A Randomized, Double-Blind, Placebo-Controlled, Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Orally Administered Capsid Inhibitors in HIV-1 Infected Treatment-Naïve Adults - 218307

Viiv Healthcare UK Limited0 个研究点目标入组 43 人开始时间: 2023年8月11日最近更新: 2024年7月22日

适应症

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•Are 18 to 65 years of age, Are overtly healthy (other than HIV-1 infection), Have screening CD4+ T-cell counts >=200 cells/µL., Have documented HIV-1 infection and Screening plasma HIV-1 RNA >=3000 copies/mL, Are treatment-naïve: Prior use of oral PreP is permitted and meets inclusion. Prior use of parenteral PreP is exclusionary, Has BMI within the range 18.5-31.0 kg/m2., Participants male at birth must use male condoms and participants female at birth who are of childbearing potential must be using acceptable forms of birth control, Are capable of giving signed informed consent, Are willing and able to start locally accessible and commercially available combination antiretroviral therapy on Study Day 11.

•Are breastfeeding or plan to become pregnant or breast feed during the study., Has untreated syphilis infection., Is positive for hepatitis B or hepatitis C., Has exclusionary safety laboratory (e.g Grade 3 or greater abnormality)., Is positive result for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use, Participants with acute HIV infection, Any evidence of an active CDC Stage 3 disease., Ongoing malignancy other than certain localized malignancies, Treatment with immunomodulating agents or any agent with known anti-HIV activity., Has exclusionary psychiatric, hepatic, cardiovascular gastrointestinal, renal condition, Has a condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take the medication., Has an exclusionary ECG finding., Has been exposed to any prohibited medication or vaccine.

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