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HIV-1 InfectionPhase 3NCT02469246

Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC

A Phase 3 study testing F/TAF, ABC/3TC and 3rd ARV agent in people with HIV-1 Infection, run by Gilead Sciences at 80 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (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?
F/TAF, ABC/3TC and 3rd ARV agent
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
567 participants
Where
80 sitesin 12 countries
Study dates
29 Jun 2015to 13 Mar 2019
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

  • The ability to understand and sign a written informed consent form
  • On antiretroviral regimen containing ABC/3TC FDC in combination with one 3rd agent for ≥ 6 consecutive months prior to screening
  • Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit (measured at least twice using the same assay) and without experiencing two consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year
  • Plasma HIV-1 RNA should be < 50 copies/mL at the screening visit
  • Normal ECG
  • Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft Gault formula for creatinine clearance
Show all 11Show fewer
  • Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Serum amylase ≤ 5 × ULN
  • Females of childbearing potential and males must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug

Who cannot join

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening
  • Hepatitis B surface antigen (HBsAg) positive
  • Individuals experiencing decompensated cirrhosis
  • Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg, osteoporosis)
  • Pregnant or lactating females
  • Have an implanted defibrillator or pacemaker
Show all 13Show fewer
  • Current alcohol or substance use judged by the investigator to potentially interfere with study compliance
  • A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit
  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
  • Participation in any other clinical trial (including observational trials) without prior approval
  • Medications excluded due to the potential for interaction with emtricitabine (FTC), TAF, ABC or 3TC
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

80 sites in 12 countries.

80 sites in 12 countries

United States34 sites

  • Atlanta ID Group

    Atlanta, Georgia

  • Central Texas Clinical Research

    Austin, Texas

  • Be Well Medical Center

    Berkley, Michigan

  • Pacific Oaks Medical Group

    Beverly Hills, California

  • Howard Brown Health Center

    Chicago, Illinois

  • AIDS Arms, Inc

    Dallas, Texas

  • Gary J. Richmond,M.D.,P.A.

    Fort Lauderdale, Florida

  • Therafirst Medical Center

    Fort Lauderdale, Florida

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas

  • Midway Immunology and Research Center

    Ft. Pierce, Florida

  • Gordon E. Crofoot MD PA

    Houston, Texas

  • Therapeutic Concepts, PA

    Houston, Texas

  • The KC CARE Clinic

    Kansas City, Missouri

  • University of California San Diego (UCSD)

    La Jolla, California

  • Anthony Mills, MD, Inc.

    Los Angeles, California

  • Peter J. Ruane, MD, Inc.

    Los Angeles, California

  • University of Louisville

    Louisville, Kentucky

  • Hennepin County Medical Center

    Minneapolis, Minnesota

  • LSU Health Sciences Center

    New Orleans, Louisiana

  • Saint Michael's Medical Center

    Newark, New Jersey

  • Highland Hospital - Alameda Health System

    Oakland, California

  • Orlando Immunology Center

    Orlando, Florida

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania

  • Spectrum Medical Group

    Phoenix, Arizona

  • La Playa Medical Group and Clinical Research

    San Diego, California

  • Southwest CARE Center

    Santa Fe, New Mexico

  • Peter Shalit, MD

    Seattle, Washington

  • South Jersey Infectious Disease

    Somers Point, New Jersey

  • Southampton Healthcare, Inc.

    St Louis, Missouri

  • Montefiore Medical Center

    The Bronx, New York

  • Capial Medical Associates

    Washington D.C., District of Columbia

  • Dupont Circle Physician's Group

    Washington D.C., District of Columbia

  • Whitman-Walker Health

    Washington D.C., District of Columbia

  • Triple O Research Institute PA

    West Palm Beach, Florida

Other trials in United States

United Kingdom9 sites

  • Birmingham Heartlands Hospital

    Birmingham

  • Barts Health NHS Trust

    London

  • Chelsea and Westminster Hospital

    London

  • Imperial College

    London

  • Kings College Hospital NHS Trust

    London

  • Lewisham and Greenwich NHS Trust

    London

  • Royal Free Hospital

    London

  • St. George's Hospital

    London

  • Manchester Centre for Sexual Health

    Manchester

Other trials in United Kingdom

Germany8 sites

  • ICH Study Center Hamburg

    Bielefeld

  • Medizinische Universitatsklinik

    Bonn

  • Klinikum der Universitaet Koln

    Cologne

  • Universitatsklinikum Essen

    Essen

  • Johann Wolfgang Goethe-University Hospital

    Frankfurt

  • ifi-Studien und Projekte GmbH an der Asklepiosklinik St. Georg

    Hamburg

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg

  • Universitätsklinikum München

    Munich

Other trials in Germany

Italy6 sites

  • University of Brescia

    Brescia

  • Azienda Ospedaliera Luigi Sacco

    Milan

  • Fondazione IRCCS San Raffaele del Monte Tabor

    Milan

  • Azienda Ospedaliero Universitaria Policlinico di Modena

    Modena

  • Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

    Roma

  • Ospedale Amedeo di Savoia - Specializzato Malattie infettive

    Torino

Other trials in Italy

Spain6 sites

  • Bonaventura

    Badalona

  • Hospital Universitari de Bellvitge

    Barcelona

  • Hospital Vall d'Hebron

    Barcelona

  • Hospital Clínico Universitario San Carlos

    Madrid

  • Hospital General Universitario Gregorio Maranon

    Madrid

  • Hospital Costa Del Sol

    Málaga

Other trials in Spain

France5 sites

  • CHU - Groupe Saint-Andre

    Bordeaux

  • CHU de Bordeaux

    Bordeaux

  • C.H.U. de Nantes

    Nantes

  • CHR Orleans la Source

    Orléans

  • Chu Tours

    Tours

Other trials in France

Canada4 sites

  • Clinique medicale l'Actuel

    Montreal

  • Maple Leaf Research

    Toronto

  • Spectrum Health

    Vancouver

  • Vancouver ID Research and Care Centre Society

    Vancouver

Other trials in Canada

Belgium2 sites

  • UZ Gent

    Ghent

  • Centre Hospitalier Universitaire CHU Sart Tilman Liege

    Liège

Other trials in Belgium

Ireland2 sites

  • Mater Misericordiae University Hospital

    Dublin

  • Saint James's Hospital

    Dublin

Other trials in Ireland

Puerto Rico2 sites

  • Clinical Research Puerto Rico

    San Juan

  • Hope Clinical Research Inc

    San Juan

Other trials in Puerto Rico

Denmark1 site

  • Hvidovre Hospital

    Copenhagen

Other trials in Denmark

Sweden1 site

  • Karolinska University Hospital

    Stockholm

Other trials in Sweden

About this study

Official title: A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC.

Conditions
HIV-1 Infection
Being tested
F/TAF, ABC/3TC, ABC/3TC Placebo, F/TAF Placebo, 3rd ARV agent
Keywords
HIV, HIV-1 Positive, Virologically-Suppressed

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • F/TAFDrug

    Also called Descovy®

    200/10 mg FDC tablet (with boosted 3rd ARV agents) or 200/25 mg FDC tablet (with unboosted 3rd ARV agents) administered orally once daily

  • ABC/3TCDrug

    600/300 mg FDC tablets administered orally once daily

  • ABC/3TC PlaceboDrug

    Tablets administered orally once daily

  • F/TAF PlaceboDrug

    Tablets administered orally once daily

  • 3rd ARV agentDrug

    An allowed 3rd ARV agent of the participant's pre-existing regimen may include one of the following boosted ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; or, one of the following unboosted ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP).

Study groups in NCT02469246
Study groupRoleWhat they receive
F/TAF (Double-Blind)ExperimentalF/TAF + ABC/3TC placebo + allowed 3rd antiretroviral (ARV) agent for 96 weeks After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded.
Receives: Drug: F/TAF; Drug: ABC/3TC Placebo; Drug: 3rd ARV agent
ABC/3TC (Double-Blind)Active comparatorABC/3TC + F/TAF placebo + allowed 3rd ARV agent for 96 weeks After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded.
Receives: Drug: ABC/3TC; Drug: F/TAF Placebo; Drug: 3rd ARV agent
Open-Label F/TAFExperimentalAfter the unblinding visit, in countries where F/TAF FDC is not commercially available, participants (except in certain countries such as the UK) will be given the option to receive open-label F/TAF (200/10 mg or 200/25 mg) FDC and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country.
Receives: Drug: F/TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

    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

Secondary outcomes (11)

  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 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 96

  2. Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

    The percentage of participants with 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

  3. Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

    The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 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 96

  4. Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

    The percentage of participants achieving HIV-1 RNA < 20 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

  5. Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm

    The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 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 96

  6. Change From Baseline in CD4 Cell Count at Week 48

    Measured: Baseline; Week 48

  7. Change From Baseline in CD4 Cell Count at Week 96

    Measured: Baseline; Week 96

  8. Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

    Measured: Baseline; Week 48

  9. Percent Change From Baseline in Hip BMD at Week 96

    Measured: Baseline; Week 96

  10. Percent Change From Baseline in Spine BMD at Week 48

    Measured: Baseline; Week 48

  11. Percent Change From Baseline in Spine BMD at Week 96

    Measured: Baseline; Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2015 (estimated)
  2. Study start29 Jun 2015
  3. Primary completion11 Dec 2017
  4. Study completion13 Mar 2019

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
567 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02469246
Sponsor's protocol ID
GS-US-311-1717
Other IDs
2015-000871-28, 2015
Status last verified
Oct 2019
First submitted
9 Jun 2015
Last updated
25 Oct 2019
Data monitoring committee
Yes
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

  • Winston A, Post FA, DeJesus E, Podzamczer D, Di Perri G, Estrada V, Raffi F, Ruane P, Peyrani P, Crofoot G, Mallon PWG, Castelli F, Yan M, Cox S, Das M, Cheng A, Rhee MS. Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial. Lancet HIV. 2018 Apr;5(4):e162-e171. doi: 10.1016/S2352-3018(18)30010-9. Epub 2018 Feb 20.

    PubMed 29475804

  • Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.

    PubMed 30932951

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing F/TAF, ABC/3TC and 3rd ARV agent in people with HIV-1 Infection, run by Gilead Sciences at 80 sites in 12 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 11 inclusion and 13 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 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, United Kingdom, Germany, Italy, Spain and 7 more countries. 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 11 Jun 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 With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm (time frame: Week 48). 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 NCT02469246, which also lists 2 linked publications.

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 25 Oct 2019.

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