Phase 4 N=56 Mechanisms of Lipodystrophy in HIV-Infected Pateints
HIV Infections
Primary: Effect of Drug Regimens on Serum Triglycerides. — 228.0; 230.4; 293.4; 290.0 mg/dL — p=0.94
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=4 HIV Acquired Lipodystrophy (HAL) Classification, Measurement and Fat Response to Thiazolidinedione (TZD) (Pioglitazone)
HIV Infections
Primary: Percent of Liver Fat Pre/Post Challenge With Daily Pioglitazone 45 mg
N/A N=17 Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome
HIV Lipodystrophy
Primary: Rate of Total Lipolysis — 0.649; 0.767 mmol FFA/kg/h
Phase 4 N=200 Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
HIV-Associated Lipodystrophy Syndrome
Primary: Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48 — 0.02; -0.02; 0.02; -0.01 ratio — p=0.48
Phase 2 N=9 Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome
HIV Lipodystrophy
Primary: Insulin Resistance (HOMA Index) — 1.6; 1.8 units on a scale
Phase 4 N=20 Metabolic Abnormalities in HIV-infected Persons
Lipodystrophy · HIV Infection
Primary: Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent — -0.25; -0.96 mg/kg lean body mass/min
Phase 4 N=80 Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada
HIV-1
Primary: Change From Baseline in Limb Fat at Week 48 — 392; -257 grams (g) — p=0.0014
Phase 2 N=14 Therapeutic Approaches to HAART-Induced Lipodystrophy
HIV Infections · Lipodystrophy
Primary: Fasting Serum Triglycerides — 237; 341 mg/dL — p=0.84
Phase 2 N=7 Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
HAART-induced Lipodystrophy and Metabolic Syndrome
Primary: Serum Lipid Levels — 228.8; 219.7; 113.0; 105.7 mg/dl
Phase 3 N=326 Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients
HIV Infections · Lipodystrophy
Primary: Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12 — 0.5; -32.6 Square Centimeter (cm^2) — p=<0.001
N/A N=56 Physiologic Growth Hormone Effects in HIV Lipodystrophy
AIDS · HIV Infections
Primary: Change in Visceral Adipose Tissue Area From Baseline to 18 Months — -22; -4 centimeters squared — p=0.049
N/A N=346 A Comparison of Body Fat Distribution in HIV-1 Infected Patients Receiving, Since the Beginning and for at Least Two Years, an Antiretroviral Therapy Based on Efavirenz or Lopinavir/Ritonavir Combined With Tenofovir + Emtricitabine or Lamivudine
HIV Infection
Primary: Total Limb Fat Mass — 8.84; 9.13 kg
Phase 2 N=50 Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults
HIV Infections · Lipodystrophy · Metabolic Diseases
Primary: Change in Fat mtDNA Content — -169; 321 copies/cell
Phase 3 N=263 TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Lipodystrophy · HIV Infections
Primary: Changes From Baseline in Fasting Blood Glucose at Week 52 — 0; -2; 1 mg/dL — p=>0.05
N/A N=18 Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
HIV Infections · Lipodystrophy · Metabolic Diseases
Primary: Mitochondrial Function (mtDNA Levels) — 1372 copies per cell
Phase 2 N=71 Rosiglitazone Effect on Mitochondria and Lipoatrophy
HIV Infections
Primary: Change in Limb Fat at 48 Weeks — 448; 153 grams — p=0.02
Phase 3 N=165 Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy
HIV Infections · Lipoatrophy
Primary: Change in Limb Fat (g) From Baseline — 74; 110 grams — p=0.64
Phase 2 N=36 HIV and Fat Accumulation
HIV Infection
Primary: Median Change in Visceral Adipose Tissue (VAT) Volume — -4.6 cm^2
Phase 2 N=103 Leptin to Treat Lipodystrophy
Lipodystrophy
Primary: Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin — 8.4; 8.1; 6.6; 7.2 percentage of glycated hemoglobin — p=<0.001
N/A N=50 Lifestyle Modification and Metformin Use in the Treatment of HIV
HIV Infections · Metabolic Syndrome X
Primary: Carotid Intima Media Thickness — -0.02; -0.02; 0.00; 0.03 mm — p=0.37
N/A N=24 Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome
HIV Infections · Cardiovascular Disease · Insulin Resistance
Primary: Myocardial Glucose Utilization Rate — 109.6; 106.7; 109.1; 87.2 (nmol glucose/g heart muscle/min
N/A N=328 Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters
HIV Infection
Primary: Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT) — 8.2; 10.7; 12.9 micron/year — p=0.013
N/A N=46 Eplerenone in HIV Associated Abdominal Fat Accumulation
HIV
Primary: Insulin Stimulated Glucose Uptake — 7.70; 8.58 mg/min per μIU/ml — p=0.71
N/A N=5 HIV Posterior Cheek Enlargement
HIV Posterior Cheek Enlargement
Primary: Percentage Change in Volume of the Masseter Muscle From Baseline to 12 Weeks After Treatment With Botulinum Toxin A — 21.4 percentage reduction in masseter volume
Phase 3 N=25 Trial of Leptin Replacement Therapy in Patients With Lipodystrophy
Hypoleptinemia · Generalized Lipodystrophy · Partial Lipodystrophy
Primary: Fasting Serum Triglycerides — 203; 304 mg/dL — p=0.2572
N/A N=221 Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia
Cardiovascular Diseases · Heart Diseases · HIV Infections
Primary: Triglycerides — 199; 216.9; 155.1; 177.6 mg/dL
Phase 2 N=5 Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension
Lipodystrophy
Primary: Change in Log 10 Fasting Triglycerides. — 0.1; -0.2 log 10 mg/dl
N/A N=215 Incidence of HANA Conditions in HIV-infected Individuals
HIV · Metabolic Syndrome · Osteopenia
Primary: Prevalences of HIV-associated Non-AIDS Conditions (HANA) — 69; 15; 30; 4 Participants — p=0.244
N/A N=44 Exercise and Pioglitazone for HIV-Metabolic Syndromes
HIV Infections · Type 2 Diabetes · Obesity
Primary: Insulin-stimulated Glucose Disposal Rate — 30; 34; 37; 48 µmol glucose/kg FFM/min
Phase 2 N=77 Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
HIV-Associated Lipodystrophy Syndrome · Insulin Resistance · HIV Infections
Primary: Change in Insulin Sensitivity — 0.20; 1.44; -0.63; 0.14 uU*10^-4*min*ml^-1