At a glance
ClinicalIndex Comparison Record- ✓HIV-infected and on stable FDA-approved antiretrovirals for at least 8 weeks
- ✓Excess abdominal fat measured by waist circumference and waist-to-hip ratio
- ✓Evidence of insulin resistance based on fasting glucose and insulin levels
- ✓Triglycerides less than 750 mg/dL
- ✕Pregnancy
- ✕Active AIDS-defining infection or other acute illness within 30 days of entry
- ✕Active cancer (except localized Kaposi's sarcoma) or active brain tumor
- ✕History of pancreatitis, carpal tunnel syndrome, diabetes, angina, coronary artery disease, or disorders associated with fluid retention
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Recombinant Human Growth Hormone and/or Rosiglitazone in the Treatment of Human Immunodeficiency Virus-Associated Visceral Adiposity and Insulin Resistance
In Brief
A Phase 2 clinical trial evaluating Rosiglitazone and Recombinant human growth hormone + rosiglitazone for HIV-Associated Lipodystrophy Syndrome and 4 related conditions. Completed, enrolled 77 participants across 4 sites.
Detailed Summary
The purpose of the study is to determine if the combination of recombinant human growth hormone plus rosiglitazone (an insulin-sensitizing drug) is safe and more effective than either drug alone (or no active therapy) for the treatment of fat accumulation in people with HIV infection and insulin resistance.
Study Details
Timeline
Interventions
4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)