HIV-1 InfectionPhase 3NCT02605954
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
A Phase 3 study testing E/C/F/TAF, ABC/3TC and Third Antiretroviral Agent in people with HIV-1 Infection, run by Gilead Sciences at 49 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- E/C/F/TAF, ABC/3TC and Third Antiretroviral Agent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 49 sitesin 6 countries
- Study dates
- 18 Nov 2015to 24 Jan 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
49 sites in 6 countries.
49 sites in 6 countries
United States12 sites
Central Texas Clinical Research
Austin, Texas, 78705
AIDS Arms, Inc./Trinity Health & Wellness Center
Dallas, Texas, 75208
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida
Tarrant County ID Associates
Fort Worth, Texas, 76104
Midway Immunology & Research Center, LLC
Ft. Pierce, Florida
Ruane Clinical Research Group
Los Angeles, California, 90036
Steinhart Medical Associates dba The Kinder Medical Group
Miami, Florida
Spectrum Medical Group
Phoenix, Arizona
The Positive Health Clinic, Allegheny Health Network
Pittsburgh, Pennsylvania
Capital Medical Associates, P.C.
Washington D.C., District of Columbia
Georgetown University
Washington D.C., District of Columbia
Triple O Research Institute PA
West Palm Beach, Florida
France11 sites
CHU - Groupe Saint-Andre
Bordeaux
Hopital Henri Mondor
Créteil
Hopital Europeen Marseille
Marseille
C.H.U. de Nantes
Nantes
C.H.U. de NICE
Nice
CHU Hotel Dieu
Paris
Hopital Lariboisiere
Paris
Hopital Necker les Enfants Malades
Paris
Hopital Saint Antoine
Paris
Hopital Saint Louis
Paris
Centre Hospitalier Gustave Dron
Tourcoing
Italy11 sites
ARNAS Garibaldi - Nesima
Catania
Unit Infectious Diseases - University of Catania - ARNAS Garibaldi
Catania
Azienda Ospedaliera Luigi Sacco
Milan
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena
Azienda Ospedale San Paolo
Monza
Azienda Ospedaliera San Gerardo
Monza
Ospedale Civile S. Spirito AUSL
Pescara
Unità Operativa Complessa di Malattie Infettive
Pescara
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
Roma
Comprensorio Ospedaliero Amedeo di Savoia
Torino
Dipartimento di Malattie Infettive e Tropicali
Torino
Spain10 sites
Hospital Clinic de Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Reg. Univ. Carlos Haya
Málaga
Hospital Costa Del Sol
Marbella
Hospital Clínico Universitario de Valencia (Galindo)
Valencia
Hospital General Universitario de Valencia (Abril)
Valencia
Hospital Alvaro Cunqueiro
Vigo
Germany4 sites
Epimed GmbH
Berlin
Universitatsklinikum Essen
Essen
ICH Study Center Hamburg
Hamburg
Universitatsklinikum Hamburg-Eppendorf
Hamburg
About this study
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
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.
- Conditions
- HIV-1 Infection
- Being tested
- E/C/F/TAF, ABC/3TC, Third Antiretroviral Agent
- Keywords
- HIV 1 Infection, HIV, Virologically-Suppressed, Antiretroviral agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E/C/F/TAFDrug
Also called Genvoya®
150/150/200/10 mg FDC tablets administered orally once daily
ABC/3TCDrug
Also called Epzicom, Kivexa
600/300 mg tablets administered orally once daily
Third Antiretroviral AgentDrug
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
| Study group | Role | What they receive |
|---|---|---|
| E/C/F/TAF | Experimental | Participants will switch to E/C/F/TAF FDC and receive treatment for 48 weeks. Receives: Drug: E/C/F/TAF |
| ABC/3TC+3rd Agent | Active comparator | 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. Receives: Drug: ABC/3TC; Drug: Third Antiretroviral Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Secondary outcomes (4)
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.
Measured: Week 12
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.
Measured: Week 48
Change From Baseline in CD4+ Cell Count at Week 24
Measured: Baseline; Week 24
Change From Baseline in CD4+ Cell Count at Week 48
Measured: Baseline; Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study start18 Nov 2015
- Primary completion14 Jun 2017
- Study completion24 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605954
- Sponsor's protocol ID
- GS-US-292-1823
- Other IDs
- 2015-002711-15, 2015
- Status last verified
- Jun 2018
- First submitted
- 13 Nov 2015
- Last updated
- 14 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02605954
- Acronym / sponsor ID
- GS-US-292-1823
- Conditions
- HIV-1 Infection
- Keywords
- HIV 1 Infection, HIV, Virologically-Suppressed, Antiretroviral agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2015 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Posted 13 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E/C/F/TAF | Experimental | Drug: E/C/F/TAFParticipants will switch to E/C/F/TAF FDC and receive treatment for 48 weeks. |
| ABC/3TC+3rd Agent | Active comparator | Drug: ABC/3TC, Drug: Third Antiretroviral AgentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E/C/F/TAFAlso: Genvoya®150/150/200/10 mg FDC tablets administered orally once daily | Drug | E/C/F/TAF |
| ABC/3TCAlso: Epzicom, Kivexa600/300 mg tablets administered orally once daily | Drug | ABC/3TC+3rd Agent |
| Third Antiretroviral AgentThird 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 | Drug | ABC/3TC+3rd Agent |
Primary outcome
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24
Time frame: 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.
4 secondary outcomes
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12
Time frame: Week 12
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 48
Time frame: Week 48
Change From Baseline in CD4+ Cell Count at Week 24
Time frame: Baseline; Week 24
Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline; Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundA 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
- Individual participant dataSharing planned: Yes. 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.
Related trials for HIV-1 Infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
49 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing E/C/F/TAF, ABC/3TC and Third Antiretroviral Agent in people with HIV-1 Infection, run by Gilead Sciences at 49 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, France, Italy, Spain, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02605954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.