Bictegravir concentrations and antiviral activity in genital fluids and rectal compartment in HIV-1 infected individuals (BIGER Study”).
- Conditions
- HIV-1 infected male and female adults not previously exposed to ART.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2018-002310-12-ES
- Lead Sponsor
- Fundació Lluita contra la SIDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 23
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method