TH9507 in Patients With HIV-Associated Lipodystrophy
- Conditions
- LipodystrophyHIV Infections
- Registration Number
- NCT00123253
- Lead Sponsor
- Theratechnologies
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 412
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Visceral adipose tissue (VAT)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (42)
Community Research Initiative of New England (CRI West)
🇺🇸Springfield, Massachusetts, United States
Bellevue Hospital Center New York University
🇺🇸New York, New York, United States
Infectious Disease Physicians Inc.
🇺🇸Annandale, Virginia, United States
AIDS Research Alliance
🇺🇸West Hollywood, California, United States
St Luke's Roosevelt Hospital Centre
🇺🇸New York, New York, United States
AIDS Community Research Initiative of America
🇺🇸New York, New York, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Windsor Regional Hospital
🇨🇦Windsor, Ontario, Canada
St-Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
AIDS Research Consortium Atlanta (ARCA)
🇺🇸Atlanta, Georgia, United States
UCSD Medical Center
🇺🇸San Diego, California, United States
Infectious Disease Associates
🇺🇸Sarasota, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Kaiser Permanente
🇺🇸San Francisco, California, United States
Bach & Godofsky
🇺🇸Bradenton, Florida, United States
Care Resource Miami
🇺🇸Miami, Florida, United States
Northern Healthcare
🇺🇸Chicago, Illinois, United States
Community Research Initiative of New England
🇺🇸Boston, Massachusetts, United States
Indiana University Department of Medicine
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Institute of Human Virology
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Tufts University School of Medicine
🇺🇸Boston, Massachusetts, United States
Hennepin County Medical Centre
🇺🇸Minneapolis, Minnesota, United States
Fanno Creek Clinic, LLC
🇺🇸Portland, Oregon, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Dallas VA Medical Centre
🇺🇸Dallas, Texas, United States
The University of Texas Medical School
🇺🇸Houston, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Sunnybrook and Women College Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
St Vincent Catholic Medical Centre
🇺🇸New York, New York, United States
Capital Medical Associates
🇺🇸Washington, District of Columbia, United States
Office of Dr. Gary Richmond
🇺🇸Ft. Lauderdale, Florida, United States
Treasure Coast Infectious Disease Consultant (TDIDC)
🇺🇸Vero Beach, Florida, United States
Clinique Médicale L'Actuel
🇨🇦Montreal, Quebec, Canada
Office of Dr. Michael Somero
🇺🇸Palm Springs, California, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Clinique Médicale du Quartier Latin
🇨🇦Montreal, Quebec, Canada
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
Southern Alberta Clinic
🇨🇦Calgary, Alberta, Canada