Status:
COMPLETED
TH9507 in Patients With HIV-Associated Lipodystrophy
Lead Sponsor:
Theratechnologies
Conditions:
HIV Infections
Lipodystrophy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT00123253
Start Date
June 1 2005
End Date
April 1 2007
Last Update
November 27 2013
Active Locations (42)
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1
UCLA School of Medicine
Los Angeles, California, United States
2
Office of Dr. Michael Somero
Palm Springs, California, United States
3
UCSD Medical Center
San Diego, California, United States
4
Kaiser Permanente
San Francisco, California, United States