Study to determine the Elvitegravir concentrations in semen in HIV-1 infected patients (?ELVIs Study?)

Conditions: HIV-1 positive patients
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2013-005116-10-ES

Lead Sponsor: Dr. Daniel Podzamczer Palter (Unidad de VIH. Servicio de Enfermedades Infecciosas. Hospital de Bellvitge).

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 10

Inclusion Criteria

1. HIV-1 infected men ? 18 years of age.
2. Be on a stable ART consiting of TDF/FTC or ABC/3TC plus 1 NNRTI, 1 boosted PI or raltegravir, continously for ? 6 consecutive months preceding the screening visit.
3. HIV-1 RNA VL<50 c/mL for at least 6 months before switching to EVG/COB/FTC/TDF (Stribild®) 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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Severe hepatic insufficiency (Child-Pugh Class C)
2. Ongoing malignancy
3. Active opportunistic infection
4. Primary resistance to any of the ARV included in the study (genotypes without evidence of TDF (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.
5. Any verified Grade 4 laboratory abnormality
6. ALT or AST ? 3xULN and/or bilirubin ? 1.5xULN
7. Estimated creatinine clearance <70mL/min

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To determine elvitegravir concentrations in seminal plasma in HIV-1 infected subjects receiving treatment with Elvitegravir 150 mg /cobicistat 150 mg /emtricitabine 200 mg /tenofovir disoproxil fumarate 300 mg (Stribild®).;Secondary Objective: - To compare elvitegravir concentrations in seminal plasma and blood plasma.<br>- To determine HIV-1 RNA in seminal plasma<br>- To compare HIV-1 RNA in seminal plasma and blood;Primary end point(s): Elvitegravir concentrations (ng/mL) in seminal plasma 4 weeks after switching to Elvitegravir /cobicistat /emtricitabine /tenofovir disoproxil fumarate (Stribild®).;Timepoint(s) of evaluation of this end point: 4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Elvitegravir concentrations in plasma<br>- Elvitegravir concentration Semen/Plasma ratio<br> - HIV-1 RNA in seminal plasma <br>- HIV-1 RNA in plasma;Timepoint(s) of evaluation of this end point: 4 weeks