NCT00006158已完成2 期
AIDS Wasting in Women: Anabolic Effects of Testosterone
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)2 个研究点 分布在 1 个国家开始时间: 1998年9月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
研究点 (2)
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