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

Key Inclusion Criteria:

- Documented historical genotype report showing 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 DNA test must not have additional exclusion resistance mutations against PIs,
NRTIs and INSTIs

- Part 1 (first 50 individuals): Historical genotype report must show 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, T69 insertion and Q151M mutation
complex [A62V, V75I, F77L, F116Y, Q151M]

- Part 2 (after the interim efficacy review - 50 individuals): Historical genotype
report must show M184V and/or M184I in reverse transcriptase WITH or WITHOUT one
or two thymidine analogue-associated mutations (TAMs) [TAMs are: M41L, D67N,
K70R, L210W, T215Y/F, and K219Q/E/N/R]. Evidence of K65R, K70E, T69 insertion
and/or Q151M mutation complex [A62V, V75I, F77L, F116Y, Q151M] will not be
eligible

- Currently receiving an antiretroviral regimen consisting of FTC/TDF or ABC/3TC in
combination with one third antiretroviral agent for ≥ 6 consecutive months preceding
the screening visit

- Documented plasma HIV-1 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

Key Exclusion Criteria:

- Individuals will have no evidence of previous virologic failure on a PI/r or
INSTI-based regimen (with or without resistance to either class of ARV). Individuals
may have evidence of prior virologic failure on only an NNRTI plus 2 NRTI-based
regimen

- Individuals on a current PI/r-based regimen will have no evidence of previous use of
any approved or experimental integrase strand transfer inhibitor (INSTI) (for any
length of time)

- Hepatitis C infection that would require therapy during the study

- Hepatitis B surface antigen (HBsAg) positive

- Individuals with clinical evidence of decompensated cirrhosis (e.g., ascites,
encephalopathy, variceal bleeding, etc.)

- Have an implanted defibrillator or pacemaker

- 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. Individuals with cutaneous KS are
eligible, but must not have received any systemic therapy for KS within 30 days of Day
1 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 Day 1

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.