TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

Theratechnologies

Status and phase: Completed; Phase 3

Conditions: Lipodystrophy; HIV Infections

Treatments: Drug: Tesamorelin; Drug: Placebo for Tesamorelin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00608023

TH9507-CTR-1012

Details and patient eligibility

About

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

Full description

HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.

Enrollment: 263 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study.
• Signed informed consent before any trial-related activities.

Exclusion criteria

• Fasting blood glucose >8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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263 participants in 3 patient groups

Tesamorelin 12 months (T-T)

Experimental group

Description:

Tesamorelin 2 mg/day for 12 months

Treatment:

Drug: Tesamorelin

Tesamorelin-Placebo (T-P)

Experimental group

Description:

Tesamorelin 2 mg/day for 6 months - Placebo for 6 months

Treatment:

Drug: Placebo for Tesamorelin

Drug: Tesamorelin

Placebo-Tesamorelin (P-T)

Experimental group

Description:

Placebo 6 months - Tesamorelin 2 mg/day for 6 months

Treatment:

Drug: Placebo for Tesamorelin

Drug: Tesamorelin