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Home > "A" Clinical Trials Conditions > AIDS Wasting in Women: Anabolic Effects of Testosterone  AIDS Wasting in Women: Anabolic Effects of Testosterone
AIDS Wasting in Women: Anabolic Effects of Testosterone
For Condition: AIDS Wasting Syndrome
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: The study is a 6 month, placebo-controlled study of transdermal testosterone for women with HIV-associated weight loss. Women with AIDS wasting have been found to have low testosterone levels. This study is designed to test the efficacy of physiologic testosterone dosing to improve weight, muscle mass and quality of life indices, including energy level, appetite and libido, in androgen deficient women with AIDS wasting. After 6 months, all women receive open label transdermal testosterone for an additional 6 months.
Details:
Eligibility:
Study Type: Interventional, Treatment, Open Label, Placebo Control
Minimum Age/Maximum Age: 18 Years/45 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Females using acceptable form of birth control during study, including barrier contraception or IUD but excluding oral contraceptives or Depo-Provera - Documented HIV infection - Free testosterone level 3.0 pg/mL - Weight < 90% or weight loss > 10% of pre-illness weight Exclusion Criteria: - Pregnant or actively seeking pregnancy - Breast feeding - New opportunistic infection diagnosed within 4 weeks of the study - Requiring parenteral nutrition or pharmacologic glucocorticoid therapy - Intractable diarrhea (6 stools/day) - Androgen, estrogen, progestational derivative, or glucocorticoid administration within 3 months of the study, including Megace - New retroviral therapy within 6 weeks of study - SGOT > 5 X normal and/or clinically significant liver disease - Creatinine > 2.0 mg/dL and/or clinically significant renal disease - Hgb < 8.0 g/dL - Active substance abuse or alcoholism
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenGrinspoon, Principal Investigator, Massachusetts General Hospital
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Additional Information:
Study ID Numbers: anabole; DK54167
Study Start Date: September 1998
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006158
Other Aids Wasting Syndrome Studies:
1. AIDS Wasting in Women: Anabolic Effects of Testosterone
Related Studies:
Other AIDS Wasting Syndrome Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
AIDS Wasting in Women: Anabolic Effects of Testosterone
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