AIDS Wasting in Women: Anabolic Effects of Testosterone

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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