TH9507 in Patients With HIV-Associated Lipodystrophy

Theratechnologies

Status and phase

Completed

Phase 3

Conditions

Lipodystrophy

HIV Infections

Treatments

Drug: TH9507

Study type

Interventional

Funder types

Industry

Identifiers

NCT00123253

TH9507/III/LIPO/010

Details and patient eligibility

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.

Enrollment

412 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ages 18 to 65 years inclusive
HIV positive; CD4 cell counts >100 cells/mm3; viral load <10,000 copies/mL (stable for 8 weeks)
On stable ART regimen for at least 8 weeks prior to randomization
Have evidence of abdominal fat accumulation defined by the following anthropometric cut off values:
- For males: waist circumference > 95 cm and waist to hip ratio > 0.94;
- For females: waist circumference > 94 cm and waist to hip ratio > 0.88.
Females of childbearing potential not pregnant or lactating; normal mammography within 6 months of study.
Signed informed consent

Exclusion criteria

Body mass index < 20 kg/m2
Opportunistic infection; HIV-related disease within 3 months of study.
History of malignancy; active neoplasm.
Prostate-specific antigen (PSA) >5 ng/mL at screening
Hypopituitarism; history of pituitary tumor/surgery; head irradiation; head trauma that has affected the somatotropic axis.
Untreated hypothyroidism
Type 1 diabetics and type 2 diabetics on oral hypoglycemic or insulin sensitizing agent within 6 months of study
ALT or AST > 3 x ULN; serum creatinine > 133 mmol/L (1.5 mg/dL); hemoglobin more than 20 g/L below LLN; fasting blood glucose > 8.33 mmol/L (150 mg/dL); fasting triglycerides > 11.3 mmol/L (0.99 g/dL).
Untreated hypertension
Change in anti-hyperlipemic regimen within 3 months prior to study
Change in testosterone regimen and/or supraphysiological dose of testosterone
Estrogen therapy
Anoretics/anorexigenics or anti-obesity agents within 3 months of study
Growth hormone (GH); GH secretagogues; growth hormone releasing factor (GRF) products; IGF-1; or IGFBP-3 within 6 months of study.
Drug or alcohol dependence or use of methadone within 6 months of study entry
Participation in a clinical trial with any investigational drug/device within 30 days of screening.