Safety, tolerability, and efficacy of a dose reduction strategy based on bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed HIV-infected adults.

Institut d’Investigacions Biomèdiques August Pi i Sunyer0 个研究点目标入组 40 人开始时间: 2022年3月8日最近更新: 2022年5月16日

适应症

试验速览

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•1) Stable and asymptomatic HIV-infected adults (=18 years) on BETAF once daily for at least the previous 6 months.
•2) Plasma HIV-1 RNA less than 50 copies/mL for at least the previous 6 months
•3) CD4 cell counts greater than 350 cells/mL at the time of consideration for the study
•4) Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods
•5) Patients agreed to participate
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1) Prior virological failure to any antiretroviral regimen or documented resistance mutations to bictegravir, emtricitabine, or tenofovir
•2) Any diagnosis of psychiatric illness
•3) Alcohol abuse or illicit drug consumption (based on their past medical history and specific questions at the time of recruitment)
•4) Patients co-infected with HIV and active hepatitis B or C virus
•5) Any other condition at the doctor's discretion that did not allow ensuring a correct adherence.

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