EUCTR2020-003309-79-Outside-EU/EEA进行中（未招募）1 期
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 Infection - Oral ISL QM as PrEP in MSM and TGW at High Risk for HIV-1 Infection
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization.
- •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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1399
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Has hypersensitivity or other contraindication to any component of the study interventions as determined by the investigator.
- •2. Findings of chronic HBV (HBsAg-positive) or past HBV (HBsAg-negative and HBcAb-positive) infection which could indicate risk for hepatitis B reactivation.
- •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.
- •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, lenacapavir, or any other long-acting HIV prevention product at any time (past or current).
- •7. Is currently receiving or is anticipated to require any prohibited therapies outlined in the protocol from 30 days prior to Day 1 through the duration of the study.
- •8. Is currently participating in or has participated in an interventional or prevention clinical study with an investigational compound or device 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.
研究者
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