Switching At Low HIV-1 RNA Into Fixed Dose Combinations

Janssen-Cilag International NV0 个研究点目标入组 426 人开始时间: 2012年10月19日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Documented human immunodeficiency virus-type 1 (HIV-1) infection
•- Patients who have been receiving first line highly active antiretroviral therapy (HAART) for at least 1 year before the screening visit
•- Patients who prefer to change the current HAART regimen for reasons of simplification and/or due to toxicity of nucleoside/nucleotide reverse transcriptase inhibitor (N[t]RTI)
•- Antiretroviral (ARV) combination treatment for at least 8 weeks before the screening visit and expected to continue on the same regimen throughout the screening period
•- Plasma HIV-1 RNA less than 50 copies per mL and cluster of differentiation 4 positive (CD4+) cell count more than 200 per cubic millimeter
•- Agrees to protocol-defined use of effective contraception

•- History of virologic failure (2 consecutive plasma HIV-1 ribonucleic acid (RNA) more than or equal to 400 copies per mL) and immunologic failure (2 consecutive CD4+ cell counts) while on previous or current ART
•- History of any primary N[t]RTI or NNRTI mutations below the pre HAART level
•- Significantly decreased hepatic function or hepatic insufficiency or diagnosed with acute clinical viral hepatitis
•- Diagnosed with Mycobacterium tuberculosis infection
•- Severe laboratory abnormalities
•- Creatinine clearance less than 50 mL per minute
•- Addicted to drug, including alcohol or recreational drugs

发起方