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

Conditions:Other Indications, Infectious Disease, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Other
Age Range:18 - 50
Start Date:April 1997

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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.

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

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.


--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

--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
We found this trial at
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
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1731 E 120th Street
Los Angeles, California 90059
Los Angeles, CA
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1000 W Carson St
Torrance, California 90509
Torrance, CA
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