Open-Label Study with Rilpivirine in Treatment-naÃ¯ve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy - RISE

Johnson Johnson Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Must have documented human immunodeficiency virus type 1 (HIV-1) infection
•2. Must be antiretroviral (ARV) treatment-naÃ¯ve
•3. Have plasma HIV-1 ribonucleic acid (RNA) less than 100,000 copies/milliliter (mL) at screening visit
•4. Have cluster of CD4+ T-cell count (greater than) 200/ cubic millimeter (mm3) at screening visit
•5. Women of childbearing potential must have a negative serum (beta human chorionic gonadotropin [beta hCG]) pregnancy test at screening; and a negative urine (or serum, if required by local regulations) pregnancy test before the first dose of study

•1. History of any primary nucleo(t)side reverse transcriptase inhibitor (N[t]RTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations (if testing performed locally, and results are available), as defined by the current International AIDS (acquired immunodeficiency syndrome) Societyâ??United States (USA) (International Antiviral Society-USA) 2017 guidelines
•2. Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (hepatic insufficiency)
•3. Diagnosed with acute viral hepatitis at screening or before baseline
•4. Infected with Mycobacterium tuberculosis which is likely to require rifampicin based treatment during the study
•5. Has a Grade 3 or 4 laboratory abnormality as defined by the Division of AIDS (DAIDS) for Grading the Severity of Adult and Pediatric Adverse Events criteria with the following exceptions unless clinical assessment foresees an immediate health risk to the participant: (a) Preexisting diabetes or with asymptomatic glucose Grade 3 or 4 elevations (b) Asymptomatic triglyceride or cholesterol elevations of Grade 3 or 4

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