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

Elvitegravir concentrations in seminal plasma in HIV-1 infected patients (?ELVIs Study?) - ELVIs

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005116-10-ES

Enrollment

Registered

2014-02-07

Start date

2014-04-10

Completion date

Unknown

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 positive patients

Interventions

Trade Name: Stribild Product Name: Stribild Pharmaceutical Form: Tablet INN or Proposed INN: ELVITEGRAVIR CAS Number: 697761-98-1 Other descriptive name: ELVITEGRAVIR Concentration unit: mg milligram(

Eligibility

Sex/Gender

Male

Inclusion criteria

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=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. - To determine HIV-1 RNA in seminal plasma - 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	—

Measure

Time frame

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. - To determine HIV-1 RNA in seminal plasma - 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

Measure	Time frame
Secondary end point(s): - Elvitegravir concentrations in plasma - Elvitegravir concentration Semen/Plasma ratio - HIV-1 RNA in seminal plasma - HIV-1 RNA in plasma;Timepoint(s) of evaluation of this end point: 4 weeks	—

Countries

Spain

Contacts

Public ContactDr. Arkaitz Imaz

Unidad de VIH. Servicio de Enfermedades Infecciosas.Hospital de Bellvitge

aimaz@bellvitgehospital.cat0034932607667

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026