PACTR202311518894272Other2 期
Pharmacology of Tenofovir Disoproxil Fumarate-Emtricitabine (TDF-FTC) Pre-exposure Prophylaxis in Kenyan Cisgender Women
niversity of Washington0 个研究点目标入组 72 人开始时间: 2021年8月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- Female
入选标准
- •Inclusion criteria for the pregnant cohort
- •-Age =18 and =30 years
- •-HIV uninfected
- •-Has an active smart phone
- •-Normal renal function (GFR >60ml/min)
- •-Hepatitis B surface Ag negative
- •-High risk for HIV
- •-Pregnant at 13-26 weeks of gestation
- •-Willing to use DOT and come to clinic daily for DOT PrEP for 8 weeks
- •-Willing to have home visits/video streaming if clinic visit not feasible
- •Inclusion criteria for the non- pregnant cohort
- •-Age =18 and =30 years
- •-HIV uninfected
- •-Has an active smart phone
- •-Normal renal function (GFR >60ml/min)
- •-Hepatitis B surface Ag negative
- •-Low risk for HIV
- •-Not pregnant or breastfeeding
- •-Willing to be randomized to non-daily PrEP and come to clinic frequently for DOT PrEP
- •-Willing to have home visits/video streaming if clinic visit not feasible
排除标准
- •Exclusion criteria for pregnant women
- •-Inability to give informed consent
- •-HIV positive test at screening or suspected acute HIV infection in the opinion of the clinician
- •-Concomitant medications taken within 30 days of enrollment: aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or > 500mg valacyclovir for >7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.
- •-Current or past use of PrEP (pre-exposure prophylaxis)
- •-Not willing to have home visit
- •-Sickle cell anemia, chronic bleeding, blood transfusion within the past 120 days (excluding for chronic illness) or other blood dyscrasias
- •-Fetus has a known or suspected major congenital anomaly defined by fetal ultrasound.
- •Exclusion criteria for non-pregnant women
- •-Inability to give informed consent
- •-HIV positive test at screening or suspected acute HIV infection in the opinion of the clinician
- •-Concomitant medications taken within 30 days of enrollment: aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or > 500mg valacyclovir for >7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.
- •-Current or past use of PrEP (pre-exposure prophylaxis)
- •-pregnancy/plan to become pregnant in the next 6 months/unwillingness to use birth control
研究者
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