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.

INTERVENTION: Product Name: Tesamorelin Product Code: TH9507 Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: Tesamorelin CAS Number: 218949‐48‐5 Current Sponsor code: TH9507 Other descriptive name: [N‐trans‐3‐Hexenoyl] Human Growth Hormone Releasing Factor (1‐44) Acetate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.1‐ Pharmaceutical form of the placebo: Powder and solvent for suspension for injection Route of administration of the placebo: Subcutaneous use CONDITION: HIV‐associated lipodystrophy ; MedDRA version: 9.1 Level: LLT Classification code 10024608 Term: Lipodystrophy PRIMARY OUTCOME: Main Objective: This study is an extension to study TH9507‐CTR‐1011 (EudraCT number 2006‐005444‐88) to assess long‐term safety of 2 mg/day TH9507 (26 weeks in a population previously receiving placebo in the TH9507‐CTR‐1011 study; 52 weeks for a subgroup of subjects previously receiving TH9507 in the TH9507‐CTR‐1011 study) Primary end point(s): 1. Safety parameters as outlined in section 3.2.1 of the Protocol.; 2. Efficacy endpoints:; (a) VAT, trunk fat and lipid profile measured through time;; (b) The percentage of subjects who gained back some or all VAT lost during the first 26 weeks, at Week 39 and Week 52.; Secondary Objective: 1. To assess over a 26‐week placebo treatment period, the duration of effect on VAT, trunk fat and lipid profile following a 26‐week treatment with 2 mg/day TH9507 as compared to baseline and Week 26;; 2. To collect data on efficacy after a 52‐week treatment with 2 mg/day TH9507; 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