Tenofovir DP concentrations in seminal cells and semen quality in HIV-1 infected patients receiving a TAF containing regime
- Conditions
- HIV-1 positive patientsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2016-001371-69-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
- 15
1. HIV-1 infected men = 18 years of age.
2. Be on a stable ART consisting on TDF/FTC/EVG/COBI continously for = 3 month preceeding the screening visit.
3. HIV-1 RNA VL<40 c/mL for at least 6 months before switching to TDF/FTC/EVG/COBI and at the Screening visit.
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 throught 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
1. Ongoing malignancy.
2. Active opportunistic infection.
3. Primary resistance to any of the ARV included in the study (genotypes without evidence of tenofovir (K65R, 3 or more TAMs including M41L, L210W), FTC (M184V/I), and EVG-associated mutations) or history of virologic failure with risk of resistance selection to any of the study drugs.
4. Chronic HBV hepatitis.
5. Any verified Grade 4 laboratory abnormality.
6. ALT or AST = 3xULN and/or bilirubin = 1.5xULN.
7. Severe renal impairment (Estimated creatinine clearance <50mL/min).
8. Severe hepatic impairment (Child-Pugh Class C).
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