CTIS2023-505780-37-00招募中1 期
A Randomized, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Adaptive Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in Treatment-Naïve Adults Living with HIV-1 - 212580
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 28
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participants aged 18 to 65 years of age inclusive at the time of signing the informed consent, Participant must be willing and able to start a commercially available standard of care antiretroviral treatment regimen on Study Day 8 ., Participants who are overtly healthy (other than HIV infection), Screening CD4+ T-cell count >=200 cells/mm3, Documented HIV infection and Screening plasma HIV-1 RNA >=3000 and <1,000,000 copies/mL., Positive HIV antibody test, Treatment naive: No antiretroviral therapies (in combination or monotherapy) received after HIV-1 diagnosis, Body weight =50.0 kg (110 lbs.) for men and =45.0 kg (99 lbs) for women and BMI for all participants within the range 18.5-35.0 kg/m2, Participants who were considered female at birth must be of non-childbearing potential, Capable of giving signed informed consent
排除标准
- •Any evidence of an active CDC Stage 3 disease, Medical history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome or sudden cardiac death. Has an exclusionary ECG finding., Previous exposure to a maturation inhibitor, Has been exposed to any prohibited or exclusionary medication or vaccine., History of sensitivity to any of the study interventions or their components., Exposure to an experimental medication or vaccine within 28 days or 5 half-lives (which is longer) before the first dose of study intervention., Has untreated syphilis infection, Is positive for Hepatitis B or C, Has exclusionary safety laboratory test results (e.g., Grade 3 or greater abnormality), Has a positive result for illicit drug use, regular use of drugs of abuse, Sensitivity to heparin or heparin-induced thrombocytopenia, Ongoing malignancy other than certain localized malignancies, History of significant underlying psychiatric disorder or a clinical assessment of suicidality. History of suicidal behavior and/or ideation should be considered when evaluating suicide risk, History of major depressive disorder with or without suicidal features, or anxiety disorders that required medical intervention., Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse) which may interfere with participant's ability to comply with the protocol and dosing schedule, Current or chronic history of liver disease, Primary HIV infection, Pre-existing condition that could interfere with normal gastrointestinal anatomy or motility, hepatic and/or renal function that could impact the absorption, metabolism, and/or excretion of the study interventions., Myocardial infarction, acute coronary syndrome, unstable angina, stroke, TIA, or intermittent claudication in the past 3 months.
研究者
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