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
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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
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 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
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
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=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 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
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=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 2 N=14 Therapeutic Approaches to HAART-Induced Lipodystrophy
HIV Infections · Lipodystrophy
Primary: Fasting Serum Triglycerides — 237; 341 mg/dL — p=0.84
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 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
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 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 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
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 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
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
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=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
N/A N=10 Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane
Atrophy
Primary: Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting — -28.1 mm
Phase 2 N=39 Raltegravir Therapy for Women With HIV and Fat Accumulation
HIV Infections · Lipodystrophy
Primary: Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2) — -6.6; 1.8 cm^2 — p=0.52
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=60 Tesamorelin Effects on Liver Fat and Histology in HIV
Human Immunodeficiency Virus (HIV) · Nonalcoholic Fatty Liver Disease (NAFLD) · Nonalcoholic Steatohepatitis (NASH)
Primary: Change in Liver Fat as Measured by 1-H Magnetic Resonance Spectroscopy — -4.7; 0.0 percent (hepatic fat fraction)
N/A N=56 Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications
HIV Infections
Primary: Change in Mitochondrial Activity — 1250; 1312; 1150; 1125 copies/cell
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
Phase 4 N=92 TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada
HIV Infections
Primary: Change From Baseline to Week 12 in Fasting Triglycerides — -0.5; -0.1 mmol/L — p=0.034
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
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