This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.
| Registry number | NCT00123253 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Sponsor | Theratechnologies |
| Enrollment | 412 participants |
| Design | Interventional, Randomized, Parallel, Masking: Double |
| Conditions | HIV Infections; Lipodystrophy |
| Interventions | TH9507 |
| Start | Jun 2005 |
| Primary completion | Nov 2006 |
| Study completion | Apr 2007 |
| Results posted | Not yet |
| Registry last updated | Nov 27, 2013 |
Compounds on this site that cite this trial
What the registry says the trial is about
HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from a previous randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV patients with an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with no significant changes in limb fat and subcutaneous adipose tissue (SAT). This study is aimed at further assessing the efficacy and safety of 2 mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess of abdominal fat accumulation.
Primary outcomes
These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.
| Outcome measure | Time frame |
|---|---|
| Visceral adipose tissue (VAT) |
Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 3, 2026. See the trial changes feed for what has changed recently.
