PER-107-20尚未招募未知
A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL ISLATRAVIR ONCE-MONTHLY AS PREEXPOSURE PROPHYLAXIS IN CISGENDER MEN AND TRANSGENDER WOMEN WHO HAVE SEX WITH MEN, AND ARE AT HIGH RISK FOR HIV-1 INFECTIO
Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,0 个研究点目标入组 0 人开始时间: 2021年2月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1.Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization. Note: If a positive result is obtained for any HIV test prior to randomization, the participant is not eligible for the study. Additional testing to confirm suspected HIV infection during screening will be performed in accordance with local guidelines. If HIV infection is confirmed, participants will be referred for appropriate care, as necessary.
- •2.Is sexually active with male (assigned male sex at birth) or transgender female partners defined as having anal sexual intercourse with a man or TGW at least once in the past month.
- •3.Is at high risk for sexually acquiring HIV-1 infection based on self-report of at least 1 of the following:
- •Condomless receptive anal intercourse in the 6 months prior to screening occurring outside a mutually monogamous HIV seronegative concordant relationship.
- •More than 5 partners (anal intercourse) in the 6 months prior to screening (regardless of condom use and HIV serostatus, as reported by the enrollee).
- •Any unprescribed stimulant drug use in the 6 months prior to screening.
- •Rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening.
- •4.Is cisgender male or transgender female (assigned male sex at birth), and ≥16 years of age at the time of providing informed consent/assent.
- •5.The participant (or legally acceptable representative) has provided documented informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
- •6.Has no plans to relocate or travel away from the site for ≥4 consecutive weeks during study participation.
排除标准
- •1.Has hypersensitivity or other contraindication to any component of the study interventions as determined by the investigator.
- •2.Has active HBV infection (defined as HBsAg-positive or HBV DNA positive). Note: Past HBV infection or previous HBV vaccination (defined as HBsAg-negative and positive for antibody against HBsAg) is not an exclusion criterion. Participants who do not demonstrate immunity to HBV are encouraged to be vaccinated against HBV.
- •3.Has known current or chronic history of liver disease (eg, nonalcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert´s syndrome, asymptomatic gallstones, or cholecystectomy), unless the participant has stable liver function tests and no evidence of hepatic synthetic dysfunction. Note: Hepatic synthetic dysfunction is defined as a serum albumin <2.8 g/dL or an INR >1.7 in the absence of another explanation for the abnormal laboratory value.
- •4.Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer or in situ anal cancers.
- •5.Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol abuse or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to enroll.
- •6.Has taken cabotegravir at any time (past or current).
- •7.Is currently receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the duration of the study. Note 1: Participants taking FTC/TDF or FTC/TAF for PrEP at screening may contin Note 2: Any prior or current HIV-1 PrEP medications taken by the participant, regardless of timing, are to be recorded as prior medications.ue their regimen until the day of randomization.
- •8.Is currently participating in or has participated in an interventional or prevention clinical study with an investigational compound or device, including HIV-1 prevention compounds or devices, within 30 days prior to Day 1 through the duration of the study.
- •9.Has exclusionary laboratory values within 45 days prior to Day 1. Note: A single repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results, but the repeat test results must be available within the 45-day screening window.
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