A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study 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
- HIV-associated lipodystrophyMedDRA version: 9.1Level: LLTClassification code 10024608Term: Lipodystrophy
- Registration Number
- EUCTR2007-003233-16-FR
- Lead Sponsor
- Theratechnologies Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
1. Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study.
2. Signed informed consent before any trial-related activities.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Fasting blood glucose >8.33 mmol/L (150 mg/dL) at the end of the TH9507-CTR-1011 study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method