AIDS Wasting Syndrome
Conditions
Keywords
AIDS, HIV, weight loss, Wasting Syndrome, testosterone, androgen levels, hormones
Brief 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.
Interventions
DRUGTestosterone
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed