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Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients

NCT00082628 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2018-07-20

Study results available
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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.

Conditions

  • HIV Infections
  • Lipodystrophy

Interventions

DRUG

Placebo

Placebo matched to serostim® as subcutaneous injection.

DRUG

Serostim® 4 mg

Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight.

DRUG

Serostim® 2 mg

Serostim® 2 mg as subcutaneous injection on alternate days.

Sponsors & Collaborators

Principal Investigators

  • Medical Responsible · EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-28
Primary Completion
2005-09-28
Completion
2005-09-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00082628 on ClinicalTrials.gov