Bictegravir concentrations and antiviral activity in cerebrospinal fluid in HIV-1 Infected individuals - BICS

Fundació Lluita contra la SIDA0 个研究点目标入组 15 人开始时间: 2018年4月9日最近更新: 2018年11月26日

试验速览

暂无简介。

•- Asymptomatic, HIV-1 infected individuals = 18 years of age
•- Be on a stable ART consisting of TDF/FTC or ABC/3TC plus 1NNRTI, 1 boosted PI or 1 integrase inhibitor, continously or =3 consecutive months preceding the screening visit. Patients already receiving TAF/FTC/BIC for at least three consecutive months will be eligible.
•- Plasma HIV-1 RNA at screening <40 copies/mL for at least 6 months at the Screening visit.
•- Signed and dated written informed consent prior to inclusion.
•- Subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study.
•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 15
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Severe hepatic impairment (Child-Pugh Class C)
•- Ongoing malignancy
•- Active opportunistic infection
•- Primary resistance to any of the ARV included in the study or history of virologic failure with risk of resistance selection to any of the study drugs.
•- Any verified Grade 4 laboratory abnormality
•- ALT or AST = 3xULN and/or bilirubin = 1.5xULN
•- Adequate renal function: Estimated glomerular filtration rate = 50 mL/min
•- Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.
•- Current treatment with antiaggregant or anticoagulant therapy.
•- History of any neurologic disease/condition/treatment may alter the blood brain barrier permeability.

发起方

Fundació Lluita contra la SIDA