AIDS Wasting in Women: Anabolic Effects of Testosterone

Completed · Phase 2

Conditions studied: AIDS Wasting Syndrome

In brief

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.

Key facts

Study ID

NCT00006158

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Starts

1998-09-01

Expected to finish

2004-12-01

Last updated by the study team

2010-02-15

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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