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An Efficacy and Safety Trial of Serostim® in the Maintenance of the Treatment Effect Obtained During the Study of Serostim® in Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome

NCT00294918 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2014-03-26

No results posted yet for this study

Summary

This is an open-label, multi-center, randomized, parallel-group, maintenance trial of Serostim® in subjects who have completed a prior Serostim® Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) trial (Study 22388). The subjects, who encountered toxicity during the antecedent protocol, will be assigned to a 1 milligram (mg) dose. All other subjects will be randomized in 1:1 ratio, to receive up to 2 mg or 4 mg of Serostim®, beginning from Day 1 of Week 1. Doses will be adjusted downward in subjects weighing less than 55 kilogram (kg). Serostim® therapy will be continued at the assigned doses through Week 12 (Period 1). Subjects, who will encounter toxicity during Period 1, will be assigned to the 1 mg group for Period 2. All other subjects will be randomized in a 1:1 ratio to receive up to 2 mg or 1 mg of Serostim® on a weight adjusted basis. Period 2 therapy will begin on Day 1 of Week 13, continuing through Week 36. Study visits are required at Screening (that is, Final Visit of the antecedent trial), Day 1 of Week 1 (Baseline), and at Weeks 2, 6, 12, 14, 24, 30 and 36.

Conditions

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

Interventions

DRUG

Serostim®

Serostim® will be administered subcutaneously at a dose of 1 mg to subjects who had encountered toxicity during the antecedent protocol (Study 22388) whereas, other subjects will be randomized in 1:1 ratio, to receive either 2 milligram (mg) or 4 mg (on a weight adjusted basis) daily, starting from Day 1 of Week 1 up to Week 12 (Period 1). During Period 1, subjects who encounter toxicity will receive 1 mg Serostim® subcutaneously, daily for Period 2, starting from Day 1 of Week 13, whereas other subjects will be randomized in a 1:1 ratio to receive either 2 mg or 1 mg (on a weight adjusted basis) up to Week 36.

Sponsors & Collaborators

Principal Investigators

  • Norma Muurahainen, M.D. PhD · EMD Serono

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2003-02-28
Completion
2003-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00294918 on ClinicalTrials.gov