A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects who are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

As treatment guidelines recommend early treatment of HIV-1 infection, there is
need for new regimens offering enhanced product safety and tolerability,
effectiveness, and convenience for long-term treatment.

While TDF is an effective drug used broadly in the treatment of HIV-1 infection
as a part of multiple combination regimens, including Complera/Eviplera,
patients may benefit from anticipated improvements in the safety profile with
the replacement of TDF with TAF. The
development of FTC/RPV/TAF is expected to provide an additional option for
HIV-1 infected patients: a TAF-containing, NNRTI-based FDC that can be
administered as one tablet, once daily, with improved renal and bone safety.

This study will evaluate the safety, efficacy and tolerability of switching
from Complera/Eviplera to FTC/RPV/TAF, thereby assessing the viability of
FTC/RPV/TAF as a FDC option for HIV-infected patients.

Main objective:
To evaluate the non-inferiority of switching to the FTC/RPV/TAF FDC as compared
to continuing FTC/RPV/TDF FDC in virologically suppressed HIV-1 infected
subjects as determined by maintaining HIV-1 RNA < 50 copies/mL at Week 48 (FDA
Snapshot Algorithm).

Secondary objective:
To determine the safety of the two treatment arms as determined by the percent
change from baseline in hip and spine bone mineral density as
assessed by dual energy X-ray absorptiometry (DXA) at Week 48 in a subset of
subjects.
To evaluate the safety and tolerability of the two treatment arms through Week
48.

Randomized, double-blind, multicenter study to evaluate the safety and efficacy
of FTC/RPV/TAF FDC versus continuing FTC/RPV/TDF FDC in HIV-1 infected subjects
who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable regimen
of
FTC/RPV/TDF FDC for >= 6 consecutive months prior to screening.

Subjects will be randomized in a 1:1 ratio to one of the following two
treatment arms:

Treatment Arm 1: FDC of emtricitabine 200 mg/rilpivirine 25 mg tenofovir
alafenamide 25 mg (FTC/RPV/TAF) QD + Placebo to match FDC of emtricitabine 200
mg/rilpivirine 25 mg /tenofovir disoproxil fumarate 300 mg (FTC/RPV/TDF) QD (n
= 275)

Treatment Arm 2: FDC emtricitabine 200 mg/rilpivirine 25 mg/ tenofovir
disoproxil fumarate 300 mg (FTC/RPV/TDF) QD + Placebo to match FDC of
emtricitabine 200 mg/rilpivirine 25 mg/ tenofovir alafenamide 25 mg
(FTC/RPV/TAF) QD (n = 275)
Subjects will be treated for at least 48 weeks. After the last subject
completes the Week 48 visit and Gilead completes the Week 48 analysis, all
subjects will attend the Unblinding Visit, at which point subjects will be
given the option to receive FTC/RPV/TAF FDC in an open label extension phase
for 48 weeks (except in UK) or until Gilead Sciences elects to terminate the
study, whichever occurs first. Subjects who complete the study through Week 48
and do not wish to continue to participate in the open label extension will be
required to
return to the clinic 30 days after the completion of the study drug for a
30-Day Follow-up Visit. After the Unblinding Visit, subjects in the UK will
stop taking their study drug and complete a 30 day follow up visit.

Test Product, Dose, and Mode of Administration:
Emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg
(FTC/RPV/TAF) FDC administered orally QD with food

Reference Therapy, Dose, and Mode of Administration:
Emtricitabine 200 mg/rilpivirine 25 mg /tenofovir disoproxil fumarate 300 mg
(FTC/RPV/TDF) FDC administered orally QD with food

For a complete overview of study procedures please refer to the protocol and
patient information leaflet. All risks are described in there.

Laboratory analyses (hematology, chemistry, and urinalysis), HIV-1 RNA, CD4+
cell count, and complete or symptom directed physical examinations will be
performed at the Screening, Baseline/Day 1, and all subsequent study visits.
Subjects will be treated for 48 weeks.

Subjects will return for study visits at Weeks 4, 8, 12, 24, 36 and 48.

Blood and urine for selected bone and renal safety evaluations will be
collected at Baseline/Day 1, Weeks 24, 48, Unblinding and ESDD (if applicable).

Blood for pharmacokinetic analysis will be collected at Weeks 4, 8, 12 and 24.

A subset of subjects (approximately 300) who provide a separate informed
consent, will participate in a DXA substudy. DXA scans will be performed prior
to study drug administration at Baseline/Day 1, and then every 24 weeks
throughout the study and at the

Early Study Drug Discontinuation Visit, if > 12 weeks since last scan. Scans
will cover the spine and hip to measure changes in bone mineral density.

Subjects will be treated for at least 48 weeks. After the last subject
completes the Week 48 visit and Gilead completes the Week 48 analysis, all
subjects will attend the Unblinding Visit, at which point subjects will be
given the option to receive FTC/RPV/TAF FDC in an open label extension phase
for 48 weeks (except in UK) or until Gilead Sciences elects to terminate the
study, whichever occurs first.

Subjects who complete the study through Week 48 and do not wish to continue to
participate in the open label extension will be required to return to the
clinic 30 days after the completion of the study drug for a 30-Day Follow-up
Visit.

After the Unblinding Visit, subjects in the UK will stop taking their
study drug and complete a 30 day follow up visit.