TH9507 in Patients With HIV-Associated Lipodystrophy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00123253
• Date of registration: 20/07/2005
• Prospective Registration: No
• Primary sponsor: Theratechnologies
• Public title: TH9507 in Patients With HIV-Associated Lipodystrophy
• Scientific 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
• Date of first enrolment: June 2005
• Target sample size: 412
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00123253
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Steven Grinspoon, MD
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Lipodystrophy

Intervention(s)

Drug: TH9507

Primary Outcome(s)

Visceral adipose tissue (VAT)

Secondary ID(s)

TH9507/III/LIPO/010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors