AzTrials
AzTrials

HIV-1 InfectionPhase 3NCT02121795

Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

A Phase 3 study testing FTC/TDF, F/TAF and Allowed third antiretroviral agent in people with HIV-1 Infection, run by Gilead Sciences at 78 sites in 7 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

This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. 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?
FTC/TDF, F/TAF and Allowed third antiretroviral agent
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
668 participants
Where
78 sitesin 7 countries
Study dates
6 May 2014to 1 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

  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Currently receiving antiretroviral regimen containing FTC/TDF in combination with one third agent for ≥ 6 consecutive months prior to screening.
  • Plasma HIV-1 RNA levels < 50 copies/mL for at least 6 months preceding the screening visit (measured at least twice using the same assay) and not experienced 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 electrocardiogram (ECG)
  • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
Show all 14Show fewer
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × the upper limit of the normal range (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin (individuals with documented Gilbert's syndrome or with Atazanavir-associated hyperbilirubinemia may have total bilirubin up to 5 x ULN)
  • Adequate hematologic function
  • Serum amylase ≤ 5 × ULN
  • Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active, or practice abstinence from screening throughout the duration of the study treatment and for 30 days following the last dose of the study drug.
  • Females who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range.
  • Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
  • Males must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose.

Who cannot join

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening
  • Hepatitis C virus (HCV) antibody positive and HCV RNA detectable
  • Individuals experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
  • Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg, osteoporosis)
  • Females who are breastfeeding
  • Positive serum pregnancy test
Show all 12Show fewer
  • Have an implanted defibrillator or pacemaker
  • 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
  • Individuals receiving ongoing therapy with any of the medications not to be used with FTC, TAF, TDF or other antiretroviral third agents.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

78 sites in 7 countries.

78 sites in 7 countries

United States57 sites

  • Atlanta ID Group

    Atlanta, Georgia, 30309

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30312

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Community Research Initiative of New England

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Infectious Disease Consultants, PA

    Charlotte, North Carolina, 28209

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • AIDS Arms, Inc

    Dallas, Texas, 75215

  • Southwest Infectious Disease Clinical Research, Inc

    Dallas, Texas, 75219

  • North Texas Infectious Diseases Consulants

    Dallas, Texas, 75246

  • Kaiser Permanente Colorado

    Denver, Colorado, 80205

  • National Jewish Health

    Denver, Colorado, 80206

  • Apex Research LLC

    Denver, Colorado, 80209

  • New York Hospital Queens

    Flushing, New York, 11355

  • TheraFirst Medical Center

    Fort Lauderdale, Florida, 33308

  • Gary J. Richmond,M.D.,P.A.

    Fort Lauderdale, Florida, 33316

  • AIDS Arms, Inc./Trinity Health & Wellness Center

    Fort Worth, Texas, 76104

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • Kaiser Permanente

    Hayward, California, 94545

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Gordon E. Crofoot MD PA

    Houston, Texas, 77098

  • The Kc Care Clinic Site 5580

    Kansas City, Missouri, 64111

  • Tarrant County ID Associates

    Los Angeles, California, 90036

  • Southern California Men's Medical Group

    Los Angeles, California, 90069

  • Mercer University School of Medicine

    Macon, Georgia, 31201

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Tarrant County Infectious Disease Associates

    Miami, Florida, 33133

  • AIDS Healthcare Foundation

    Miami Beach, Florida, 33139

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Ricky K. Hsu, MD, PC

    New York, New York, 10011

  • Prime Healthcare Services - St Michael's LLC d/b/a Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Highland Hospital - Alameda Health System (formerly Alameda County medical Center)

    Oakland, California, 94602

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • Kaiser Permanente Sacramento Medical Center

    Sacramento, California, 95825

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • Kaiser Permanente Medical Group San Francisco

    San Francisco, California, 94118

  • Southwest CARE Center

    Santa Fe, New Mexico, 87505

  • Peter Shalit, MD

    Seattle, Washington, 98104

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • Premier Clinical Research

    Spokane, Washington, 99202

  • St. Louis University

    St Louis, Missouri, 63110

  • Southampton Healthcare, Inc.

    St Louis, Missouri, 63139

  • AIDS Healthcare Foundation

    Tampa, Florida, 33602

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • AIDS Research & Treatment Center of the Treasure Coast

    Vero Beach, Florida, 32960

  • Dupont Circle Physician's Group

    Washington D.C., District of Columbia, 20009

  • Whitman-Walker Health

    Washington D.C., District of Columbia, 20009

  • Capital Medical Associates

    Washington D.C., District of Columbia, 20036

  • Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Triple O Research Institute PA

    West Palm Beach, Florida, 33401

Other trials in United States

United Kingdom6 sites

  • Brighton and Sussex University Hospitals

    Brighton, BN2 1ES

  • Barts Health NHS Trust

    London, E1 1BB

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • King's College Hospital

    London, SE5 9RJ

  • Chelsea and Westminster Hospital

    London, SW10 9TH

  • Manchester Centre for Sexual Health

    Manchester, M13 0FH

Other trials in United Kingdom

France5 sites

  • University Hospital of Montpellier (CHU-Gui de Chauliac)

    Montpellier, 34295

  • CHU de Nantes Hopital de l'Hotel Dieu

    Nantes, 44093

  • Hopital Bichat Claude Bernard

    Paris, 75018

  • Hôpital Tenon

    Paris, 75020

  • Centre Hospitalier de Tourcoing

    Tourcoing, 59208

Other trials in France

Canada4 sites

  • Ottawa Hospital-General Campus

    Ottawa, Ontario, K1Y 4E9

  • Maple Leaf Medical Clinic/Maple Leaf Research

    Toronto, Ontario, M5B 1L6

  • University Health Network/Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Vancouver Infectious Disease Research and Care Centre

    Vancouver, British Columbia, V6Z 2C7

Other trials in Canada

Puerto Rico3 sites

  • Hope Clinical Research

    San Juan, 00901

  • Clinical Research Puerto Rico Inc

    San Juan, 00909

  • University of Puerto Rico School of Medicine

    San Juan, 00935

Other trials in Puerto Rico

Italy2 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • IRCCS Ospedale San Raffaele, Centro San Luigi

    Milan, 20127

Other trials in Italy

Belgium1 site

  • CHU Saint-Pierre of Brussels

    Brussels, 1000

Other trials in Belgium

About this study

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

This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF.

This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.

Conditions
HIV-1 Infection
Being tested
FTC/TDF, F/TAF, Allowed third antiretroviral agent, FTC/TDF Placebo, F/TAF Placebo
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.

  • FTC/TDFDrug

    Also called Truvada®

    200/300 mg FDC tablets administered orally once daily

  • F/TAFDrug

    Also called Descovy®

    Tablets administered orally once daily

  • Allowed third antiretroviral agentDrug

    An allowed third antiretroviral agent of the participant's pre-existing regimen may include one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®).

  • FTC/TDF PlaceboDrug

    Tablets administered orally once daily

  • F/TAF PlaceboDrug

    Tablets administered orally once daily

Study groups in NCT02121795
Study groupRoleWhat they receive
F/TAF + 3rd AgentExperimentalParticipants will receive F/TAF (200/25 mg or 200/10 mg) plus FTC/TDF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks. Dosing of F/TAF will be dependent on the third agent of the participants' pre-existing treatment regimen.
Receives: Drug: F/TAF; Drug: Allowed third antiretroviral agent; Drug: FTC/TDF Placebo
FTC/TDF + 3rd AgentActive comparatorParticipants will receive FTC/TDF plus F/TAF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks.
Receives: Drug: FTC/TDF; Drug: Allowed third antiretroviral agent; Drug: F/TAF Placebo

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 Defined by the FDA Snapshot Analysis

    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 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 (9)

  1. Percentage Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

    Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.

    Measured: Baseline; Week 48

  2. Percentage Change From Baseline in Spine BMD at Week 48

    Spine BMD was assessed by DXA scan.

    Measured: Baseline; Week 48

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

    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 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

  4. Change From Baseline in CD4+ Cell Count at Week 48

    Measured: Baseline; Week 48

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

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

    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 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

  7. Percentage Change From Baseline in Hip BMD at Week 96

    Hip BMD was assessed by DXA scan.

    Measured: Baseline; Week 96

  8. Percentage Change From Baseline in Spine BMD at Week 96

    Spine BMD was assessed by DXA scan.

    Measured: Baseline; Week 96

  9. Change From Baseline in CD4+ Cell Count 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 posted24 Apr 2014 (estimated)
  2. Study start6 May 2014
  3. Primary completion12 Aug 2015
  4. Study completion1 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
668 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02121795
Sponsor's protocol ID
GS-US-311-1089
Other IDs
2013-005138-39
Status last verified
Feb 2020
First submitted
22 Apr 2014
Last updated
12 Mar 2020
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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

Publications

  • Gallant JE, Daar ES, Raffi F, Brinson C, Ruane P, DeJesus E, Johnson M, Clumeck N, Osiyemi O, Ward D, Morales-Ramirez J, Yan M, Abram ME, Plummer A, Cheng AK, Rhee MS. Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, active-controlled phase 3 trial. Lancet HIV. 2016 Apr;3(4):e158-65. doi: 10.1016/S2352-3018(16)00024-2. Epub 2016 Mar 14.

    PubMed 27036991

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FTC/TDF, F/TAF and Allowed third antiretroviral agent in people with HIV-1 Infection, run by Gilead Sciences at 78 sites in 7 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 14 inclusion and 12 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 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, United Kingdom, France, Canada, Puerto Rico and 2 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 30 Nov 2016). 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 Defined by the FDA Snapshot Analysis (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 NCT02121795, 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 12 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in