PACTR202003492130332尚未招募3 期
A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
Division of HIV and AIDS0 个研究点目标入组 200 人开始时间: 2020年2月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
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
- •Born female
- •18-45 years at the time of screening
- •Willing and able to provide informed consent
- •Willing and able to undergo all required study procedures
- •Non-reactive HIV test results at Screening and Enrollment*
- •Sexually active (i.e., vaginal intercourse on a minimum of two separate days in the 30 days prior to Screening)
- •Score of >5 using a modified VOICE risk score51
- •No plans to re-locate or travel away from the site for >8 consecutive weeks during study participation
- •Creatinine clearance =60 mL/min (using Cockcroft-Gault equation) (use sex at birth for calculation)
- •Although not protocol exclusionary, sites should carefully consider the advisability of enrolling participants with calculated creatinine clearance between 60-70 mL/min, as limited changes in creatinine clearance during study conduct will lead to protocol-mandated product holds and may alter the risk-benefit considerations of study participation
- •Hepatitis B virus (HBV) surface antigen (HBsAg) negative and accepts vaccination
- •Alanine aminotransferase (ALT) < 2x upper limit of normal (ULN) and total bilirubin (Tbili) = 2.5 x ULN
- •HCV antibody negative
- •If of reproductive potential (defined as pre-menopausal women who have not had a sterilization procedure per self-report, such as hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy), must have a negative beta human chorionic gonadotropin (ßHCG) pregnancy test (sensitivity of = 25 mIU/mL) performed (and results known) on the same day as and before initiating the protocol-specified study product(s) at Enrollment.
排除标准
- •One or more reactive HIV test results at Screening or Enrollment, even if HIV infection is not confirmed
- •Pregnant or currently breastfeeding, or intends to become pregnant and/or breastfeed during the study • Co-enrollment in any other HIV interventional research study (provided by self-report or other available documentation), with one exception: IMPAACT 2026 (co-enrollment in IMPAACT 2026 is permitted for participants who become pregnant) • Current or past enrollment in an HIV vaccine or broadly neutralizing antibody trial • Current or chronic history of liver disease (e.g., non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy)
- •HPTN 084, FINAL, Version 2.0 46 of 150
- •6 November 2019
- •History of seizure disorder, per self-report
- •Clinically significant cardiovascular disease, as defined by history/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease
- •Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the Investigator of Record (IoR). Mild skin conditions may not be exclusionary at the discretion of the IoR or designee
- •Has a tattoo or other dermatological condition overlying the buttock region which in the opinion of the IoR or designee may interfere with interpretation of ISRs
- •Coagulopathy (primary or iatrogenic) which would contraindicate IM injection
- •Active or planned use of prohibited medications as described in the IB or listed in the SSP Manual (provided by self-report, or obtained from medical history or medical records)
- •Known or suspected allergy to study product components (active or placebo), including egg or soy products (egg and soy products are contained in Intralipid)
- •If potentially able to conceive, unwilling to adhere to long a
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