NCT00294164

Safety and Efficacy Trial of Serostim® in the Treatment of Subjects With Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)

Phase 2/3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Safety and Efficacy Trial of Subcutaneously Administered Serostim® (Mammalian Cell-derived Recombinant Human Growth Hormone, r-hGH) in the Treatment of Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 2/3, multicenter, double-blind, randomized, parallel-group, placebo-controlled, dose-finding trial of Serostim® (mammalian cell-derived recombinant human growth hormone, r-hGH) versus placebo in subjects 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; and 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 subject assessments of change in body shape, health-related quality of life, attitude towards medication compliance, metabolic markers, fat redistribution, and safety. On Day 1, eligible subjects 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 milligram (mg). Therapy will continue for 12 weeks. Treatment will then be altered and the new treatment will be continued through Week 24. Interim Study Visits will be required at Weeks 2 and 4 (Treatment Period 1) and at Weeks 14 and 16 (Treatment Period 2). Subjects will be offered to be enrolled into a maintenance Protocol (Study 23056) at Week 24.

Conditions

• Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)
• Human Immunodeficiency Virus Infections

Interventions

Type	Name	Description
DRUG	Serostim®	Serostim® will be administered subcutaneously (daily or given on alternate days with matched placebo), at a dose based on body weight measured at Baseline, with a maximum daily dose of 4 mg up to Week 24.
DRUG	Placebo	Matching placebo will be administered subcutaneously (daily or given on alternate days with Serostim®), up to Week 24.

Timeline

• Start date: 2001-03-01
• Primary completion: 2002-05-01
• Completion: 2002-05-01
• First posted: 2006-02-20
• Last updated: 2014-03-26