PACTR202209528604242尚未招募2 期
Safety and Pharmacokinetics of TAF-FTC Pre-Exposure Prophylaxis in Kenyan Cisgender women- of TDF-FTC Pre-exposure Prophylaxis in Kenyan Cisgender women.
niversity of Washington0 个研究点目标入组 54 人开始时间: 2022年2月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
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
- •For all cisgender women
- •- Age =18 and =30 years old.
- •- Willing to undergo urine pregnancy tests.
- •- Has understood the information provided and has provided written informed consent before
- •any study-related procedures are performed..
- •- HIV uninfected based on negative HIV rapid tests, according to Kenyan national algorithm.
- •- Normal renal function (estimated glomerular filtration rate >60 mL/min).
- •- Hepatitis B surface antigen Ag negative..
- •- No active, clinically significant medical or psychiatric conditions that, in the opinion of the
- •investigators, would interfere with study participation .
- •- Lack of severe anemia (Hemoglobin >10 g/dL).
- •- Willing to use DOT and come to clinic frequently for DOT PrEP for at least 10 weeks.
- •- Willing to have home visits for follow up.
- •- Has access to an active smartphone to allow off-site observation of dosing if unable to come
- •to the clinic, or, as determined by the study staff, the participant resides in a close enough
- •location to the clinic to permit a home visit if unable to come to the clinic. That isi.e., potential
- •participants without a smartphone may be enrolled in the study if investigator determines that
- •the participant resides within reasonable distance from the clinic that would permit home visit
- •ID the participant misses their visit for a home visit in the case of a missed clinic visit.
- •- Intention to stay within the study site’s catchment area for at least 10 weeks.
- •Women TAF-FTC Benchmark Study.
- •- Resides or works in catchment area with high speed internet coverage to permit video
- •- Not pregnant or breast feeding.
- •- Willing to use effective contraception during the study period.
- •- At low risk for HIV. In Kenya, national guidelines define substantial risk for HIV and
- •recommend PrEP be an option for individuals reporting: partner of HIV-infected person not on
- •ART or on ART for <6 months, >1 partner of unknown status, transactional sex, recent STI,
- •recurrent PEP use,
排除标准
- •For all cisgender women
- •– Inability to give informed consent
- •– Positive screening HIV+ as determined by standard rapid serologic assays or suspected acute
- •HIV infection in the opinion of the clinician. (Eexample signs and symptoms of acute HIV
- •infection include combinations of fever, headache, fatigue, arthralgia, vomiting, myalgia,
- •diarrhea, pharyngitis, rash, night sweats, and cervical or inguinal adenopathy cervical or
- •– Positive HBV surface antigen test at screening.
- •– Calculated creatinine clearance <60 ml/min.
- •– Any laboratory value or uncontrolled medical conditions that, in the opinion of the
- •investigators, would interfere with the study conditions such as, heart disease and/or cancer.
- •– Prohibited concomitant medications are: investigational agents (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®, TRUVADA®, 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 visits.
- •– Pregnantcy or plan to become pregnant in the next 6 months or unwillingness to use birth
- •– Currently breastfeeding.
- •– High risk of HIV infection (for example: sexually active with an HIV infected partner; engages
- •in condomless intercourse with HIV-infected partners or partner of unknown status during the
- •study; females who exchanges sex for money, shelter, or gifts; active injection drug use or
- •during the last 12 months; newly diagnosed sexually transmitted infections in last 6 months.
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