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TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

NCT00608023 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2022-09-30

Study results available
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Summary

Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation

Conditions

  • Lipodystrophy
  • HIV Infections

Interventions

DRUG

Tesamorelin

DRUG

Placebo for Tesamorelin

Sponsors & Collaborators

  • Theratechnologies

    lead INDUSTRY

Principal Investigators

  • Steven Grinspoon, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Spain
  • United Kingdom

Study Locations

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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 NCT00608023 on ClinicalTrials.gov