Brief Title
TH9507 in Patients With HIV-Associated Lipodystrophy
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Visceral adipose tissue (VAT)
Condition
HIV Infections
Intervention
TH9507
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
412
Start Date
June 2005
Completion Date
April 2007
Primary Completion Date
November 2006
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Steven Grinspoon, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00123253
Organization ID
TH9507/III/LIPO/010
Study Sponsor
Theratechnologies
Study Sponsor
Steven Grinspoon, MD, Principal Investigator, Massachusetts General Hospital
Verification Date
November 2013