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HIVPhase 3NCT01780506

Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) 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 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 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) FDC 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 12 countries
Study dates
26 Dec 2012to 6 Sep 2017
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 disoproxil fumarate (tenofovir DF)
  • Normal electrocardiogram (ECG)
  • Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
Show all 13Show 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

Who cannot join

  • A new acquired immunodeficiency syndrome (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
  • Individuals receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or individuals with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

117 sites in 12 countries.

117 sites in 12 countries

United States78 sites

  • Summa Health Care Center

    Akron, Ohio, 44304

  • Albany Medical College

    Albany, New York, 12208

  • Upstate Infectious Diseases Associates

    Albany, New York, 12208

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

    Annandale, Virginia, 22003

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • Emory University

    Atlanta, Georgia, 30308

  • Atlanta ID Group, PC

    Atlanta, Georgia, 30309

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Institute of Human Virology, University of Maryland

    Baltimore, Maryland, 21201

  • St. Hope Foundation, Inc.

    Bellaire, Texas, 77401

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Community Research Initative

    Boston, Massachusetts, 02111

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Infectious Disease Consultants, PA

    Charlotte, North Carolina, 28209

  • Northwestern University

    Chicago, Illinois, 60611

  • Ruth M. Rothstein CORE Center

    Chicago, Illinois, 60612

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • University of South Carolina School of Medicine

    Columbia, South Carolina, 29203

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

    Dallas, Texas, 75208

  • North Texas Infectious Diseases Consultants

    Dallas, Texas, 75246

  • Infectious Disease Specialist of Atlanta

    Decatur, Georgia, 30033

  • Apex Research, LLC

    Denver, Colorado, 80209

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 22710

  • New York Hospital Queens

    Flushing, New York, 11355

  • Gary Richmond, MD, PA, Inc.

    Fort Lauderdale, Florida, 33316

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Metrowest Medical Center

    Framingham, Massachusetts, 01702

  • Midway Immunology & Research Center, LLC

    Ft. Pierce, Florida, 34982

  • Garcias' Family Health Group

    Harlingen, Texas, 78550

  • ID Care

    Hillsborough, New Jersey, 08844

  • University of Hawaii - Hawaii Center for AIDS

    Honolulu, Hawaii, 96816

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Gordon E. Crofoot, MD, PA

    Houston, Texas, 77098

  • Rosedale Infectious Diseases

    Huntersville, North Carolina, 28078

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Kaiser Permanente Los Angeles

    Los Angeles, California, 90027

  • University of California, Los Angeles

    Los Angeles, California, 90035

  • Peter J. Ruane, MD, Inc.

    Los Angeles, California, 90036

  • Anthony Mills MD Inc

    Los Angeles, California, 90069

  • Mercer University School of Medicine

    Macon, Georgia, 31201

  • North Shore University Hospital - Division of Infectious Diseases

    Manhasset, New York, 11030

  • The Kinder Medical Group

    Miami, Florida, 33133

  • AIDS Healthcare Foundation

    Miami Beach, Florida, 33139

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • East Bay AIDS Center

    Oakland, California, 94609

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • IDOCF/ValuHealthMD, LLC

    Orlando, Florida, 32806

  • Infectious Diseases Associates

    Pensacola, Florida, 32504

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Kaiser Permanente - Sacramento

    Sacramento, California, 95825

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • University of California, San Diego

    San Diego, California, 92103

  • Southwest C.A.R.E. Center

    Santa Fe, New Mexico, 87505

  • Peter Shalit, MD

    Seattle, Washington, 98104

  • Baystate Infectious Diseases Clinical Research

    Springfield, Massachusetts, 01199

  • Central West Clinical Research, Inc.

    St Louis, Missouri, 63108

  • Southampton Healthcare, Inc.

    St Louis, Missouri, 63139

  • The University of South Florida

    Tampa, Florida, 33602

  • Infectious Disease Research Institute Inc.

    Tampa, Florida, 33614

  • St. Joseph's Comprenhensive Research Inisitute

    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, 90502

  • AIDS Research and Treatment Center of the Treasure Coast

    Vero Beach, Florida, 32960

  • Dupont Circle Physicians Group, P.C.

    Washington D.C., District of Columbia, 20009

  • Whitman Walker Clinic

    Washington D.C., District of Columbia, 20009

  • Capital Medical Associates, P.C.

    Washington D.C., District of Columbia, 20036

Other trials in United States

Spain9 sites

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • University Hospital Bellvitge

    Barcelona, 08907

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, 15706

Other trials in Spain

Canada8 sites

  • Clinique Medicale Du Quartier Latin

    Montreal, Quebec, H2L 5B1

  • Clinique medicale l'Actuel

    Montreal, Quebec, H2L 5B1

  • Clinique OPUS

    Montreal, Quebec, H3A 1T1

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Maple Leaf Research

    Toronto, Ontario, M5G 1K2

  • Sunnybrook Health Science Center

    Toronto, M4N 3M5

  • Spectrum Health

    Vancouver, British Columbia, V6Z 2T1

  • Health Sciences Centre Winnipeg

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Thailand6 sites

  • The HIV Netherland Australia Thailand, Thai Red Cross AIDS Research Center (The HIV-NAT)

    Bangkok, 10330

  • Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Chiang Mai University

    Chiang Mai, 50200

  • Khon Kaen University

    Khon Kaen, 40002

  • Bamrasnaradura Infectious Diseases Institute

    Nonthaburi, 11000

Other trials in Thailand

Australia5 sites

  • Melbourne Sexual Health Clinic

    Carlton, Victoria, 3053

  • Holdsworth House Medical Practice

    Darlinghurst, New South Wales, 2010

  • Taylor Square Private Clinic

    Darlington, New South Wales, 2010

  • East Sydney Doctors

    Sydney, New South Wales, 2010 NSW

  • Albion Street Centre

    Sydney, Southwest, 2010

Other trials in Australia

Switzerland3 sites

  • Universitätsspital Bern

    Bern, 3010

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

  • University Hospital, Zurich

    Zurich, CH-8091

Other trials in Switzerland

Austria2 sites

  • DIAID, Department of Dermatology, Medical University Vienna

    Vienna, 1090

  • Otto-Wagner-Spital, Sozialmedizinisches Zentrum Baumgartner Hoehe

    Vienna, 1140

Other trials in Austria

Belgium2 sites

  • Hôpital Erasme-ULB

    Anderlecht, Brussels Capital, 1070

  • CHU Saint-Pierre University Hospital

    Brussels, 1000

Other trials in Belgium

Italy1 site

  • Ospedale San Raffaele

    Milan, 20127

Other trials in Italy

Japan1 site

  • National Center for Global Health and Medicine AIDS Clinical Center

    Shinjuku-ku, Tokyo, 162-8655

Other trials in Japan

Puerto Rico1 site

  • HOPE Clinical Research

    San Juan, 00909

Other trials in Puerto Rico

United Kingdom1 site

  • Chelsea & Westminster Hospital

    London, SW10 9TH

Other trials in United Kingdom

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) FDC 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, Female, Women
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 NCT01780506
Study groupRoleWhat they receive
E/C/F/TAF (Double-Blind Phase)ExperimentalE/C/F/TAF plus E/C/F/TDF placebo for 144 weeks
Receives: Drug: E/C/F/TAF; Drug: E/C/F/TDF Placebo
E/C/F/TDF (Double-Blind Phase)Active comparatorE/C/F/TDF plus E/C/F/TAF placebo for 144 weeks
Receives: Drug: E/C/F/TDF; Drug: E/C/F/TAF Placebo
Open-Label Extension PhaseExperimentalAfter study unblinding, participants who complete 144 weeks of the study had the option to receive open-label E/C/F/TAF until commercially available, or until Gilead Sciences terminated 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 With 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 (23)

  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144

    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Weeks 96 and 144 were 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 96 and 144

  2. Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144

    The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48, 96, and 144 were 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, 96. and 144

  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. Change From Baseline in CD4+ Cell Count at Week 144

    Measured: Baseline; Week 144

  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 Hip BMD at Week 144

    Hip BMD was assessed by DXA scan.

    Measured: Baseline; Week 144

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

    Spine BMD was assessed by DXA scan.

    Measured: Baseline; Week 48

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

    Spine BMD was assessed by DXA scan.

    Measured: Baseline; Week 96

  11. Percent Change From Baseline in Spine BMD at Week 144

    Spine BMD was assessed by DXA scan.

    Measured: Baseline; Week 144

  12. Change From Baseline in Serum Creatinine at Week 48

    Measured: Baseline; Week 48

  13. Change From Baseline in Serum Creatinine at Week 96

    Measured: Baseline; Week 96

  14. Change From Baseline in Serum Creatinine at Week 144

    Measured: Baseline; Week 144

  15. Percentage of Participants Experiencing 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: Up to 48 weeks

  16. Percentage of Participants Experiencing 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: Up to 96 weeks

  17. Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144

    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: Up to 144 weeks

  18. 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

  19. 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

  20. Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144

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

    Measured: Baseline; Week 144

  21. 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

  22. 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

  23. Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144

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

    Measured: Baseline; Week 144

Timeline

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

  1. First posted31 Jan 2013 (estimated)
  2. Study start26 Dec 2012
  3. Primary completion26 Aug 2014
  4. Study completion6 Sep 2017

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
NCT01780506
Sponsor's protocol ID
GS-US-292-0104
Other IDs
2012-004458-27
Status last verified
Aug 2018
First submitted
16 Jan 2013
Last updated
19 Nov 2018
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

  • 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

  • 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 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 13 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 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Spain, Canada, Thailand, Australia 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 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 With 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 NCT01780506, which also lists 7 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 19 Nov 2018; AzTrials last refreshed its copy on 1 Nov 2026.

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