HIV Infections Clinical Trial
Verified date | May 1998 |
Source | FDA Office of Orphan Products Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
OBJECTIVES: I. Determine whether physiologic testosterone replacement can increase fat-free
mass, therefore contributing to weight maintenance, improved muscle function, and quality of
life in HIV-infected women.
II. Examine the mechanism of testosterone-induced increase in fat-free mass.
Status | Completed |
Enrollment | 56 |
Est. completion date | September 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed premenopausal HIV-positive women who have experienced 5-15% weight loss --Prior/Concurrent Therapy-- - Endocrine therapy: At least 3 months since megestrol At least 3 months since anabolic or androgenic steroids At least 3 months since oral contraceptives At least 3 months since Depo-Provera No concurrent hormone replacement therapy - Other: Concurrent retroviral or protease inhibitors allowed, dosage must be stable At least 3 months since ketoconazole At least 6 weeks since the initiation of protease inhibitors --Patient Characteristics-- - Hepatic: No significant liver disease SGOT/SGPT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Bilirubin no greater than 2 mg/dL No medical complications due to alcohol abuse - Renal: Not specified - Cardiovascular: No significant cardiovascular disease No uncontrolled hypertension - Other: Testosterone level (early morning) less than 30 ng/dL Normal gastrointestinal function as indicated by: Absence of diarrhea Normal D-xylose absorption test No acute opportunistic infections or infectious illness No malignant disease No history of breast cancer No history of endometrial cancer No fever of known or unknown origin No unremitting diarrhea defined as: At least 4 watery stools per day OR More than 4 watery stools recently OR Acute change in stool habit with fever No significant respiratory disease No diabetes No illicit drugs within the past 6 months No history of hyperandrogenic disorders such as: Hirsutism Polycystic ovary disease Not pregnant or lactating |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Charles R. Drew University of Medicine and Science | Los Angeles | California |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Los Angeles County Harbor-UCLA Medical Center | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Charles Drew University of Medicine and Science |
United States,
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