This open label trial will recruit patients with HIV who are already receiving anti-HIV treatment which includes ritonavir and emtricitabine/tenofovir disoproxil fumurate (Truvada). Patients will remain on the same anti-HIV drugs as prior to the study (ritonavir and Truvada)or switch to receive an investigational single tablet regimen (EVG/COBI/FTC/TDF).

Conditions: Human Immunodeficiency Virus (HIV-1) Infections
MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2011-004483-30-IT

Lead Sponsor: GILEAD SCIENCE INC.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 420

Inclusion Criteria

Age = 18 years. - Be on a stable antiretroviral regimen consisting of a ritonavir boosted PI plus FTC/TDF continuously for = 6 consecutive months preceding the screening visit. - Documented undetectable plasma HIV-1 RNA levels (according to the local assay being used) for = 6 months preceding the screening visit (measured at least twice). - Be on the first or second antiretroviral drug regimen; if on the second regimen, must not have had HIV-1 RNA above detectable levels (according to the local assay being used) at the time of change in antiretroviral drugs nor ever experienced two consecutive HIV-1 RNA above detectable levels(according to the local assay being used) after first achieving a confirmed HIV-1 RNA below detectable levels. - Documented historical genotype prior to starting initial antiretroviral therapy showing no known resistance to TDF or FTC, including, but not limited to the presence of reverse transcriptase resistance mutants K65R, M184V/I, or 3 or more thymidine analog-associated mutations (M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R). - No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time. - HIV RNA < 50 copies/mL at the screening visit. - Estimated glomerular filtration rate = 90 mL/min according to the Cockcroft-Gault formula at the screening visit.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 378
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

- A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4 cell count and/or percentage criteria). - Females who are breastfeeding. - Positive serum pregnancy test (female of childbearing potential). - Receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study. -Experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.). - Have an implanted defibrillator or pacemaker. - Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance. - A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline and must not be anticipated to require systemic therapy during the study. - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline, except for intramuscular penicillin for the treatment of syphilis. - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study. - Subjects receiving ongoing therapy with any of the medications in the table listed in the Study Protocol, including drugs not to be used with EVG, COBI, FTC, TDF; or subjects with any known allergies to the excipients of EVG/COBI/FTC/TDF tablets, or Truvada tablets. - No anticipated need to initiate drugs during the study that are contraindicated. - Receiving other investigational drugs. - Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial. - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the non-inferiority of EVG/COBI/FTC/TDF relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI/r) plus FTC/TDF in maintaining HIV-1 RNA < 50 copies/mL at Week 48 (Snapshot Analysis) in virologically suppressed, HIV-1 infected subjects.;Secondary Objective: - To evaluate the change in CD4 cell count. - To evaluate the safety and tolerability of the regimens.;Primary end point(s): The primary efficacy endpoint is the proportion of subjects who have HIV-1 RNA < 50 copies/mL as defined by the FDA snapshot analysis.;Timepoint(s) of evaluation of this end point: 48 weeks

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1. The safety and tolerability of each treatment arm over 48 weeks, namely at baseline, 4, 8, 12, 24, 36 and 48 weeks. 2. The change from baseline in CD4 cell count in each treatment arm at 48 weeks.;Secondary end point(s): 1. The safety and tolerability of each treatment arm by assessing adverse events and clinical laboratory tests (haematology, chemistry and urinalysis). 2. The change from baseline in CD4 cell count in each treatment arm.