Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:November 18, 2015
End Date:January 24, 2018

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A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Abacavir/Lamivudine (ABC/3TC) Plus a Third Antiretroviral Agent to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adult Subjects

The primary objective of this study is to evaluate the efficacy of switching to
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose
combination (FDC) relative to continuing on a baseline regimen consisting of
abacavir/lamivudine (ABC/3TC) plus a 3rd antiretroviral agent in HIV-1 infected participants.


Key Inclusion Criteria:

HIV-infected adult participants who meet the following criteria will be given the option to
participate in the study:

- Currently receiving ABC/3TC plus a third antiretroviral (ARV) agent for ≥ 6
consecutive months preceding the screening visit. For subjects with 3 or more ART
regimens, a regimen history must be provided to the Sponsor for approval. Allowed
third antiretroviral agents include LPV/r, ATV+RTV, ATV+COBI (or ATV/COBI FDC),
DRV+RTV, DRV + COBI (or DRV/COBI FDC) FPV + RTV, SQV + RTV, ATV (no booster), EFV,
RPV, NVP, ETR, RAL or DTG

- Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the
screening visit (measured at least twice using the same assay). In the preceding 6
months prior to screening, one episode of "blip" (HIV-1 RNA > 50 and < 400 copies/mL)
is acceptable, only if HIV-1 RNA is < 50 copies/mL immediately before and after the
"blip".

- Plasma HIV-1 RNA < 50 copies/mL at screening visit

- Individuals will have no evidence of previous virologic failure on a PI+RTV or
integrase strand transfer inhibitor-based regimen (with or without resistance to
either class of ARV).

- All documented historical plasma genotype(s) must not show resistance to tenofovir
disoproxil fumarate (TDF) or emtricitabine (FTC), including, but not limited to the
presence of reverse transcriptase resistance mutants K65R, K70E, M184V/I, or thymidine
analog associated mutations (TAMs) (TAMs are: M41L, D67N, K70R, L210W, T215Y/F,
K219Q/E/N/R). If a historical genotype is not available or subject has 3 or more ART
regimens, subject will have proviral genotype analysis prior to Day 1 to confirm
absence of archived resistance to TDF or FTC.

- Adequate renal function defined as having an estimated glomerular filtration rate of ≥
30 mL/min as calculated by Cockcroft-Gault (eGFR-CG)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
13
sites
West Palm Beach, Florida 33401
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900 East 30th Street
Austin, Texas 78705
512-480-9660
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1 Rue Jean Burguet
Bordeaux, 33000
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Bordeaux,
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Dallas, TX
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Fort Lauderdale, Florida 33316
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Fort Pierce, Florida 34982
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Fort Pierce, FL
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1125 College Avenue
Fort Worth, Texas 76104
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Fort Worth, TX
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5901 West Olympic Boulevard
Los Angeles, California 90036
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Los Angeles, CA
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3661 South Miami Avenue
Miami, Florida 33133
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Miami, FL
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Phoenix, Arizona 85012
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Phoenix, AZ
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Pittsburgh, PA
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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Washington, District of Columbia 20036
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