HIV-1 infection MedDRA version: 17.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: EVIPLERA
Pharmaceutical Form: Tablet
INN or Proposed INN: TENOFOVIR DISOPROXIL
Other descriptive name: TENOFOVIR DISOPROXIL
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Fundación pública andaluza para la gestión de la investigación en salud de Sevilla (FISEVI)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male with HIV-1 infection 2. 18 Years and older 3. Antiretroviral-naïve 4. Plasmatic viral load plasma HIV-1 viral load: RNA ?1.000 y =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence or history of genotyping resistance for studies drugs 2. Oportunistic infections or malignancy disease 3. Symthoms of sexually transmitted disease 4. Co-infection with HBV or HIV (positive test for HBsAg or anti-HIV Ab); 5. Liver cirrhosis Child-Pugh score B or C . 6. Laboratory results upper limit of the normal range grade 3 or 4 ( AIDS Clinical Trials Group) 7. Serum estimated Glomerular Filtration Rate (eGFR) <70 ml/min. 8. No treatment adherence 9. Unable to commit with the study visits 10. Withdrawal of Signed informed consent form (ICF)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare viral kinetic (decreasing in RNA-HIV-1) in seminal fluid in atiretroviral-naïve HIV-1 patients who start antiretroviral therapy with Tenofovir + Emtricitabina and a three-drug combination: ritonavir boosted protease inhibitor (such as Darunavir/ritonavir) or non-nucleoside reverse-transcriptase inhibitor (such as Rilpivirina) or integrase inhibitor plus inhibitor of cytochrome P450 (such as Elvitegravir/cobicistat);Secondary Objective: 1.- Rate of patients with undetectable viral load in seminal fluid at week 24. 2.- To study dinamics differences in HIV-1 reservoirs (DNA-HIV) in peripheral blood mononucleated cells (PBMCs) and in seminal non spermatics mononucleated cells (SMCs) , in relation with diferents regimen drugs 3.- To determine plasma concentrations of the third-drug combination in both compartiments (peripheral blood and seminal fluid), and their hipothetical relation between drugs levels and viral cinetic. 4- Study drugs safety throug the aseessment and evaluation of adverse events communication from informed consent form signature to end of follow-up;Primary end point(s): RNA-HIV load in peripheral blood and seminal fluid;Timepoint(s) of evaluation of this end point: At week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.- Rate of patients with undetectable viral load in seminal fluid at week 24. 2.- To study dinamics differences in HIV-1 reservoirs (DNA-HIV) in peripheral blood mononucleated cells (PBMCs) and in seminal non spermatics mononucleated cells (SMCs) , in relation with diferents regimen drugs 3.- To determine plasma concentrations of the third-drug combination in both compartiments (peripheral blood and seminal fluid), and their hipothetical relation between drugs levels and viral kinetic. 4- Study drugs safety throug the aseessment and evaluation of adverse events communication from informed consent form signature to end of follow-up;Timepoint(s) of evaluation of this end point: At week 24 | — |
Countries
Spain
Contacts
Public ContactClara M. Rosso
Fundación pública andaluza para la gestión de la investigación en salud de Sevilla (FISEVI)
Outcome results
None listed