2024-511041-19-00已完成2 期
A Phase 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir (ISL) and MK-8507 Once-Weekly in Adults with HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once-Daily
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Percentage of participants with ≥1 adverse event (AE)
研究概览
简要总结
To evaluate the safety and tolerability of ISL + MK-8507 once-weekly as assessed by review of the accumulated safety data.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening
- •Has been virologically suppressed on BIC/FTC/TAF for ≥6 months
- •Has a screening CD4+ T-cell count >200 cells/mm^3 (completed by the central laboratory)
- •Is male or female, at least 18 years of age, at the time of signing the informed consent
- •Female participants are eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) is not a woman of childbearing potential (WOCBP), or b) is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis)
排除标准
- •Has HIV-2 infection
- •Is female and expecting to conceive or donate eggs at any time during the study
- •Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- •Has active hepatitis C virus (HCV) coinfection (defined as detectable HCV RNA) or hepatitis B virus (HBV) coinfection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive)
- •Has a current (active) diagnosis of acute hepatitis due to any cause
- •Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
- •Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use 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
- •Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
- •Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period
- •Has a documented or known virological resistance to ulonivirine or nucleoside/nucleotide reverse transcriptase inhibitors (NNRTI)
研究组 & 干预措施
islatravir
Experimental
Participants receiving islatravir
干预措施: islatravir (Drug)
ulonivirine
Experimental
Participants receiving ulonivirine
干预措施: ulonivirine (Drug)
结局指标
主要结局
Percentage of participants with ≥1 adverse event (AE)
Percentage of participants with ≥1 adverse event (AE)
Percentage of participants discontinuing study intervention due to AE
Percentage of participants discontinuing study intervention due to AE
次要结局
- NA
研究者
Wayne Greaves
Scientific
Merck Sharp & Dohme LLC
研究点 (3)
Loading locations...
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