A Phase II, randomized clinical trial to assess the impact of antiretroviral therapy over viral load in seminal fluid in antiretroviral-naive HIV-positive patients

INTERVENTION: 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 Concentration number: 245‐ INN or Proposed INN: EMTRICITABINE CAS Number: 143491‐57‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ INN or Proposed INN: RILPIVIRINE HYDROCHLORIDE CAS Number: 700361‐47‐3 Other descriptive name: RILPIVIRINE HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Trade Name: STRIBILD Pharmaceutical Form: Tablet INN or Proposed INN: TENOFOVIR DISOPROXIL Other descriptive name: TENOFOVIR DISOPROXIL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 245‐ INN or Proposed INN: EMTRICITABINE CAS Number: 143491‐57‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ INN or Proposed INN: ELVITEGRAVIR CAS Number: 697761‐98‐1 Other descriptive name: ELVITEGRAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ INN or Proposed INN: cobicistat CAS Number: 1004316‐88‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Trade Name: TRUVADA Pharmaceutical Form: Tablet INN or Proposed INN: EMTRICITABINE CAS Number: 143491‐57‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ INN or Proposed INN: TENOFOVIR DISOPROXIL Other descriptive name: TENOFOVIR DISOPROXIL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 245‐ Trade Name: PREZISTA Pharmaceutical Form: Tablet INN or Proposed INN: DARUNAVIR ETHANOLATE CAS Number: 635728‐49‐3 Other descriptive name: DARUNAVIR ETHANOLATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 800‐ Trade Name: NORVIR Pharmaceutical Form: Tablet INN or Proposed INN: RITONAVIR CAS Number: CONDITION: 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 Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] SECONDARY OUTCOME: 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 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 <100.000 copies/mL of plasma 5. CD4 count ?200/?l 6. No genotyping resistance for studies drugs 7. Signed informed consent form (ICF) executed prior to protocol screening assessments 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 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range PRIMARY OUTCOME: 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) Primary end point(s): RNA‐HIV load in peripheral blood and seminal fluid 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 Timepoint(s) of evaluation of this end point: At week 12