NL-OMON55726招募中3 期
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 - GS-US-412-2055
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) HIV-1 negative status
- •2) MSM or TGW (male at birth) who have at least one of the following:
- •a) condomless anal intercourse with at least two unique male partners
- •in the past 12 weeks (partners must be either HIV-infected 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
- •3) Age >= 18 years
- •4) Estimated GFR >= 60 mL/min according to the Cockcroft-Gault formula
- •for creatinine clearance
- •5) Adequate liver and hematologic function
- •6) Willing and able to comply with study procedures
排除标准
- •1) Known hypersensitivity to the IMP, the metabolites, or formulation
- •2) Have a suspected or known active, serious infection(s)
- •3) Acute viral hepatitis A, B or C or evidence of chronic hepatitis B infection.
- •Subjects found to be susceptible to HBV infection should be referred for
- •HBV vaccination. Subjects found to be positive for HCV at screening must not
- •have active infection or must have completed treatment and achieved a sustained
- •virologic response.
- •4) Need for continued use of any contraindicated concomitant
- •medications
- •5) Have an implanted defibrillator or pacemaker
- •6) Have a history of osteoporosis or bone fragility fractures
- •7) Current alcohol or substance abuse judged by the Investigator to be
- •problematic such that it potentially interferes with subject study
- •8) Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or
- •not clinically manageable
- •9) Any other clinical condition or prior therapy that, in the opinion of
- •the Investigator, would make the subject unsuitable for the study or
- •unable to comply with dosing requirements
- •10) Have received investigational agents for the treatment or prevention of
- •HIV-1 infection in the 30 days prior to screening.
- •11) Participation in any other clinical trail (including observational trails)
- •without prior approval from the sponsor is prohibited while participating in
- •this trial.
研究者
相似试验
进行中（未招募）
1 期
A study to compare the safety and effectiveness of F/TAF vs F/TDF (Truvada) once daily for the prevention of HIV, in men and transgender women who have sex with men and are at risk of HIV infectioHealthy volunteers (Pre-exposure prophylaxis (PrEP) of human immunodeficiency virus 1 (HIV-1))MedDRA version: 20.0Level: LLTClassification code 10073527Term: HIV pre-exposure prophylaxisSystem Organ Class: 100000004865EUCTR2016-001399-31-ITGILEAD SCIENCES INCORPORATED5,000
进行中（未招募）
1 期
A study to compare the safety and effectiveness of F/TAF vs F/TDF (Truvada) once daily for the prevention of HIV, in men and transgender women who have sex with men and are at risk of HIV infectioHealthy volunteers (Pre-exposure prophylaxis (PrEP) of human immunodeficiency virus 1 (HIV-1))MedDRA version: 20.0Level: LLTClassification code 10073527Term: HIV pre-exposure prophylaxisSystem Organ Class: 100000004865EUCTR2016-001399-31-NLGilead Sciences, Inc.5,000
进行中（未招募）
1 期
A study to compare the safety and effectiveness of F/TAF vs F/TDF (Truvada) once daily for the prevention of HIV, in men and transgender women who have sex with men and are at risk of HIV infectioHealthy volunteers (Pre-exposure prophylaxis (PrEP) of human immunodeficiency virus 1 (HIV-1))MedDRA version: 20.0Level: LLTClassification code 10073527Term: HIV pre-exposure prophylaxisSystem Organ Class: 100000004865EUCTR2016-001399-31-ATGilead Sciences, Inc.5,000
进行中（未招募）
1 期
A study to compare the safety and effectiveness of F/TAF vs F/TDF (Truvada) once daily for the prevention of HIV, in men and transgender women who have sex with men and are at risk of HIV infectioHealthy volunteers (Pre-exposure prophylaxis (PrEP) of human immunodeficiency virus 1 (HIV-1))MedDRA version: 19.0Level: LLTClassification code 10073527Term: HIV pre-exposure prophylaxisSystem Organ Class: 100000004865EUCTR2016-001399-31-FRGilead Sciences, Inc.5,000
进行中（未招募）
1 期
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.Cis-eligible Muscle-invasive bladder cancer.MedDRA version: 21.1Level: LLTClassification code: 10022877Term: Invasive bladder cancer Class: 10029104MedDRA version: 21.0Level: LLTClassification code: 10022879Term: Invasive bladder cancer stage III Class: 10029104MedDRA version: 21.0Level: LLTClassification code: 10022878Term: Invasive bladder cancer stage II Class: 10029104CTIS2022-501970-20-01Merck Sharp & Dohme LLC912