Androgen Effects in HIV-infected Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Lean Body Mass
研究概览
简要总结
Androgen deficiency in HIV-infected women is associated with sarcopenia and may cause critical reductions in physical functioning and reduced bone density. The effects of long-term androgen therapy on lean body mass, bone density and other clinical endpoints including quality of life, functional status and neurocognitive function in HIV-infected women are not known.
详细描述
We will perform an 18-month randomized, double-blinded, placebo-controlled study among relatively androgen deficient women with HIV, to determine the effects of testosterone administration on lean body mass. The administered dose will be 300 micrograms twice a week vs. identical placebo in the form of a transdermal preparation. Secondary endpoints include effects on bone density, quality of life, neurocognitive function and menstrual function. Open label administration at 300 micrograms twice a week will be initiated for 12 months in all subjects following the randomized portion of the study. Assuming a 15% dropout rate and 25 randomized patients, the probability is 80 percent that the study will detect a treatment difference at a two sided 5.000 percent significance level, if the true difference between the treatments is 2.7 kg. This is based on the assumption that the standard deviation of the response variable, lean body mass by DEXA, is 2.3 kg, as was shown by Choi et al1 over 12 weeks in HIV-infected women at the same dose of 300 ug 2x/week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female 18 - 55
- •BMI less than or equal to 26
- •HIV-infected
- •Androgen deficient, with free testosterone < 3 pg/mL
- •Stable antiretroviral regimen for 3 months prior to study
- •Tubal ligation, hysterectomy, or verbalized understanding of appropriate barrier contraception methods. Subjects will be counseled in appropriate barrier contraception methods and the counseling will be documented.
排除标准
- •Use of anabolic agent, including testosterone, GH or other preparations within 3 months of the study.
- •Use of megestrol acetate within 3 months of the study
- •Use of estrogen or any preparation known to affect bone density or bone turnover.This includes oral contraceptives, depo provera or combined progesterone-estrogen injections, and transdermal contraceptive patches.
- •Pregnant or breast-feeding
- •Hgb < 9.0 mg/dL
- •Current participation in another research study conducted by this investigator or past participation in the DHEA study funded by the same grant as this protocol.
- •Creatinine > 1.5 mg/dL
研究组 & 干预措施
1 Transdermal Testosterone (Patch)
300 micrograms applied twice a week
干预措施: 1 Transdermal Testosterone (Patch) (Drug)
2 Placebo Patch (identical in appearance)
placebo patch (0 micrograms of testosterone)applied twice a week
干预措施: 2 Placebo Patch (Drug)
结局指标
主要结局
Lean Body Mass
时间窗: Baseline (time 0) to 18 months
Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for lean body mass measured by dual energy absorptiometry (DEXA)scan.
次要结局
- Bone Mineral Density of the Hip(Baseline (time 0) to 18 months)
- Quality of Life/Depression: Becks Depression Inventory(Baseline (time 0) to 18 months)
- Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function(Baseline (time 0) to 18 months)
- Safety: Number of Subjects Reporting a Skin Reaction to the Patch(Baseline (time 0) to 18 months)
- Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs)(Baseline (time 0) to 18 months)
- Safety: Number of Subjects Reporting Acne(Baseline (time 0) to 18 months)
- Safety: Number of Subjects Reporting a Change in Menstrual Status (Reported More Than One Period in 1 Month or Missed a Period During a Monthly Cycle)(Baseline (time 0) to 18 months)
- Neurocognitive Function: Hopkins Verbal Learning Test-revised,"Total Recall" Z Score Represents Change in Z Score From Baseline to 18 Months.(Baseline (time 0) to 18 months)
- Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing.(Baseline (time 0) to 18 months)
- Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing.(Baseline (time 0) to 18 months)