Conditions: HIV Infections Lipodystrophy
Keywords: Growth hormone Serostim® Human Adipose Redistribution Syndrome Human Immunodeficiency Virus lipodystrophy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 326
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Subjects will receive placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks. arm 2: Subjects will receive Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks. arm 3: All subjects who will be initially randomized to Serostim® 4 mg arm in Period I and will receive placebo matched to Serostim® on alternate days for 24 weeks in Period II. arm 4: All subjects who will be initially randomized to Serostim® 4 mg arm in Period I and will receive Serostim® 2 mg on alternate days for 24 weeks in Period II. arm 5: All subjects who will be initially randomized to Placebo arm in Period I continue receiving placebo matched to Serostim® on alternate days for 12 weeks followed by Serostim® 4 mg daily 12 weeks.

Interventions: intervention 1: Placebo intervention 2: Serostim® 4 mg intervention 3: Serostim® 2 mg
Intervention descriptions: intervention 1: Placebo matched to serostim® as subcutaneous injection. intervention 2: Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight. intervention 3: Serostim® 2 mg as subcutaneous injection on alternate days.

Protocol document: