TH9507 in Patients With HIV-Associated Lipodystrophy

Completed · Phase 3

Conditions studied: HIV Infections, Lipodystrophy

In brief

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.

Key facts

Study ID

NCT00123253

Run by

Theratechnologies

People needed

412

Starts

2005-06-01

Expected to finish

2007-04-01

Last updated by the study team

2013-11-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UCLA School of Medicine — Los Angeles, California, United States
• Office of Dr. Michael Somero — Palm Springs, California, United States
• UCSD Medical Center — San Diego, California, United States
• Kaiser Permanente — San Francisco, California, United States
• AIDS Research Alliance — West Hollywood, California, United States
• Capital Medical Associates — Washington D.C., District of Columbia, United States
• Bach & Godofsky — Bradenton, Florida, United States
• Office of Dr. Gary Richmond — Fort Lauderdale, Florida, United States
• Care Resource Miami — Miami, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Infectious Disease Associates — Sarasota, Florida, United States
• Treasure Coast Infectious Disease Consultant (TDIDC) — Vero Beach, Florida, United States
• AIDS Research Consortium Atlanta (ARCA) — Atlanta, Georgia, United States
• Northern Healthcare — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Indiana University Department of Medicine — Indianapolis, Indiana, United States
• Institute of Human Virology — Baltimore, Maryland, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Community Research Initiative of New England — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Tufts University School of Medicine — Boston, Massachusetts, United States
• Community Research Initiative of New England (CRI West) — Springfield, Massachusetts, United States
• Hennepin County Medical Centre — Minneapolis, Minnesota, United States
• AIDS Community Research Initiative of America — New York, New York, United States
• Bellevue Hospital Center New York University — New York, New York, United States

Full record on ClinicalTrials.gov

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