A study involving an experimental combination medicationcalled EVG/COBI/FTC/TDF. The single tablet contains 3 experimentalmedications, EVG and COBI and TAF, plus 1 medication already approved for the treatment of HIV-1 infection, FTC. In this study neither the patient or the investigator will know whether the patient is receiving EVG/COBI/FTC/TAF or the comparator drug EVG/COBI/FTC/TDF. This is a randomized (by chance, like a flip of a coin) study.

Phase 1

Conditions: Human Immunodeficiency Virus (HIV-1) Infection
MedDRA version: 19.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2013-000102-37-NL

Lead Sponsor: Gilead Sciences Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 872

Inclusion Criteria

• The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
• Plasma HIV-1 RNA levels = 1,000 copies/mL at screening
• No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for PREP (pre-exposure prophylaxis) or PEP (post-exposure prophylaxis), up to 6 months prior to screening.
• Screening genotype report must show sensitivity to EVG, FTC and TDF
• Normal ECG
• Estimated GFR = 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
• Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug.
• Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
• Female subjects who have stopped menstruating for = 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range.
• Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from screening throughout the study period and for 30 days following discontinuation of investigational medicinal product.
• Age = 18 years

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 788
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

Exclusion Criteria

• A new AIDS-defining condition diagnosed within the 30 days prior to screening
• Hepatitis B surface antigen (HBsAg) positive
• Hepatitis C antibody positive
• Subjects experiencing decompensated cirrhosis
• Females who are breastfeeding
• Positive serum pregnancy test
• Have an implanted defibrillator or pacemaker
• Current alcohol or substance use
• A history of malignancy within the past 5 years (prior to screening)
• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
• 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 dosing requirements.
• Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial.
• Subjects receiving ongoing therapy with any of the medications contraindicated in the protocol, including drugs not to be used with EVG, COBI, FTC, TDF, and TAF (refer to
the individual agents Prescribing Information); or subjects with any known allergies to
the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets.