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, 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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV
• Intervention / Treatment: Drug: E/C/F/TAF; Drug: E/C/F/TDF Placebo; Drug: E/C/F/TDF; Drug: E/C/F/TAF Placebo

• Study Type: Interventional
• Enrollment (Actual): 872
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice
    • Darlington, New South Wales, Australia, 2010
      • Taylor Square Private Clinic
    • Sydney, New South Wales, Australia, 2010 NSW
      • East Sydney Doctors
    • Sydney, New South Wales, Australia, 2010
      • Albion Street Centre
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Melbourne Sexual Health Clinic
• Austria
  • Vienna, Austria, 1090
    • DIAID, Department of Dermatology, Medical University Vienna
  • Wien, Austria, 1140
    • Otto-Wagner-Spital, Sozialmedizinisches Zentrum Baumgartner Hoehe
• Belgium
  • Brussels, Belgium, 1000
    • CHU Saint-Pierre University Hospital
  • Brussels
    • Anderlecht, Brussels, Belgium, 1070
      • Hôpital Erasme-ULB
• Canada
  • Toronto, Canada, M4N 3M5
    • Sunnybrook Health Science Center
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2T1
      • Spectrum Health
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Centre Winnipeg
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5G 1K2
      • Maple Leaf Research
  • Quebec
    • Montreal, Quebec, Canada, H2L 5B1
      • Clinique Medicale du Quartier Latin
    • Montreal, Quebec, Canada, H2L 5B1
      • Clinique médicale l'Actuel
    • Montreal, Quebec, Canada, H3A 1T1
      • Clinique OPUS
• Italy
  • Milano, Italy, 20127
    • Ospedale San Raffaele
• Japan
  • Shinjuku-ku, Tokyo, Japan, 162-8655
    • National Center for Global Health and Medicine AIDS Clinical Center
• Puerto Rico
  • San Juan, Puerto Rico, 00909
    • Hope Clinical Research
• Spain
  • Badalona, Spain, 08916
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall D'Hebron
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial
  • Barcelona, Spain, 08907
    • University Hospital Bellvitge
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario Universitario de Santiago (CHUS)
• Switzerland
  • Berne, Switzerland, 3010
    • Universitätsspital Bern
  • Lausanne, Switzerland, 1011
    • Centre hospitalier Universitaire Vaudois
  • Zurich, Switzerland, CH-8091
    • University Hospital, Zürich
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital, Mahidol University
  • Bangkok, Thailand, 10330
    • The HIV Netherland Australia Thailand, Thai Red Cross AIDS Research Center (The HIV-NAT)
  • Chiang Mai, Thailand, 50200
    • Chiang Mai University
  • Khon Kaen, Thailand, 40002
    • Khon Kaen University
  • Nonthaburi, Thailand, 11000
    • Bamrasnaradura Infectious Diseases Institute
• United Kingdom
  • London, United Kingdom, SW10 9TH
    • Chelsea & Westminster Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Spectrum Medical Group
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles
    • Los Angeles, California, United States, 90035
      • University of California, Los Angeles
    • Los Angeles, California, United States, 90036
      • Peter J. Ruane, MD, Inc.
    • Los Angeles, California, United States, 90069
      • Anthony Mills MD Inc
    • Oakland, California, United States, 94609
      • East Bay AIDS Center
    • Sacramento, California, United States, 95825
      • Kaiser Permanente - Sacramento
    • San Diego, California, United States, 92103
      • University of California, San Diego
    • San Diego, California, United States, 92103
      • La Playa Medical Group and Clinical Research
    • Torrance, California, United States, 90502
      • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
  • Colorado
    • Denver, Colorado, United States, 80209
      • Apex Research, LLC
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20009
      • Dupont Circle Physicians Group, P.C.
    • Washington, District of Columbia, United States, 20009
      • Whitman Walker Clinic
    • Washington, District of Columbia, United States, 20036
      • Capital Medical Associates, P.C.
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Gary Richmond, MD, PA, Inc.
    • Fort Pierce, Florida, United States, 34982
      • Midway Immunology & Research Center, LLC
    • Miami, Florida, United States, 33133
      • The Kinder Medical Group
    • Miami Beach, Florida, United States, 33139
      • AIDS Healthcare Foundation
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center
    • Orlando, Florida, United States, 32806
      • IDOCF/ValuhealthMD, LLC
    • Pensacola, Florida, United States, 32504
      • Infectious Diseases Associates
    • Tampa, Florida, United States, 33602
      • The University of South Florida
    • Tampa, Florida, United States, 33614
      • Infectious Disease Research Institute Inc.
    • Tampa, Florida, United States, 33614
      • St. Joseph's Comprenhensive Research Inisitute
    • Vero Beach, Florida, United States, 32960
      • AIDS Research and Treatment Center of the Treasure Coast
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
    • Atlanta, Georgia, United States, 30308
      • AIDS Research Consortium of Atlanta
    • Atlanta, Georgia, United States, 30309
      • Atlanta ID Group, PC
    • Decatur, Georgia, United States, 30033
      • Infectious Disease Specialist of Atlanta
    • Macon, Georgia, United States, 31201
      • Mercer University School of Medicine
  • Hawaii
    • Honolulu, Hawaii, United States, 96816
      • University of Hawaii - Hawaii Center for AIDS
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60612
      • Ruth M. Rothstein CORE Center
    • Chicago, Illinois, United States, 60613
      • Howard Brown Health Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Institute of Human Virology, University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
    • Boston, Massachusetts, United States, 02111
      • Community Research Initative
    • Framingham, Massachusetts, United States, 01702
      • MetroWest Medical Center
    • Springfield, Massachusetts, United States, 01199
      • Baystate Infectious Diseases Clinical Research
  • Michigan
    • Berkley, Michigan, United States, 48072
      • Be Well Medical Center
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Central West Clinical Research, Inc.
    • Saint Louis, Missouri, United States, 63139
      • Southampton Healthcare, Inc.
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
      • ID Care
    • Newark, New Jersey, United States, 07102
      • Saint Michael's Medical Center
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Southwest C.A.R.E. Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • Albany, New York, United States, 12208
      • Upstate Infectious Diseases Associates
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center
    • Flushing, New York, United States, 11355
      • New York Hospital Queens
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital - Division of Infectious Diseases
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Infectious Disease Consultants, PA
    • Durham, North Carolina, United States, 22710
      • Duke University
    • Huntersville, North Carolina, United States, 28078
      • Rosedale Infectious Diseases
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health CARE Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Columbia, South Carolina, United States, 29203
      • University of South Carolina School of Medicine
  • Texas
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research
    • Bellaire, Texas, United States, 77401
      • St. Hope Foundation, Inc.
    • Dallas, Texas, United States, 75208
      • Trinity Health and Wellness Center/AIDS Arms, Inc.
    • Dallas, Texas, United States, 75246
      • North Texas Infectious Diseases Consultants
    • Fort Worth, Texas, United States, 76104
      • Tarrant County Infectious Disease Associates
    • Harlingen, Texas, United States, 78550
      • Garcias' Family Health Group
    • Houston, Texas, United States, 77004
      • Therapeutic Concepts, PA
    • Houston, Texas, United States, 77098
      • Gordon E. Crofoot, MD, PA
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
  • Washington
    • Seattle, Washington, United States, 98104
      • Peter Shalit, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• 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
• 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

Key Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E/C/F/TAF (Double-Blind Phase); E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks	Drug: E/C/F/TAF; 150/150/200/10 mg FDC tablet administered orally once daily; Other Names: Genvoya®; Drug: E/C/F/TDF Placebo; Tablet administered orally once daily
Active Comparator: E/C/F/TDF (Double-Blind Phase); E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks	Drug: E/C/F/TDF; 150/150/200/300 mg FDC tablet administered orally once daily; Other Names: Stribild®; Drug: E/C/F/TAF Placebo; Tablet administered orally once daily
Experimental: Open-Label Extension Phase; After 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.	Drug: E/C/F/TAF; 150/150/200/10 mg FDC tablet administered orally once daily; Other Names: Genvoya®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Weeks 96 and 144
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.	Weeks 48, 96. and 144
Change From Baseline in CD4+ Cell Count at Week 48		Baseline; Week 48
Change From Baseline in CD4+ Cell Count at Week 96		Baseline; Week 96
Change From Baseline in CD4+ Cell Count at Week 144		Baseline; Week 144
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.	Baseline; Week 48
Percent Change From Baseline in Hip BMD at Week 96	Hip BMD was assessed by DXA scan.	Baseline; Week 96
Percent Change From Baseline in Hip BMD at Week 144	Hip BMD was assessed by DXA scan.	Baseline; Week 144
Percent Change From Baseline in Spine BMD at Week 48	Spine BMD was assessed by DXA scan.	Baseline; Week 48
Percent Change From Baseline in Spine BMD at Week 96	Spine BMD was assessed by DXA scan.	Baseline; Week 96
Percent Change From Baseline in Spine BMD at Week 144	Spine BMD was assessed by DXA scan.	Baseline; Week 144
Change From Baseline in Serum Creatinine at Week 48		Baseline; Week 48
Change From Baseline in Serum Creatinine at Week 96		Baseline; Week 96
Change From Baseline in Serum Creatinine at Week 144		Baseline; Week 144
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.	Up to 48 weeks
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.	Up to 96 weeks
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.	Up to 144 weeks
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.	Baseline; Week 48
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.	Baseline; Week 96
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.	Baseline; Week 144
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.	Baseline; Week 48
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.	Baseline; Week 96
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.	Baseline; Week 144

Collaborators and Investigators

• Sponsor: Gilead Sciences

Publications and helpful links

General 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. Erratum In: Lancet. 2016 Apr 30;387(10030):1816.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2012
• Primary Completion (Actual): August 26, 2014
• Study Completion (Actual): September 6, 2017

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: January 29, 2013
• First Posted (Estimate): January 31, 2013

Study Record Updates

• Last Update Posted (Actual): November 19, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: HIV; Women; Female; Treatment Naive; HIV 1 Infected
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: GS-US-292-0104; 2012-004458-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 18 months after study completion
• IPD Sharing Access Criteria: A secured external environment with username, password, and RSA code.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No