Bictegravir concentrations and antiviral activity in genital fluids and rectal compartment in HIV-1 infected individuals (BIGER Study”). - BIGER

Fundació Lluita contra la SIDA0 个研究点目标入组 23 人开始时间: 2018年7月17日最近更新: 2020年2月1日

适应症

试验速览

暂无简介。

•1. HIV-1 infected male and female = 18 years of age.
•2. Not previously exposed to ART
•3. Plasma viral load (HIV-1 RNA) at screening >1000 copies/mL
•4. Signed and dated written informed consent prior to inclusion.
•5. 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 23
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Severe hepatic impairment (Child-Pugh Class C)
•2. Ongoing malignancy
•3. Active opportunistic infection
•4. Primary resistance to the study ARV drugs.
•5. Any verified Grade 4 laboratory abnormality
•6. ALT or AST = 3xULN and/or bilirubin = 1.5xULN
•7. Adequate renal function: Estimated glomerular filtration rate = 50 mL/min
•8. Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.

发起方

Fundació Lluita contra la SIDA