Back to resultsSafety 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
Primary Purpose
HIV-1 Infection
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
E/C/F/TAF
ABC/3TC
Third Antiretroviral Agent
Sponsored by
About this trial
This is an interventional treatment trial for HIV-1 Infection focused on measuring HIV 1 Infection, HIV, Virologically-Suppressed, Antiretroviral agents
Eligibility Criteria
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.
Sites / Locations
- Spectrum Medical Group
- Ruane Clinical Research Group
- Capital Medical Associates, P.C.
- Georgetown University
- Gary Richmond, MD, PA, Inc.
- Midway Immunology & Research Center, LLC
- Steinhart Medical Associates dba The Kinder Medical Group
- Triple O Research Institute PA
- The Positive Health Clinic, Allegheny Health Network
- Central Texas Clinical Research
- AIDS Arms, Inc./Trinity Health & Wellness Center
- Tarrant County ID Associates
- CHU - Groupe Saint-Andre
- Hopital Henri Mondor
- Hopital Europeen Marseille
- C.H.U. de Nantes
- C.H.U. de NICE
- Hopital Saint Louis
- Hopital Saint Antoine
- CHU Hotel Dieu
- Hopital Lariboisiere
- Hopital Necker les Enfants Malades
- Centre Hospitalier Gustave Dron
- Epimed GmbH
- Universitatsklinikum Essen
- ICH Study Center Hamburg
- Universitatsklinikum Hamburg-Eppendorf
- ARNAS Garibaldi - Nesima
- Unit Infectious Diseases - University of Catania - ARNAS Garibaldi
- Azienda Ospedaliera Luigi Sacco
- Azienda Ospedaliero Universitaria Policlinico di Modena
- Azienda Ospedale San Paolo
- Azienda Ospedaliera San Gerardo
- Ospedale Civile S. Spirito AUSL
- Unità Operativa Complessa di Malattie Infettive
- Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
- Comprensorio Ospedaliero Amedeo di Savoia
- Dipartimento di Malattie Infettive e Tropicali
- Hospital Clinic de Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitari Vall d'Hebron
- Hospital General Universitario Gregorio Maranon
- Hospital Universitario 12 de Octubre
- Hospital Costa Del Sol
- Hospital Reg. Univ. Carlos Haya
- Hospital Clínico Universitario de Valencia (Galindo)
- Hospital General Universitario de Valencia (Abril)
- Hospital Alvaro Cunqueiro
- Mortimer Market Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
E/C/F/TAF
ABC/3TC+3rd Agent
Arm Description
Participants will switch to E/C/F/TAF FDC and receive treatment for 48 weeks.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at 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
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at 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
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
Change From Baseline in CD4+ Cell Count at Week 48
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02605954
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 18, 2015 (Actual)
Primary Completion Date
June 14, 2017 (Actual)
Study Completion Date
January 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection
Keywords
HIV 1 Infection, HIV, Virologically-Suppressed, Antiretroviral agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
275 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E/C/F/TAF
Arm Type
Experimental
Arm Description
Participants will switch to E/C/F/TAF FDC and receive treatment for 48 weeks.
Arm Title
ABC/3TC+3rd Agent
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
E/C/F/TAF
Other Intervention Name(s)
Genvoya®
Intervention Description
150/150/200/10 mg FDC tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
ABC/3TC
Other Intervention Name(s)
Epzicom, Kivexa
Intervention Description
600/300 mg tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Third Antiretroviral Agent
Intervention Description
Third antiretroviral agents could include one of the following:
ATV+cobicistat (COBI; Tybost®) or ATV/COBI FDC
DRV+COBI or DRV/COBI FDC
darunavir (DRV; Prezista®) + RTV
lopinavir/ritonavir (LPV/r; Kaletra®)
atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®)
efavirenz (EFV; Sustiva®)
etravirine (ETR; Intelence®)
nevirapine (NVP; Viramune®)
rilpivirine (RPV; Edurant®)
dolutegravir (DTG; Tivicay®)
raltegravir (RAL; Isentress®)
fosamprenavir (FPV; Lexiva®) + RTV
saquinavir (SQV; Invirase®) + RTV
ATV (no booster)
Drug classes:
Protease inhibitors (PI): LPV/r, ATV, RTV, ATV, DRV, FPV and SQV
Pharmacokinetic enhancer: COBI
Non-nucleoside reverse transcriptase inhibitors (NNRTI): EFV, RPV, NVP, and ETR
Integrase inhibitors: RAL and DTG
Primary Outcome Measure Information:
Title
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 48
Description
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.
Time Frame
Week 48
Title
Change From Baseline in CD4+ Cell Count at Week 24
Time Frame
Baseline; Week 24
Title
Change From Baseline in CD4+ Cell Count at Week 48
Time Frame
Baseline; Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Spectrum Medical Group
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Ruane Clinical Research Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Capital Medical Associates, P.C.
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Gary Richmond, MD, PA, Inc.
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Midway Immunology & Research Center, LLC
City
Fort Pierce
State/Province
Florida
Country
United States
Facility Name
Steinhart Medical Associates dba The Kinder Medical Group
City
Miami
State/Province
Florida
Country
United States
Facility Name
Triple O Research Institute PA
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
The Positive Health Clinic, Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
AIDS Arms, Inc./Trinity Health & Wellness Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Tarrant County ID Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
CHU - Groupe Saint-Andre
City
Bordeaux
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil
Country
France
Facility Name
Hopital Europeen Marseille
City
Marseille
Country
France
Facility Name
C.H.U. de Nantes
City
Nantes
Country
France
Facility Name
C.H.U. de NICE
City
Nice
Country
France
Facility Name
Hopital Saint Louis
City
PARIS cedex 10
Country
France
Facility Name
Hopital Saint Antoine
City
Paris cedex 12
Country
France
Facility Name
CHU Hotel Dieu
City
Paris Cedex 14
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
Country
France
Facility Name
Hopital Necker les Enfants Malades
City
Paris
Country
France
Facility Name
Centre Hospitalier Gustave Dron
City
Tourcoing
Country
France
Facility Name
Epimed GmbH
City
Berlin
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
Country
Germany
Facility Name
ICH Study Center Hamburg
City
Hamburg
Country
Germany
Facility Name
Universitatsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
ARNAS Garibaldi - Nesima
City
Catania
Country
Italy
Facility Name
Unit Infectious Diseases - University of Catania - ARNAS Garibaldi
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliera Luigi Sacco
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico di Modena
City
Modena
Country
Italy
Facility Name
Azienda Ospedale San Paolo
City
Monza
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
Country
Italy
Facility Name
Ospedale Civile S. Spirito AUSL
City
Pescara
Country
Italy
Facility Name
Unità Operativa Complessa di Malattie Infettive
City
Pescara
Country
Italy
Facility Name
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
City
Roma
Country
Italy
Facility Name
Comprensorio Ospedaliero Amedeo di Savoia
City
Torino
Country
Italy
Facility Name
Dipartimento di Malattie Infettive e Tropicali
City
Torino
Country
Italy
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Costa Del Sol
City
Marbella
Country
Spain
Facility Name
Hospital Reg. Univ. Carlos Haya
City
Málaga
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia (Galindo)
City
Valencia
Country
Spain
Facility Name
Hospital General Universitario de Valencia (Abril)
City
Valencia
Country
Spain
Facility Name
Hospital Alvaro Cunqueiro
City
Vigo
Country
Spain
Facility Name
Mortimer Market Centre
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
http://www.gilead.com/research/disclosure-and-transparency
Citations:
Citation
A Gori, G Rizzardini, C Miralles, J Olalla, JM Molina, F Raffi, P Kumar, A Antinori, M Ramgopal, HJ Stellbrink, M Das, H Chu, R Ram, W Garner, SK Chuck, D Piontkowsky, R Haubrich. Switching from An Abacavir (ABC)/Lamivudine (3TC)-Based Regimen to a Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) is Efficacious and Safe: Week 24 Primary Analysis of a Randomized Controlled Study in Virologically-Suppressed Adults [Presentation]. XVIII Congrès National de la SFLS, 19-20 October 2017, Nice Acropolis, France
Results Reference
background
Learn more about this trial
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
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