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

Phase 3

Completed

Conditions: HIV-1 Infection

Interventions: Drug: E/C/F/TAF
Drug: ABC/3TC
Drug: Third Antiretroviral Agent

Registration Number: NCT02605954

Lead Sponsor: Gilead Sciences

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 275

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E/C/F/TAF	E/C/F/TAF	Participants will switch to E/C/F/TAF FDC and receive treatment for 48 weeks.
ABC/3TC+3rd Agent	Third Antiretroviral Agent	Participants will maintain prior regimen of ABC/3TC plus a third antiretroviral agent for 24 weeks followed by a delayed switch to E/C/F/TAF FDC. Note: the prior regimen is determined by the participant's clinician (prior to entry into the study) and will consist of one of the third antiretroviral agents listed.
ABC/3TC+3rd Agent	ABC/3TC	Participants will maintain prior regimen of ABC/3TC plus a third antiretroviral agent for 24 weeks followed by a delayed switch to E/C/F/TAF FDC. Note: the prior regimen is determined by the participant's clinician (prior to entry into the study) and will consist of one of the third antiretroviral agents listed.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24	Week 24	The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in CD4+ Cell Count at Week 48	Baseline; Week 48
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12	Week 12	The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 48	Week 48	The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Change From Baseline in CD4+ Cell Count at Week 24	Baseline; Week 24

Trial Locations

Locations (49): Spectrum Medical Group
🇺🇸
Phoenix, Arizona, United States
Ruane Clinical Research Group
🇺🇸
Los Angeles, California, United States
Capital Medical Associates, P.C.
🇺🇸
Washington, District of Columbia, United States
Georgetown University
🇺🇸
Washington, District of Columbia, United States
Gary Richmond, MD, PA, Inc.
🇺🇸
Fort Lauderdale, Florida, United States
Midway Immunology & Research Center, LLC
🇺🇸
Fort Pierce, Florida, United States
Steinhart Medical Associates dba The Kinder Medical Group
🇺🇸
Miami, Florida, United States
Triple O Research Institute PA
🇺🇸
West Palm Beach, Florida, United States
The Positive Health Clinic, Allegheny Health Network
🇺🇸
Pittsburgh, Pennsylvania, United States
Central Texas Clinical Research
🇺🇸
Austin, Texas, United States
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Spectrum Medical Group
🇺🇸Phoenix, Arizona, United States