At a glance
ClinicalIndex Comparison Record- ✓Documented HIV infection by PCR/bDNA/p24 antigen or confirmed HIV antibodies (Western blot or immunofluorescence)
- ✓Evidence of excess abdominal adipose deposition: Men waist >88.2 cm AND waist:hip ratio ≥0.95; Women waist >75.3 cm AND waist:hip ratio ≥0.9
- ✓Stable antiretroviral therapy (approved or under Treatment IND) for ≥30 days prior to entry
- ✓Age 18–60 years inclusive
- ✕Active AIDS-defining opportunistic infection or untreated/suspected serious systemic infection, or persistent fever ≥101°F in prior 30 days
- ✕Any active or prior malignancy except localized cutaneous Kaposi sarcoma (<10 lesions, none >2 cm, not on active therapy)
- ✕CNS mass or active CNS process with neurological findings
- ✕Unstable or untreated hypertension (≥140/90 mmHg at screening) or initiated/changed antihypertensive therapy within 30 days of entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 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 HARS
In Brief
A Phase 3 clinical trial evaluating Placebo, Serostim® 4 mg, and 1 other intervention for HIV Infections and Lipodystrophy. Completed, enrolled 326 participants across 31 sites in 2 countries.
Detailed Summary
The primary objective of the study is to determine if Serostim® 4 mg administered daily for 12 weeks as treatment for the abnormal fat accumulation and distribution associated with HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT, measured by CT scan) more effectively than placebo.
Study Details
Timeline
Interventions
Placebo matched to serostim® as subcutaneous injection.
Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight.
Serostim® 2 mg as subcutaneous injection on alternate days.