Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 518
- 试验地点
- 4
- 主要终点
- Changes in bone mineral density
研究概览
简要总结
The MTN-003 HIV prevention study include the use of microbicides, substances that kill microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on bone mineral density (BMD).
详细描述
The effect of tenofovir on bone mineral density (BMD) has not yet been studied and is of potential concern. The purpose of this study is to determine the changes in BMD among individuals receiving TDF and FTC/TDF compared with a placebo.
This substudy will enroll individuals currently participating in MTN-003. The expected duration of participation for each participant is approximately 48 months. Study treatment will be provided by MTN-003. Study treatment will not be provided by this substudy.
Study visits will occur every 6 months after enrollment. A nutrition assessment, physical activity history, and urine and blood collection will occur at all visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Enrolled in MTN-003
- •Randomized to oral study product in MTN-003 within 14 days prior to study entry
排除标准
- •Medical condition known to affect bone or taking any medication known to affect bone. More information on this criterion can be found in the protocol.
- •Permanently discontinued from oral study product in MTN-003 prior to study entry
- •Any condition that, in the opinion of the investigator, would interfere with the study
研究组 & 干预措施
1
Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.
干预措施: Emtricitabine/tenofovir disoproxil fumarate (Drug)
1
Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.
干预措施: Emtricitabine/tenofovir disoproxil fumarate placebo (Drug)
1
Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.
干预措施: Tenofovir disoproxil fumarate (Drug)
1
Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.
干预措施: Tenofovir disoproxil fumarate placebo (Drug)
结局指标
主要结局
Changes in bone mineral density
时间窗: Throughout study
次要结局
- Changes in nutrition(Throughout study)