Safety and Efficacy Trial of Subcutaneously Administered Serostim® in the Treatment of Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (HARS)
This study is a Phase 2/3 multicenter, double-blind, randomized, parallel-group, placebo-controlled, dose-finding trial of Serostim® vs. placebo in 228 patients with Human Immunodeficiency Virus-Associated Adipose Tissue Redistribution Syndrome (HARS).
The primary study objective is to determine whether Serostim® treatment reduces adipose tissue maldistribution more effectively than placebo. The primary co-endpoints are derived from measures of visceral adipose tissue assessed by Computerized Tomography (CT) and the ratio of trunk:limb fat assessed by Dual-Energy X-Ray Absorptiometry (DXA) scans. Anthropometric Measures, Physical Exams, Quality of Life assessments, Serial Photographs, and various laboratory measures will be used to address secondary objectives. These secondary objectives relate to the impact of Serostim® on physician and patient assessments of change in body shape, health-related quality of life, attitudes toward medication compliance, metabolic markers, fat redistribution, and safety.
On Day 1, eligible patients will be randomized in a 1:1:1 ratio to receive daily Serostim®, Serostim® and placebo given on alternate days, or daily placebo. Serostim® doses will be based on body weight, with a maximum dose of 4 mg.
Therapy will continue for 12 weeks. Treatment will then be altered (Figure1) and the new treatment continued through Week 24. Interim Study Visits are required at Weeks 2 and 4 (Treatment Period I) and at Weeks 14 and 16 (Treatment Period II). Patients will be offered a maintenance protocol at Week 24.
Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (HARS)
Drug: recombinant human growth hormone (r-hGH)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment