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HIVPhase 3NCT01797445

Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

A Phase 3 study testing E/C/F/TAF and E/C/F/TDF in people with HIV and HIV Infections, run by Gilead Sciences at 117 sites in 11 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 efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, HIV Infections
What is being tested?
E/C/F/TAF and E/C/F/TDF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
872 participants
Where
117 sitesin 11 countries
Study dates
12 Mar 2013to 3 Oct 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

  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
  • No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP), or post-exposure prophylaxis (PEP) up to 6 months prior to screening
  • Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir DF
  • Normal electrocardiogram (ECG)
  • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
Show all 14Show 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
  • Males and females of childbearing potential 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
  • 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
  • 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
  • Age ≥ 18 years

Who cannot join

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening
  • Hepatitis B surface antigen (HBsAg) positive
  • Hepatitis C antibody positive
  • Individuals experiencing decompensated cirrhosis
  • Females who are breastfeeding
  • Positive serum pregnancy test
Show all 14Show fewer
  • Have an implanted defibrillator or pacemaker
  • Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
  • History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
  • 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
  • Receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or participants with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

117 sites in 11 countries.

117 sites in 11 countries

United States79 sites

  • Albany Medical College

    Albany, New York, 12208

  • Upstate ID Assoc

    Albany, New York, 12208

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

    Annandale, Virginia, 22003

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • Atlanta ID Group, PC

    Atlanta, Georgia, 30309

  • Emory University

    Atlanta, Georgia, 30309

  • Georgia Regents University

    Augusta, Georgia, 30912

  • University of Colorado

    Aurora, Colorado, 80045

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • St. Hope Foundation, Inc.

    Bellaire, Texas, 77401

  • Be Well Medical Center

    Berkley, Michigan, 48072-3436

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Community Research Initiative of New England

    Boston, Massachusetts, 02111

  • University of North Carolina AIDS Clinical Trials Unit

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center Myer's Park Clinic

    Charlotte, North Carolina, 28207

  • Rush University Medical Center, Section of Infectious Diseases

    Chicago, Illinois, 60305

  • The Ruth M. Rothstein CORE Center

    Chicago, Illinois, 60612

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

    Dallas, Texas, 75215

  • Southwest Infectious Disease Clinical Research, Inc.

    Dallas, Texas, 75219

  • North Texas Infectious Diseases Consultants

    Dallas, Texas, 75246

  • Infectious Disease Specialist of Atlanta

    Decatur, Georgia, 30033

  • APEX Research LLC

    Denver, Colorado, 80209

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Gary J. Richmond,M.D.,P.A.

    Fort Lauderdale, Florida, 33316

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34952

  • East Carolina University The Brody School of Medicine

    Greenville, North Carolina, 27834

  • Greenwich Hospital

    Greenwich, Connecticut, 06830

  • ID Care

    Hillsborough, New Jersey, 08844

  • University of Hawaii - Hawaii Center for AIDS

    Honolulu, Hawaii, 96821

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Gordon E. Crofoot, MD, PA

    Houston, Texas, 77098

  • Research Access Network

    Houston, Texas, 77098

  • Rosedale Infectious Disseases

    Huntersville, North Carolina, 28078

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Kaiser Permanente - Los Angeles Medical Center

    Los Angeles, California, 90027

  • University of Southern California AIDS Clinical Trials Group

    Los Angeles, California, 90033

  • Peter J. Ruane, Inc.

    Los Angeles, California, 90036

  • Anthony Mills MD Inc

    Los Angeles, California, 90069

  • Mercer University

    Macon, Georgia, 31201

  • North Shore University Hospital - Division of Infectious Diseases

    Manhasset, New York, 11030

  • AIDS Healthcare Foundation

    Miami, Florida, 33133

  • AIDS Healthcare Foundation

    Miami Beach, Florida, 33139

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Yale University

    New Haven, Connecticut, 06510

  • Chelsea Village Medical

    New York, New York, 10011

  • Columbia University Medical Center

    New York, New York, 10032

  • Weill Cornell Medical College

    New York, New York, 10065

  • Alameda County Medical Center

    Oakland, California, 94602

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Idocf/Valuhealthmd

    Orlando, Florida, 32836

  • Stanford University

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • Kaiser Permanente Medical Group

    Sacramento, California, 95825

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • Kaiser Permanente San Francisco

    San Francisco, California, 94118

  • Kaiser Permanente

    San Leandro, California, 94577

  • Southwest CARE Center

    Santa Fe, New Mexico, 87505

  • Infectious Diseases Associates of NW FL

    Sarasota, Florida, 32504

  • Peter Shalit, MD

    Seattle, Washington, 98104

  • Central West Clinical Research

    St Louis, Missouri, 63108

  • Southampton Healthcare, Inc.

    St Louis, Missouri, 63139

  • University of South Florida

    Tampa, Florida, 33602

  • Infectious Disease Research Institute Inc.

    Tampa, Florida, 33614

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida, 33614

  • 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, 90275

  • Dupont Circle Physicians Group

    Washington D.C., District of Columbia, 20009

  • Whitman-Walker Health

    Washington D.C., District of Columbia, 20009

  • Capital Medical Associates, PC

    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

  • The Research Institute

    West Springfield, Massachusetts, 01105

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

United Kingdom10 sites

  • Whittall Street Clinic

    Birmingham, B4 6DH

  • Heart Of England NHS Foundation Trust

    Birmingham, B9 5SS

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, BN2 1ES

  • Brownlee Centre, Gartnavel General Hospital

    Glasgow, G12 0YN

  • Barts Health NHS Trust

    London, E11BB

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • Kings College Hospital

    London, SE5 9RJ

  • Chelsea and Westminster

    London, SW10 9NH

  • Mortimer Market Centre

    London, WC1E 6JB

  • North Manchester General Hospital

    Manchester, M8 5RB

Other trials in United Kingdom

France9 sites

  • Hopital de la Croix Rousse

    Lyon, 69004

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

    Montpellier, 34295

  • Archet 1 CHU de Nice, Department of Infectiology

    Nice, 06200

  • Saint Louis Hospital of Infectious Diseases

    Paris, 75010

  • Hopital Saint Antoine

    Paris, 75012

  • Hôpital Bichat Claude Bernard

    Paris, 75018

  • Hopital Tenon

    Paris, 75020

  • Hopital Pitie Salpetriere

    Paris, 75651

  • CH Tourcoing

    Tourcoing, 59208

Other trials in France

Canada5 sites

  • Research Institute of McGill University Health Care

    Montreal, Quebec, H2X 2P4

  • Clinique Medicale L'actuel

    Montreal, H2L 4P9

  • University Health Network/Toronto General Hospital

    Toronto, M4N 3M5

  • Maple Leaf Research

    Toronto, M5G 1K2

  • Spectrum Health Care

    Vancouver, V6Z 2T1

Other trials in Canada

Portugal4 sites

  • Serviço de Doenças Infecciosas, HUC-CHUC, EPE

    Coimbra, 3000-075

  • Hospital Santo Antonio dos Capuchos

    Lisbon, 1169-050

  • Hospital de Santa Maria - CHLN, EPE

    Lisbon, 1649-035

  • Centro Hospitalar do Porto - Hospital Joaquim Urbano

    Porto, 4369-004

Other trials in Portugal

Italy2 sites

  • Universitaria di Bologna-Policlicnico S' Orsola Malpighi

    Bologna, 40138

  • IRCCS Ospedale San Raffaele

    Milan, 20132

Other trials in Italy

Mexico2 sites

  • Hospital Civil de Guadalajara

    Guadalajara, 44280

  • Insituto Nacional De Enfermedades Respiratorias "Ismael Cosio Villegas"

    Mexico City, 14080

Other trials in Mexico

Puerto Rico2 sites

  • Hope Clinical Research

    San Juan, 00909

  • University of Puerto Rico ACTU

    San Juan, 00935

Other trials in Puerto Rico

Sweden2 sites

  • Venhalsan / Sodersjukhuset

    Stockholm, 11883

  • Karolinska University Hospital, Huddinge

    Stockholm, 14186

Other trials in Sweden

Dominican Republic1 site

  • Instituto Dominicano de Estudios Virologicos--IDEV

    Santo Domingo, 99999

Other trials in Dominican Republic

Netherlands1 site

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC

Other trials in Netherlands

About this study

Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.

Conditions
HIV, HIV Infections
Being tested
E/C/F/TAF, E/C/F/TDF, E/C/F/TDF Placebo, E/C/F/TAF Placebo
Keywords
HIV, Treatment Naive, HIV 1 Infected, Women, Female
Medical subject headings
HIV Infections

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 tablet administered orally once daily

  • E/C/F/TDFDrug

    Also called Stribild®

    150/150/200/300 mg FDC tablet administered orally once daily

  • E/C/F/TDF PlaceboDrug

    Tablet administered orally once daily

  • E/C/F/TAF PlaceboDrug

    Tablet administered orally once daily

Study groups in NCT01797445
Study groupRoleWhat they receive
E/C/F/TAF (Double-Blind)ExperimentalE/C/F/TAF plus E/C/F/TDF placebo for 144 weeks After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded.
Receives: Drug: E/C/F/TAF; Drug: E/C/F/TDF Placebo
E/C/F/TDF (Double-Blind)Active comparatorE/C/F/TDF plus E/C/F/TAF placebo for 144 weeks After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded.
Receives: Drug: E/C/F/TDF; Drug: E/C/F/TAF Placebo
Open-Label E/C/F/TAFExperimentalAfter the unblinding visit, in countries where E/C/F/TAF is not commercially available, participants (except in UK) who complete 144 weeks of study will be given the option to receive open-label E/C/F/TAF and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country.
Receives: Drug: E/C/F/TAF

What is being measured

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

  1. Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL 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 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 (16)

  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

    The percentage of participants achieving 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

  2. Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96

    The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 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: Weeks 48 and 96

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

    Measured: Baseline; Week 48

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

    Measured: Baseline; Week 96

  5. 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

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

    Hip BMD was assessed by DXA scan.

    Measured: Baseline; Week 96

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

    Spine BMD was assessed by DXA scan.

    Measured: Baseline; Week 48

  8. Percent 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 Serum Creatinine at Week 48

    Measured: Baseline; Week 48

  10. Change From Baseline in Serum Creatinine at Week 96

    Measured: Baseline; Week 96

  11. Percentage of Participants With Treatment-emergent Proteinuria Through Week 48

    Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.

    Measured: Baseline to Week 48

  12. Percentage of Participants With Treatment-emergent Proteinuria Through Week 96

    Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.

    Measured: Baseline to Week 96

  13. Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48

    Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.

    Measured: Baseline; Week 48

  14. Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96

    Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.

    Measured: Baseline; Week 96

  15. Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48

    Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.

    Measured: Baseline; Week 48

  16. Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96

    Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.

    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 posted22 Feb 2013 (estimated)
  2. Study start12 Mar 2013
  3. Primary completion19 Sep 2014
  4. Study completion3 Oct 2018

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
872 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01797445
Sponsor's protocol ID
GS-US-292-0111
Other IDs
2013-000102-37
Status last verified
Oct 2019
First submitted
20 Feb 2013
Last updated
2 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 www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Publications

  • Sax PE, Wohl D, Yin MT, Post F, DeJesus E, Saag M, Pozniak A, Thompson M, Podzamczer D, Molina JM, Oka S, Koenig E, Trottier B, Andrade-Villanueva J, Crofoot G, Custodio JM, Plummer A, Zhong L, Cao H, Martin H, Callebaut C, Cheng AK, Fordyce MW, McCallister S; GS-US-292-0104/0111 Study Team. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015 Jun 27;385(9987):2606-15. doi: 10.1016/S0140-6736(15)60616-X. Epub 2015 Apr 15.

    PubMed 25890673

  • Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naive patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for 144 weeks. J Clin Virol. 2018 Jun;103:37-42. doi: 10.1016/j.jcv.2018.03.012. Epub 2018 Apr 2.

    PubMed 29627709

  • Arribas JR, Thompson M, Sax PE, Haas B, McDonald C, Wohl DA, DeJesus E, Clarke AE, Guo S, Wang H, Callebaut C, Plummer A, Cheng A, Das M, McCallister S. Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. J Acquir Immune Defic Syndr. 2017 Jun 1;75(2):211-218. doi: 10.1097/QAI.0000000000001350.

    PubMed 28282300

  • Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Infrequent development of drug resistance in HIV-1-infected treatment-naive subjects after 96 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate. Antivir Ther. 2017;22(5):443-446. doi: 10.3851/IMP3125. Epub 2017 Jan 11.

    PubMed 28076335

  • Margot NA, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naive patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. HIV Clin Trials. 2016 Mar;17(2):78-87. doi: 10.1080/15284336.2016.1142731.

    PubMed 26892863

  • Funderburg NT, McComsey GA, Kulkarni M, Bannerman T, Mantini J, Thornton B, Liu HC, Zhang Y, Song Q, Fang L, Dinoso J, Cheng A, McCallister S, Fordyce MW, Das M. Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide. EBioMedicine. 2016 Nov;13:321-327. doi: 10.1016/j.ebiom.2016.10.009. Epub 2016 Oct 11.

    PubMed 27742226

  • Wohl D, Oka S, Clumeck N, Clarke A, Brinson C, Stephens J, Tashima K, Arribas JR, Rashbaum B, Cheret A, Brunetta J, Mussini C, Tebas P, Sax PE, Cheng A, Zhong L, Callebaut C, Das M, Fordyce M; GS-US-2,92-01040111 and Study Team. Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results. J Acquir Immune Defic Syndr. 2016 May 1;72(1):58-64. doi: 10.1097/QAI.0000000000000940.

    PubMed 26829661

  • Custodio JM, Garner W, Callebaut C, Fordyce M, Plummer A, Zhong L, et al. The Pharmacokinetics of Tenofovir and Tenofovir Diphosphate Following Administration of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate [Oral Abstract #6]. The 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy. Washington DC, USA, May 26-28, 2015.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E/C/F/TAF and E/C/F/TDF in people with HIV and HIV Infections, run by Gilead Sciences at 117 sites in 11 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 14 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 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 117 sites in United States, United Kingdom, France, Canada, Portugal and 6 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 8 Jan 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 Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (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 NCT01797445, which also lists 8 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 Mar 2020.

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