Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I

Inclusion Criteria

• •Documented historical genotype report showing mutation M184V and/or M184I (mixtures are acceptable) in reverse transcriptase. Individuals must not have any primary integrase strand transfer inhibitor (INSTI) or primary protease inhibitor (PI) resistance mutations present on historical genotype; non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations are allowed.
• •Proviral deoxyribonucleic acid (DNA) test must not have additional exclusion resistance mutations against PIs, NRTIs and INSTIs
• •* Part 1: Historical genotype report must show mutation M184V and/or M184I in reverse transcriptase WITHOUT any other NRTI resistance mutation (including thymidine analogue-associated mutations \[TAMs\] \[TAMs are: M41L, D67N, K70R, L210W, T215Y/F, and K219Q/E/N/R\], K65R, K70E, T69 insertion, and Q151M mutation complex \[A62V, V75I, F77L, F116Y, Q151M\])
• •* Part 2 (after the interim efficacy review): Historical genotype report must show M184V and/or M184I in reverse transcriptase WITH or WITHOUT 1 or 2 TAMs. Evidence of K65R, K70E, T69 insertion and/or Q151M mutation complex will not be eligible
• •Currently receiving an ARV regimen consisting of FTC/TDF or ABC/3TC in combination with one third ARV agent for ≥ 6 consecutive months preceding the screening visit
• •Documented plasma HIV-1 ribonucleic acid (RNA) levels \< 50 copies/mL for ≥ 6 months preceding the screening visit
• •Plasma HIV-1 RNA levels \< 50 copies/mL at screening visit
• •Estimated glomerular filtration rate (GFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
• •A female individual is eligible to enter the study if it is confirmed that she is:
• •* not pregnant
• •* of non-childbearing potential
• •* stopped menstruating for ≥ 12 months
• •* of childbearing potential and agrees to utilize the protocol-specified method of contraception or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following discontinuation of study drugs
• •Male individuals must agree to use the protocol-specified method(s) 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 the last study drug dose
• •* Male individuals must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose