A PHASE III MULTICENTER, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE A SWITCH TO MK-1439A IN HIV-1-INFECTED SUBJECTS VIROLOGICALLY SUPPRESSED ON A REGIMEN OF A RITONAVIR-BOOSTED PROTEASE INHIBITOR AND TWO NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTIS)

Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,0 个研究点目标入组 7 人开始时间: 2016年1月11日最近更新: 2024年3月12日

试验速览

暂无简介。

•1 At least 18 years of age
•2 Provide written informed consent
•3 Have plasma HIV-1 RNA levels BLoQ (<40 copies/mL)
•4 Have been receiving antiretroviral therapy with atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir in combination with 2 NRTIs continuously with HIV-1 RNA at undetectable levels for ≥ 6 months prior to visit 1and have no history of prior virologic failure.
•5 Be receiving 1st or 2nd PI-based antiretroviral regimen
•6 No history of using NNRTI
•7 Have a genotype prior to starting initial antiretroviral regimen and have no known resistance to any of the study agents
•8 Either no lipid lowering therapy or on a stable dose of lipid lowering therapy
•9 Have stable/normal laboratory values
•11 Clinically stable
•12 Highly unlikely to become pregnant or to impregnate a partner

•1 History or current evidence of any condition, therapy, laboratory abnormality.
•2 Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
•3 Has been treated for a viral infection other than HIV-1, with an agent that is active against HIV-1.
•4 Has documented or known resistance to study drugs.
•5 Has participated in a study with an investigational compound/device.
•6 Has used systemic immunosuppressive therapy or immune modulators.
•7 Requires using any of the prohibited medications.
•8 Has significant hypersensitivity or other contraindication to any of the components of study drugs.
•9 Has a current (active) diagnosis of acute hepatitis due to any cause.
•10 Is pregnant, breastfeeding, or expecting to conceive.
•11 Is expecting to donate eggs or sperm.
•12 Is or has an immediate family member who is investigational site or sponsor staff directly involved with this trial.

发起方

Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,