A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are At Risk of HIV-1 Infection.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,090
- 试验地点
- 21
- 主要终点
- The primary endpoint will be the incidence of HIV-1 infection per 100 person years (PY) when all participants have a minimum follow up of 48 weeks and at least 50% of the participants have 96 weeks of follow up after randomization. HIV-1 infection is defined by 1 or more of the following criteria of contributing HIV tests performed via central lab or local lab:
研究概览
简要总结
To assess the rates of HIV-1 infection in men who have sex with men (MSM) and transgender women (TGW) who have sex with men who are administered daily F/TAF or F/TDF with a minimum follow up of 48 weeks and at least 50% of participants have 96 weeks of follow up after randomization
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •HIV-1–negative status
- •MSM or TGW (male at birth) who have at least one of the following: a) condomless anal intercourse with at least 2 unique male partners in the past 12 weeks (partners must be either PWH or of unknown HIV status) b) documented history of syphilis in the past 24 weeks c) documented history of rectal gonorrhea or chlamydia in the past 24 weeks
- •Age ≥ 18 years
- •Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min according to the Cockcroft-Gault formula for creatinine clearance {Cockcroft 1976}: (140 ― age in years) × (wt in kg) / 72 × (serum creatinine in mg/dL) = CLcr(mL/min)
- •Adequate liver and hematologic function: • AST and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin • Absolute neutrophil count ≥ 1000/mm3, platelets ≥ 75,000/mm3, and hemoglobin ≥ 10 g/dL
- •Willing and able to comply with study procedures
排除标准
- •Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
- •Have received investigational agents for the treatment or prevention of HIV-1 infection in the 30 days prior to screening
- •Participation in any other clinical study (including observational studies) without prior approval from the sponsor is prohibited while participating in this study
- •Have a suspected or known active, serious infection(s)
- •Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B infection. Participants found to be susceptible to hepatitis B virus (HBV) infection should be referred for HBV vaccination. Participants found to be positive for hepatitis C virus (HCV) at screening must not have active infection or must have completed treatment and achieved a sustained virologic response.
- •Need for continued use of any contraindicated concomitant medications
- •Have an implanted defibrillator or pacemaker
- •Have a history of osteoporosis or bone fragility fractures
- •Current alcohol or substance abuse judged by the investigator to be problematic such that it potentially interferes with participant study compliance
- •Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable.
- •Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements
结局指标
主要结局
The primary endpoint will be the incidence of HIV-1 infection per 100 person years (PY) when all participants have a minimum follow up of 48 weeks and at least 50% of the participants have 96 weeks of follow up after randomization. HIV-1 infection is defined by 1 or more of the following criteria of contributing HIV tests performed via central lab or local lab:
The primary endpoint will be the incidence of HIV-1 infection per 100 person years (PY) when all participants have a minimum follow up of 48 weeks and at least 50% of the participants have 96 weeks of follow up after randomization. HIV-1 infection is defined by 1 or more of the following criteria of contributing HIV tests performed via central lab or local lab:
Serologic evidence of seroconversion (reactive screening HIV antigen [Ag]/antibody [Ab] or Ab test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or
Serologic evidence of seroconversion (reactive screening HIV antigen [Ag]/antibody [Ab] or Ab test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or
Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or
Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or
Evidence of acute HIV-1 infection (reactive p24 Ag or positive qualitative or quantitative RNA, in the absence of a reactive HIV-1 Ab test results)
Evidence of acute HIV-1 infection (reactive p24 Ag or positive qualitative or quantitative RNA, in the absence of a reactive HIV-1 Ab test results)
次要结局
- The percent change from baseline in hip BMD at Week 48 in a subset of participants
- The percent change from baseline in spine BMD at Week 48 in a subset of participants
- Assessment of renal biomarkers at Week 48
- Percent change from baseline in urine beta-2-microglobulin to creatinine ratio
- Percent change from baseline in urine RBP to creatinine ratio
- Distribution of UP and UPCR categories
- The change from baseline in serum creatinine at Week 48
- The incidence of HIV-1 infection (as per Appendix 11.6) per 100 PY when all participants have 96 weeks of follow up after randomization
- The percent change from baseline in hip and spine BMD at Week 96 in the blinded phase in a subset of participants
- Assessment of renal biomarkers at Week 96 in the blinded phase
- The change from baseline in serum creatinine at Week 96 in the blinded phase
- The incidence of treatment-emergent adverse events (AEs) and laboratory toxicities
研究者
EU Clinical Trials Support
Scientific
Gilead Sciences Inc.