TH9507 in Patients With HIV-Associated Lipodystrophy

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Southern Alberta Clinic, Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TH9507

Drug

Primary outcomes

Visceral adipose tissue (VAT)

Sponsors and collaborators

Lead sponsor

Theratechnologies

Industry

Registry information

Official study title

A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Patients With Excess of Abdominal Fat Accumulation

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2007
First posted: Jul 22, 2005
Registry last updated: Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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