassionate 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)RecruitingN/AN/AAll30Phase 3United States
20NCT02647853October 201418 January 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.Not recruiting40 Years70 YearsBoth16Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2013-004539-57-PL30/01/201410 July 2015A 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 Level: LLT 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: diosmin
CAS Number: 520-27-4
Other descriptive name: DIOSMIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
ALIO MEDICA Sp. z o.o.Not RecruitingFemale: yes
Male: no
Phase 3Poland
22NCT02056912January 201419 February 2015Identification 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, BordeauxNot recruiting18 YearsN/ABoth2N/AFrance
23NCT01848340May 201319 February 2015An 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 HealthcareGlaxoSmithKlineNot recruiting18 Years60 YearsBoth16Phase 1United States
24NCT02530827March 201331 August 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 PauloNot recruiting18 Years60 YearsMale45N/A
25NCT01778556January 26, 201311 March 2019Short-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)Not recruiting14 Years70 YearsAll27Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01724580October 25, 201217 September 2018Compassionate 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 CompanyNot recruiting6 MonthsN/AAllPhase 1United States;United Kingdom
27NCT01679197October 8, 201216 December 2017Clinical 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)Not recruiting5 YearsN/AAll23Phase 2United States
28NCT01788462May 201216 December 2017Egrifta Replacement and Sleep Disordered BreathingEgrifta Replacement and Sleep Disordered BreathingLipodystrophyDrug: Tesamorelin (Egrifta)Johns Hopkins UniversityNot recruiting18 Years75 YearsAll0N/AUnited States
29NCT01329744June 201111 April 2016Effects 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 CenterNot recruiting18 Years60 YearsBoth16Phase 1United States
30NCT01612858June 201119 October 2017Metabolic 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)Not recruiting18 Years70 YearsAll20Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT01263717December 201016 December 2017Effects 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 HospitalNot recruiting18 Years65 YearsAll54N/AUnited States
32NCT01164605October 201019 February 2015Pilot 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
33JPRN-UMIN0000028182010/08/012 April 2019Phase 2 trial of leptin-replacement therapy for patients with lipodystrophylipodystrophyadministration of recombinant methionyl human leptinDepartment of Medicine and Clinical Science, Kyoto University Graduate School of Medicine Translational Research Center, Kyoto University HospitalNot Recruiting6years-oldNot applicableMale and Female3Not selectedJapan
34JPRN-UMIN0000036792010/08/012 April 2019Long-term safety clinical trial of leptin-replacement therapy in patients with lipodystrophy after introduction of the treatmentlipodytrophysubcutaneous injection of human recombinant leptinKyoto University HospitalNot Recruiting6years-oldNot applicableMale and Female11Not selectedJapan
35NCT01023620October 200919 February 2015HIV 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.Recruiting18 YearsN/AMale24N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT00795210February 200919 October 2017Effects 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)Not recruiting18 Years60 YearsAll25N/AUnited States
37NCT00677313November 200819 February 2015An 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 SquibbNot recruiting5 YearsN/ABoth41N/AUnited States
38NCT00656175September 200819 October 2017Raltegravir 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, TorontoNot recruiting18 YearsN/AFemale39Phase 2United States;Canada
39EUCTR2007-003233-16-FR19/09/200726 June 2012A 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
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Tesamorelin
CAS Number: 218949-48-5
Current Sponsor code: TH9507
Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.1-
Pharmaceutical form of the placebo: Powder and solvent for suspension for injection
Route of administration of the placebo: Subcutaneous use
Theratechnologies Inc.AuthorisedFemale: yes
Male: yes
300United Kingdom;Belgium;France;Spain
40NCT00608023August 200719 October 2017TH9507 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 TesamorelinTheratechnologiesNot recruiting18 Years65 YearsAll263Phase 3United States;Belgium;Canada;France;Spain;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2006-005444-88-BE16/01/20077 October 2014A 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 AccumulationHIV-associated lipodystrophy
MedDRA version: 8.1 Level: LLT Classification code 10024608 Term: Lipodystrophy
Product Name: TH9507
Product Code: TH9507
Pharmaceutical Form: Powder and solvent for suspension for injection
CAS Number: 218949-48-5
Current Sponsor code: TH9507
Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.1-
Pharmaceutical form of the placebo: Powder and solvent for suspension for injection
Route of administration of the placebo: Subcutaneous use
Theratechnologies Inc.Not RecruitingFemale: yes
Male: yes
400France;Spain;Belgium;Germany;United Kingdom
42NCT00362440August 200616 December 2017Combination 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 AssociationNot recruiting18 YearsN/AAll9Phase 2United States
43NCT00426296August 200619 February 2015SHARE: 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
44NCT00457639April 200628 January 2019Cholic 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 DevelopmentNot recruiting6 Years70 YearsAll18Phase 2United States
45NCT00896298April 200611 March 2019Trial 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 CenterNot recruiting6 Years70 YearsAll25Phase 2/Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2005-004665-42-IT17/03/200619 March 2012Evaluation 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. - NDHIV related LIPODYSTROPHY.
MedDRA version: 6.1 Level: PT Classification code 10061624
Product Name: ACETYL- L- CARNITINE
Product Code: ST200
Pharmaceutical Form: Granules for oral solution
INN or Proposed INN: Acetylcarnitine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Granules for oral solution
Route of administration of the placebo: Oral use
SIGMA-TAUNot RecruitingFemale: yes
Male: yes
40Italy
47NCT00126308November 200519 February 2015Facial 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 WalesNot recruiting18 YearsN/ABoth100Phase 4Australia
48EUCTR2005-004021-26-GB06/10/200518 April 2012Longitudinal 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 StudyHIVTrade Name: SUSTIVA
Product Name: Efavirenz
Pharmaceutical Form: Capsule*
Trade Name: COMBIVIR
Product Name: AZT/3TC
Pharmaceutical Form: Tablet
Trade Name: TRUVADA
Product Name: emtricitabine/tenofovir
Pharmaceutical Form: Film-coated tablet
University Hospital BirminghamAuthorisedFemale: yes
Male: yes
United Kingdom
49NCT00656851September 200519 October 2017Myocardial 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)Not recruiting28 Years50 YearsAll24N/AUnited States
50NCT00135356July 200519 October 2017Study 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 SquibbNot recruiting18 YearsN/AAll219Phase 4United States;Canada;France;Germany;Italy;Mexico;Poland;Spain;United Kingdom;Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT00123253June 200519 February 2015TH9507 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: TH9507TheratechnologiesNot recruiting18 Years65 YearsBoth412Phase 3United States;Canada
52EUCTR2004-002740-10-GB12/05/20051 May 2012A 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, and Revised 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, and Revised Protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHYHIV-infected individuals with lipodystrophyTrade Name: Reyataz
Product Name: Reyataz
Product Code: BMS-232632
Pharmaceutical Form: Capsule*
INN or Proposed INN: Atazanavir
CAS Number: 229975-97-7
Current Sponsor code: BMS-232632
Other descriptive name: ATV
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: Norvir
Product Name: Norvir
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ritonavir
CAS Number: 155213-67-5
Other descriptive name: RTV
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Bristol-Myers Squibb International CorporationAuthorisedFemale: yes
Male: yes
300Phase 4Germany;United Kingdom;Spain;Italy
53NCT00119379April 200516 December 2017Effectiveness 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)Not recruiting18 YearsN/AAll50Phase 2United States
54NCT00130286March 200519 October 2017Growth 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)Not recruiting18 Years65 YearsAll77Phase 1/Phase 2United States
55NCT00119769February 200519 February 2015The 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 HospitalPfizerNot recruiting21 Years60 YearsMale46Phase 4Denmark
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT00639457January 200519 October 2017Exercise 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)Not recruiting18 Years65 YearsAll44N/AUnited States
57NCT00192621November 200419 February 2015Seronegatives 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, SydneyNot recruiting18 YearsN/ABoth50Phase 4Australia
58NCT00082628May 200419 February 2015Treatment 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 SeronoNot recruiting18 Years60 YearsBoth569Phase 3United States;Canada
59NCT00139178March 200419 February 2015Switching 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 HospitalNot recruiting18 YearsN/ABoth100Phase 4Denmark
60NCT00100698January 200419 October 2017Physiologic 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)Not recruiting18 Years60 YearsAll56N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT00246376January 200419 October 2017Diet, 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 CenterNot recruiting18 Years65 YearsAll221N/AUnited States
62NCT00122668November 200319 February 2015Evaluation 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 HepatitisNot recruiting18 YearsN/ABoth112Phase 4France
63NCT00135460June 200319 February 2015Comparing 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;AbbottNot recruiting18 YearsN/ABoth100Phase 4Denmark
64NCT00148850February 200319 February 2015Effect 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 HepatitisTakedaNot recruiting18 YearsN/ABoth130Phase 3France
65NCT00192660February 200319 February 2015HIV 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)Not recruiting18 YearsN/ABoth80Phase 4Australia
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT00647946February 200319 February 2015Study 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 SciencesNot recruiting18 YearsN/ABoth100Phase 2United Kingdom
67NCT01511016February 200319 October 2017Leptin 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 MedicineNot recruiting18 Years64 YearsMale17N/AUnited States
68NCT00122226January 200319 February 2015MEDICLAS 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 IngelheimNot recruiting18 Years70 YearsMale50Phase 4Finland;Netherlands;Spain;United Kingdom
69NCT00461552January 200320 May 2019Therapeutic Approaches to HAART-Induced LipodystrophyTherapeutic Approaches to HAART-Induced LipodystrophyHIV Infections;LipodystrophyDrug: Leptin;Other: PlaceboUniversity of Texas Southwestern Medical CenterAmylin Pharmaceuticals, LLC.Not recruiting14 Years65 YearsAll23Phase 2United States
70NCT00246402September 200219 February 2015Acipimox 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)Not recruiting18 Years65 YearsBoth30N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT00006412July 200219 February 2015Safety 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)Not recruiting18 YearsN/ABoth630Phase 3United States;Puerto Rico
72NCT00202228July 200225 January 2016Lactate 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 NetworkNot recruiting18 YearsN/ABoth30Phase 4Canada
73NCT00028314March 200219 February 2015Effects 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)Not recruiting13 YearsN/ABoth150N/AUnited States
74NCT00457665February 20028 June 2015Mechanisms of Lipodystrophy in HIV-Infected PateintsMecahnisms of Lipodystrophy in HIV-Infected PatientsHIV InfectionsDrug: Viracept versus Sustiva with stavudine and epivirUniversity of Texas Southwestern Medical CenterBristol-Myers Squibb;GlaxoSmithKlineNot recruiting18 Years70 YearsBoth200Phase 4United States
75NCT00646984January 200219 February 2015Strategies 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 BarcelonaNot recruiting18 YearsN/ABoth147Phase 4Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT00140244December 200116 December 2017Randomized, 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);AmgenNot recruiting18 YearsN/AAll7Phase 2United States
77NCT00025883October 200119 October 2017Leptin to Treat LipodystrophyLong-Term Efficacy of Leptin Replacement in Treatment of LipodystrophyLipodystrophyDrug: MetreleptinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruiting6 MonthsN/AAll103Phase 2United States
78NCT00227500July 200119 February 2015Pravastatin 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, SydneyNot recruiting18 YearsN/ABoth40Phase 4Australia
79NCT00017758June 200119 February 2015The 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)Not recruiting18 Years60 YearsBoth56Phase 1United States
80NCT00015691April 200119 February 2015Metformin 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)Not recruiting18 Years65 YearsBoth105N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT00021463April 200119 February 2015Changing 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)Not recruiting13 YearsN/ABoth342Phase 2United States
82NCT00122655January 200119 February 2015Study 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 HepatitisNot recruiting18 YearsN/ABoth100Phase 4France
83NCT00006190November 200019 February 2015A 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)Not recruiting18 Years70 YearsBothPhase 4United States
84NCT00005905June 200019 February 2015Leptin to Treat LipodystrophyEfficacy of Leptin Replacement in Treatment of LipodystrophyLipodystrophyDrug: hu Leptin (A-100)National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruitingN/AN/ABoth20Phase 2United States
85NCT00005764May 200019 February 2015A 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 WellcomeNot recruiting18 YearsN/ABoth100Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT00006185September 199919 February 2015Underlying 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)Not recruiting18 Years55 YearsBothPhase 1United States
87NCT00202241September 199925 January 2016The 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 CareNot recruiting18 YearsN/ABoth30N/ACanada
88NCT00002417March 199819 February 2015A 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 WellcomeNot recruiting13 YearsN/ABothN/AUnited States

先頭へ