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.

Condition	Treatment or Intervention	Phase
HIV Infections Cachexia	Drug: testosterone	Phase II

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of three arms. Arm I: Patients receive two placebo transdermal patches applied twice a week (every 3-4 days). Arm II: Patients receive one testosterone transdermal patch and one placebo transdermal patch applied twice a week (every 3-4 days). Arm III: Patients receive two testosterone transdermal patches applied twice a week (every 3-4 days). Patients receive 12 weeks of treatment in the absence of adverse reaction or health deterioration. Patients are followed on day 1, every 2 weeks during treatment, and at the end of the recovery period. Quality of life is assessed before treatment begins and at weeks 6 and 12.

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Female

Criteria

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

California
      Charles R. Drew University of Medicine and Science, Los Angeles,  California,  90059,  United States; Recruiting
      Los Angeles County Harbor-UCLA Medical Center, Torrance,  California,  90509,  United States; Recruiting
Missouri
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States; Recruiting

Study chairs or principal investigators

Shalender Bhasin,  Study Chair,  Charles R. Drew University of Medicine and Science   

Study ID Numbers:  199/13251; CDUMS-FDR001397
Record last reviewed:  May 1998
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004400
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09