PAGE 19
HIV NUTRITION UPDATE
VOLUME 9, ISSUE 2
HIV Infection Clinical Trials

(Continued from page 18)

 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women (continued)
 

* Protocol Outline: 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 two 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. 

* Eligibility Criteria- HIV-positive female (age 18-50)

* Inclusion Criteria-

  • Disease Characteristics: Histologically confirmed premenopausal HIV-positive women who have experienced 5-15% weight loss 
  • Prior/Concurrent Therapy: 
    • Endocrine therapy: At least three months since megestrol, anabolic or androgenic steroids, oral contraceptives, Depo-Provera; no concurrent hormone replacement therapy
    • Other: Concurrent retroviral or protease inhibitors allowed, dosage must be stable. At least three months since ketoconazole; At least six weeks since the initiation of protease inhibitors 
  • Patient Characteristics
    • Hepatic: No significant liver disease SGOT/SGPT, no greater than three times upper limit of normal (ULN); Alkaline phosphatase no greater than three times ULN, Bilirubin no greater than 2 mg/dL
    • No medical complications due to alcohol abuse
    • No significant cardiovascular disease or 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; malignant disease; history of breast cancer, endometrial cancer, or history of hyperandrogenic disorders such as: Hirsutism Polycystic ovary disease; fever; significant respiratory disease; or diabetes
    • No illicit drugs within the past 6 months
    • Not pregnant or lactating 


Location and Contact Information: 

* Charles R. Drew University of Medicine and Science, LA, CA, U.S. Recruiting- Shalender Bhasin, Study Chair, 213/563-9353 

*LA County Harbor-UCLA Medical Center, Torrance, CA, U.S. Recruiting- G. Beall, 310/222-2444 

* Washington University School of Medicine, Saint Louis, MO, U.S. Recruiting- K. Yarashaski, 314/362-9700 

Record first received: October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004400
 
 
 
 

   

 

 

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11/23/2004