TH9507 in Patients With HIV-Associated Lipodystrophy

HIV Infections Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123253
• Other study ID #: TH9507/III/LIPO/010
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2005
• Last updated: November 26, 2013
• Start date: June 2005
• Est. completion date: April 2007

Study information

• Verified date: November 2013
• Source: Theratechnologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00435136

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: April 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• HIV-Associated Lipodystrophy Syndrome
• Lipodystrophy

Intervention

Drug:
• TH9507

Locations

Country	Name	City	State
Canada	Southern Alberta Clinic	Calgary	Alberta
Canada	Clinique Médicale du Quartier Latin	Montreal	Quebec
Canada	Clinique Médicale L'Actuel	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Sunnybrook and Women College Health Sciences Centre	Toronto	Ontario
Canada	St-Paul's Hospital	Vancouver	British Columbia
Canada	Windsor Regional Hospital	Windsor	Ontario
United States	Infectious Disease Physicians Inc.	Annandale	Virginia
United States	AIDS Research Consortium Atlanta (ARCA)	Atlanta	Georgia
United States	Central Texas Clinical Research	Austin	Texas
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	Bach & Godofsky	Bradenton	Florida
United States	Northern Healthcare	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Dallas VA Medical Centre	Dallas	Texas
United States	Office of Dr. Gary Richmond	Ft. Lauderdale	Florida
United States	The University of Texas Medical School	Houston	Texas
United States	Indiana University Department of Medicine	Indianapolis	Indiana
United States	UCLA School of Medicine	Los Angeles	California
United States	Care Resource Miami	Miami	Florida
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	St Luke's Roosevelt Hospital Centre	New York	New York
United States	St Vincent Catholic Medical Centre	New York	New York
United States	Orlando Immunology Center	Orlando	Florida
United States	Office of Dr. Michael Somero	Palm Springs	California
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Fanno Creek Clinic, LLC	Portland	Oregon
United States	UCSD Medical Center	San Diego	California
United States	Kaiser Permanente	San Francisco	California
United States	Infectious Disease Associates	Sarasota	Florida
United States	Swedish Medical Center	Seattle	Washington
United States	Community Research Initiative of New England (CRI West)	Springfield	Massachusetts
United States	Treasure Coast Infectious Disease Consultant (TDIDC)	Vero Beach	Florida
United States	Capital Medical Associates	Washington	District of Columbia
United States	AIDS Research Alliance	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
Theratechnologies

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visceral adipose tissue (VAT)