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AzTrials

HIV-1 InfectionPhase 3NCT02345226

Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults

A Phase 3 study testing FTC/RPV/TAF and EFV/FTC/TDF in people with HIV-1 Infection, run by Gilead Sciences at 117 sites in 9 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 objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate… 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/RPV/TAF and EFV/FTC/TDF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
881 participants
Where
117 sitesin 9 countries
Study dates
26 Jan 2015to 2 Jan 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, which must be obtained prior to initiation of study procedures
  • Currently receiving EFV/FTC/TDF FDC for ≥ 6 consecutive months preceding the screening visit
  • Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 6 months preceding the screening visit. Unconfirmed virologic elevation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or "blip") and prior to screening is acceptable
  • Have no documented resistance to any of the study agents at any time in the past
  • HIV-1 RNA < 50 copies/mL at the screening visit
  • Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
Show all 11Show fewer
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)
  • Serum amylase ≤ 5 × ULN (individuals with serum amylase > 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN)
  • Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
  • Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min according to the Cockcroft-Gault formula

Who cannot join

  • Hepatitis B surface antigen (HBsAg) positive
  • Hepatitis C antibody positive with detectable hepatitis C virus (HCV) RNA (individuals who have HCV antibody but no detectable HCV RNA are eligible to enroll)
  • Individuals experiencing or with a medical history of decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
  • Females who are breastfeeding
  • Positive serum pregnancy test
  • Current alcohol or substance use judged by the Investigator to potentially interfere with the individual's study compliance
Show all 12Show fewer
  • 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. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline/Day 1 and must not be anticipated to require systemic therapy during the study
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline/Day 1
  • 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 from the sponsor is prohibited while participating in this trial
  • Individuals receiving ongoing therapy with any of the disallowed medications listed in the protocol, including drugs not to be used with FTC, RPV and/or TAF; or individuals with any known allergies to the excipients of FTC/RPV/TAF
  • Note: Other protocol defined inclusion/exclusion criteria may apply.

Trial locations and contacts

117 sites in 9 countries.

117 sites in 9 countries

United States79 sites

  • Upstate Infectious Diseases Associates

    Albany, New York

  • Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)

    Annandale, Virginia

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia

  • Atlanta ID Group

    Atlanta, Georgia

  • University of Colorado

    Aurora, Colorado

  • Central Texas Clinical Research

    Austin, Texas

  • Be Well Medical Center

    Berkley, Michigan

  • AHF Research Center

    Beverly Hills, California

  • Pacific Oaks Medical Group

    Beverly Hills, California

  • Boston University Medical Center

    Boston, Massachusetts

  • Brigham and Women's

    Boston, Massachusetts

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina

  • Medical University of South Carolina

    Charleston, South Carolina

  • Infectious Disease Consultants, PA

    Charlotte, North Carolina

  • The CORE Foundation

    Chicago, Illinois

  • The Ohio State University

    Columbus, Ohio

  • North Texas Infectious Diseases Consultants

    Dallas, Texas

  • Southwest Infectious Disease Clinical Research, Inc.

    Dallas, Texas

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

    Dallas, Texas

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia

  • Apex Research Institute

    Denver, Colorado

  • Henry Ford Health System

    Detroit, Michigan

  • Gary Richmond, MD, PA, Inc.

    Fort Lauderdale, Florida

  • Therafirst Medical Centers

    Fort Lauderdale, Florida

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

    Fort Worth, Texas

  • MetroWest Medical Center

    Framingham, Massachusetts

  • Midway Immunology & Research Center, LLC

    Ft. Pierce, Florida

  • The Brody School of Medicine

    Greenville, North Carolina

  • Gordon E. Crofoot, MD, PA

    Houston, Texas

  • Research Access Network

    Houston, Texas

  • Rosedale Infectious Diseases

    Huntersville, North Carolina

  • Indiana University Medical Center

    Indianapolis, Indiana

  • Long Beach Education and Research Consultants

    Long Beach, California

  • DCOL Center for Clinical Research

    Longview, Texas

  • Kaiser Permanente

    Los Angeles, California

  • Southern California Men's Medical Group

    Los Angeles, California

  • Tarrant County ID Associates

    Los Angeles, California

  • Mercer University School of Medicine

    Macon, Georgia

  • North Shore University Hospital

    Manhasset, New York

  • AIDS Healthcare Foundation

    Miami, Florida

  • University of Miami

    Miami, Florida

  • AIDS Healthcare Foundation

    Miami Beach, Florida

  • Hennepin County Medical Center

    Minneapolis, Minnesota

  • Yale University School of Medicine

    New Haven, Connecticut

  • Columbia University Medical Center/ New York Presbyterian

    New York, New York

  • Saint Michael's Medical Center

    Newark, New Jersey

  • World Health Clinicians' CIRCLE CARE Center

    Norwalk, Connecticut

  • Orlando Immunology Center

    Orlando, Florida

  • Infectious Diseases Associates of NW Florida, P.A.

    Pensacola, Florida

  • University of Pennsylvania

    Philadelphia, Pennsylvania

  • Maricopa Integrated Health System

    Phoenix, Arizona, 85004

  • Spectrum Medical Group

    Phoenix, Arizona

  • The Miriam Hospital

    Providence, Rhode Island

  • Kaiser Permanente

    Sacramento, California

  • University of California-UC Davis

    Sacramento, California

  • La Playa Medical Group and Clinical Research

    San Diego, California

  • Kaiser Permanente

    San Francisco, California

  • Optimus Medical

    San Francisco, California

  • Kaiser Permanente

    San Leandro, California

  • Southwest CARE Center

    Santa Fe, New Mexico

  • Chatham County Health Department

    Savannah, Georgia

  • Peter Shalit, MD

    Seattle, Washington

  • South Jersey Infectious Disease

    Somers Point, New Jersey

  • Premier Clinical Research

    Spokane, Washington

  • Baystate Infectious Diseases Clinical Research

    Springfield, Massachusetts

  • The Research Institute

    Springfield, Massachusetts

  • Southampton Healthcare, Inc.

    St Louis, Missouri

  • Hillsborough County Health Dept.

    Tampa, Florida

  • Infectious Disease Research Institute Inc.

    Tampa, Florida

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida

  • Jacobi Medical Center

    The Bronx, New York

  • Montefiore Medical Center

    The Bronx, New York

  • Los Angeles BioMedical Institute at Harbor-UCLA Medical Center

    Torrance, California

  • AIDS Research & Treatment Center of the Treasure Coast

    Vero Beach, Florida

  • Capital Medical Associates, P.C.

    Washington D.C., District of Columbia

  • Medical Faculty Associates, Inc.

    Washington D.C., District of Columbia

  • Whitman Walker Clinic

    Washington D.C., District of Columbia

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida

  • Rowan Tree Medical PA

    Wilton Manors, Florida

Other trials in United States

Germany9 sites

  • Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH (zibp)

    Berlin

  • University of Bonn

    Bonn

  • Universitat zu Koln

    Cologne

  • Center for HIV and Hepatogastroenterology

    Düsseldorf

  • Universitätsklinikum Essen

    Essen

  • Infektiologikum

    Frankfurt

  • ICH Study Center Hamburg

    Hamburg

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg

  • MUC Research GmbH

    München

Other trials in Germany

Canada8 sites

  • University of Alberta

    Edmonton, Alberta

  • Clinique medicale l'Actuel

    Montreal, Quebec

  • Clinique OPUS

    Montreal, Quebec

  • McGill University Health Centre

    Montreal, Quebec

  • Maple Leaf Research

    Toronto, Ontario

  • University Health Network

    Toronto, Ontario

  • Spectrum Health

    Vancouver, British Columbia

  • Health Sciences Centre

    Winnipeg, Manitoba

Other trials in Canada

Spain6 sites

  • Hospital General Universitario de Alicante

    Alicante

  • Hospital Clinic i Provincial

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Universitary de Bellvitge

    Barcelona

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario La Paz

    Madrid

Other trials in Spain

United Kingdom4 sites

  • Barts & The London NHS Trust

    London

  • King's College Hospital

    London

  • Mortimer Market Centre

    London

  • The Royal Free Hampstead NHS Trust

    London

Other trials in United Kingdom

France3 sites

  • Hopital Bichat Claude Bernard

    Paris

  • Hopital Saint Louis

    Paris

  • Chu Tours

    Tours

Other trials in France

Puerto Rico3 sites

  • Clinical Research Puerto Rico Inc

    San Juan

  • Hope Clinical Research

    San Juan

  • University of Puerto Rico School of Medicine

    San Juan

Other trials in Puerto Rico

Switzerland3 sites

  • University Hospital Basel

    Basel

  • Geneva University Hospital

    Geneva

  • Centre Hospitalier Universitaire Vaudois

    Lausanne

Other trials in Switzerland

Belgium2 sites

  • CHU Saint-Pierre University Hospital

    Brussels

  • Cliniques Universitaires UCL Saint-Luc

    Brussels

Other trials in Belgium

About this study

Official title: A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects

The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants.

Conditions
HIV-1 Infection
Being tested
FTC/RPV/TAF, EFV/FTC/TDF Placebo, EFV/FTC/TDF, FTC/RPV/TAF Placebo
Keywords
HIV

What participants receive

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

  • FTC/RPV/TAFDrug

    Also called Odefsey®

    200/25/25 mg FDC tablets administered orally once daily

  • EFV/FTC/TDF PlaceboDrug

    Tablets administered orally once daily

  • EFV/FTC/TDFDrug

    Also called Atripla®

    600/200/300 mg FDC tablets administered orally once daily

  • FTC/RPV/TAF PlaceboDrug

    Tablets administered orally once daily

Study groups in NCT02345226
Study groupRoleWhat they receive
FTC/RPV/TAFExperimentalFTC/RPV/TAF plus EFV/FTC/TDF placebo for at least 96 weeks.
Receives: Drug: FTC/RPV/TAF; Drug: EFV/FTC/TDF Placebo
EFV/FTC/TDFActive comparatorEFV/FTC/TDF plus FTC/RPV/TAF placebo for at least 96 weeks.
Receives: Drug: EFV/FTC/TDF; Drug: FTC/RPV/TAF Placebo
Open Label Extension PhaseExperimentalAfter the Week 96 visit, participants will be given the option to receive open label FTC/RPV/TAF for up to an additional 48 weeks. In countries where FTC/RPV/TAF is not yet commercially available, participants will be given the option to receive open-label FTC/RPV/TAF and attend visits every 12 weeks until FTC/RPV/TAF becomes commercially available, or until Gilead elects to discontinue the study, whichever occurs first.
Receives: Drug: FTC/RPV/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 Defined by the US 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 patient'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 48 as Defined by the US 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 patient'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

  2. Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US 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 patient'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

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

    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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. Change From Baseline in CD4+ Cell Count at Week 48

    Measured: Baseline; Week 48

  5. Change From Baseline in CD4+ Cell Count at Week 96

    Measured: Baseline; Week 96

  6. Percent 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

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

    Hip BMD was assessed by DXA scan.

    Measured: Baseline; Week 96

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

    Spine BMD was assessed by DXA scan.

    Measured: Baseline; Week 48

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

    Spine BMD was assessed by DXA scan.

    Measured: Baseline; Week 96

  10. Change From Baseline in HIV Symptoms Index Score (HIVSI) at Week 48

    The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing.

    Measured: Baseline; Week 48

  11. Change From Baseline in HIVSI Score at Week 96

    The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing.

    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 posted26 Jan 2015 (estimated)
  2. Study start26 Jan 2015
  3. Primary completion29 Jun 2016
  4. Study completion2 Jan 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
881 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02345226
Sponsor's protocol ID
GS-US-366-1160
Other IDs
2014-004779-21, 2014
Status last verified
Dec 2019
First submitted
19 Jan 2015
Last updated
2 Jan 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 http://www.gilead.com/research/disclosure-and transparency

Publications

  • Hagins D, Orkin C, Daar ES, Mills A, Brinson C, DeJesus E, Post FA, Morales-Ramirez J, Thompson M, Osiyemi O, Rashbaum B, Stellbrink HJ, Martorell C, Liu H, Liu YP, Porter D, Collins SE, SenGupta D, Das M. Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials. HIV Med. 2018 Nov;19(10):724-733. doi: 10.1111/hiv.12664. Epub 2018 Aug 12.

    PubMed 30101539

  • Mills A, Brinson C, Martorell C, Crofoot G, Daar E, Osiyemi O, et al. Switching to RPV/FTC/TAF from RPV/FTC/TDF or EFV/FTC/TDF: Week 96 Results. Conference on Retroviruses and Opportunistic Infections, Boston. March 4-7, 2018, Abstract 504.

  • Arribas JR, Rockstroh J, Post, Yazdanpanah Y, Cavassini, DeJesus E, et al. Bone and renal safety of switching to rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF) from single-tablet regimens (STRs) containing efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) or rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF): Week 48 subgroup analysis in patients at risk of or with comorbidities. Abstract accepted for presentation at the 16th European AIDS Conference, 2017 25-27 October Milan, Italy.

  • Porter DP, KulkarniR, Cao H, SenGupta D, and White KL. No Emergent Resistance in HIV-1 Virologically-Suppressed Subjects Who Switched to RPV/FTC/TAF [Poster 1381]. ID Week 2017 4-8 October; San Diego, California.

  • E DeJesus, M Ramgopal, G Crofoot, P Ruane, A LaMarca. J-M Molina et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Older Adults. 8th International Workshop on HIV and Aging 2017 2-3 October, New York, New York.

  • Molina JM, DeJesus E, Rijnders B, Post FAV, B., Stoeckle M, ThalmeA, et al. Efficacy and Safety of Switching From RPV/FTC/TDF or EFV/FTC/TDF to RPV/FTC/TAF in Black Adults [Presentation MOPEB0291]. 9th IAS Conference on HIV Science 2017 23-26 July Paris, France.

  • Rockstroh J, Orkin C, Yazdanpanah Y, Di Perri GDS, P. E., Arribas JR, Brinkman K, et al. Switching From TDF to TAF Improves Bone and Renal Safety Independent of Age, Sex, Race, or 3rd Agent: Results From Pooled Analysis (N=3816) of Virologically Suppressed HIV-1 Infected Adults [Presentation MOPEB0289]. 9th IAS Conference on HIV Science; 2017 23 26 July Paris, France.

  • DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Martorell CT, de Wet J, Stellbrink HJ, Molina JM, Post FA, Valero IP, Porter D, Liu Y, Cheng A, Quirk E, SenGupta D, Cao H. Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e205-e213. doi: 10.1016/S2352-3018(17)30032-2. Epub 2017 Mar 2.

    PubMed 28259776

  • Majeed SR, Shao Y, Garner W, Scott J, Pérez-Ruixo C, SenGupta D, et al. Evaluation of RPV/FTC/TAF Exposure-Efficacy and Exposure-Safety Relationships [Poster 427]. Conference on Retroviruses and Opportunistic Infections (CROI) 2017 13-16 February; Seattle, Washington.

  • Hagins D, Mills A, Martorell C, Walmsley S, Gallant J, Tebas P, et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Women [Abstract 12]. 7th International Workshop on HIV & Women; 2017 11-12 February; Seattle, Washington.

  • Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, et al. 48 Week Results from two studies: Switching to RPV/FTC/TAF from EFV/FTC/TDF (Study 1160) or RPV/FTC/TDF (Study 1216) [Presentation]. HIV Glasgow; 2016 23-26 October; Glasgow, United Kingdom.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FTC/RPV/TAF and EFV/FTC/TDF in people with HIV-1 Infection, run by Gilead Sciences at 117 sites in 9 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 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Germany, Canada, Spain, United Kingdom and 4 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 19 Oct 2017). 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 US 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 NCT02345226, which also lists 11 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 2 Jan 2020.

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