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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01797445
Other study ID # GS-US-292-0111
Secondary ID 2013-000102-37
Status Completed
Phase Phase 3
First received
Last updated
Start date March 12, 2013
Est. completion date October 3, 2018

Study information

Verified date October 2019
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 872
Est. completion date October 3, 2018
Est. primary completion date September 19, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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

- Age = 18 years

Key Exclusion Criteria:

- 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

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily
E/C/F/TDF
150/150/200/300 mg FDC tablet administered orally once daily
E/C/F/TDF Placebo
Tablet administered orally once daily
E/C/F/TAF Placebo
Tablet administered orally once daily

Locations

Country Name City State
Canada Clinique Medicale L'actuel Montreal
Canada Research Institute of McGill University Health Care Montreal Quebec
Canada Maple Leaf Research Toronto
Canada University Health Network/Toronto General Hospital Toronto
Canada Spectrum Health Care Vancouver
Dominican Republic Instituto Dominicano de Estudios Virologicos--IDEV Santo Domingo
France Hopital de la Croix Rousse Lyon
France University Hospital of Montpellier (CHU-Gui de Chauliac) Montpellier
France Archet 1 CHU de Nice, Department of Infectiology Nice
France Hôpital Bichat Claude Bernard Paris
France Hopital Pitie Salpetriere Paris
France Hopital Saint Antoine Paris
France Hopital Tenon Paris
France Saint Louis Hospital of Infectious Diseases Paris
France CH Tourcoing Tourcoing
Italy Universitaria di Bologna-Policlicnico S' Orsola Malpighi Bologna
Italy IRCCS Ospedale San Raffaele Milan
Mexico Hospital Civil de Guadalajara Guadalajara
Mexico Insituto Nacional De Enfermedades Respiratorias "Ismael Cosio Villegas" Mexico City
Netherlands Onze Lieve Vrouwe Gasthuis Amsterdam
Portugal Serviço de Doenças Infecciosas, HUC-CHUC, EPE Coimbra
Portugal Hospital Santo Antonio dos Capuchos Lisboa
Portugal Hospital de Santa Maria - CHLN, EPE Lisbon
Portugal Centro Hospitalar do Porto - Hospital Joaquim Urbano Porto
Puerto Rico Hope Clinical Research San Juan
Puerto Rico University of Puerto Rico ACTU San Juan
Sweden Karolinska University Hospital, Huddinge Stockholm
Sweden Venhalsan / Sodersjukhuset Stockholm
United Kingdom Heart Of England NHS Foundation Trust Birmingham
United Kingdom Whittall Street Clinic Birmingham
United Kingdom Brighton and Sussex University Hospitals NHS Trust Brighton
United Kingdom Brownlee Centre, Gartnavel General Hospital Glasgow
United Kingdom Barts Health NHS Trust London
United Kingdom Chelsea and Westminster London
United Kingdom Kings College Hospital London
United Kingdom Mortimer Market Centre London
United Kingdom Royal Free London NHS Foundation Trust London
United Kingdom North Manchester General Hospital Manchester
United States Albany Medical College Albany New York
United States Upstate ID Assoc Albany New York
United States Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID) Annandale Virginia
United States AIDS Research Consortium of Atlanta Atlanta Georgia
United States Atlanta ID Group, PC Atlanta Georgia
United States Emory University Atlanta Georgia
United States Georgia Regents University Augusta Georgia
United States University of Colorado Aurora Colorado
United States Central Texas Clinical Research Austin Texas
United States St. Hope Foundation, Inc. Bellaire Texas
United States Be Well Medical Center Berkley Michigan
United States University of Alabama at Birmingham Birmingham Alabama
United States Community Research Initiative of New England Boston Massachusetts
United States Jacobi Medical Center Bronx New York
United States Montefiore Medical Center Bronx New York
United States University of North Carolina AIDS Clinical Trials Unit Chapel Hill North Carolina
United States Carolinas Medical Center Myer's Park Clinic Charlotte North Carolina
United States Rush University Medical Center, Section of Infectious Diseases Chicago Illinois
United States The Ruth M. Rothstein CORE Center Chicago Illinois
United States North Texas Infectious Diseases Consultants Dallas Texas
United States Southwest Infectious Disease Clinical Research, Inc. Dallas Texas
United States Trinity Health & Wellness Center / AIDS Arms, Inc. Dallas Texas
United States Infectious Disease Specialist of Atlanta Decatur Georgia
United States APEX Research LLC Denver Colorado
United States Henry Ford Health System Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States Gary J. Richmond,M.D.,P.A. Fort Lauderdale Florida
United States Midway Immunology and Research Center Fort Pierce Florida
United States Tarrant County Infectious Disease Associates Fort Worth Texas
United States East Carolina University The Brody School of Medicine Greenville North Carolina
United States Greenwich Hospital Greenwich Connecticut
United States ID Care Hillsborough New Jersey
United States University of Hawaii - Hawaii Center for AIDS Honolulu Hawaii
United States Gordon E. Crofoot, MD, PA Houston Texas
United States Research Access Network Houston Texas
United States Therapeutic Concepts, PA Houston Texas
United States Rosedale Infectious Disseases Huntersville North Carolina
United States DCOL Center for Clinical Research Longview Texas
United States Anthony Mills MD Inc Los Angeles California
United States Kaiser Permanente - Los Angeles Medical Center Los Angeles California
United States Peter J. Ruane, Inc. Los Angeles California
United States University of Southern California AIDS Clinical Trials Group Los Angeles California
United States Mercer University Macon Georgia
United States North Shore University Hospital - Division of Infectious Diseases Manhasset New York
United States AIDS Healthcare Foundation Miami Florida
United States AIDS Healthcare Foundation Miami Beach Florida
United States Hennepin County Medical Center Minneapolis Minnesota
United States Yale University New Haven Connecticut
United States Chelsea Village Medical New York New York
United States Columbia University Medical Center New York New York
United States Weill Cornell Medical College New York New York
United States Alameda County Medical Center Oakland California
United States Idocf/Valuhealthmd Orlando Florida
United States Orlando Immunology Center Orlando Florida
United States Stanford University Palo Alto California
United States University of Pennsylvania Philadelphia Pennsylvania
United States Spectrum Medical Group Phoenix Arizona
United States The Miriam Hospital Providence Rhode Island
United States Kaiser Permanente Medical Group Sacramento California
United States University of California, Davis Medical Center Sacramento California
United States Central West Clinical Research Saint Louis Missouri
United States Southampton Healthcare, Inc. Saint Louis Missouri
United States La Playa Medical Group and Clinical Research San Diego California
United States Kaiser Permanente San Francisco San Francisco California
United States Kaiser Permanente San Leandro California
United States Southwest CARE Center Santa Fe New Mexico
United States Infectious Diseases Associates of NW FL Sarasota Florida
United States Peter Shalit, MD Seattle Washington
United States Infectious Disease Research Institute Inc. Tampa Florida
United States St. Joseph's Comprehensive Research Institute Tampa Florida
United States University of South Florida Tampa Florida
United States Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center Torrance California
United States Capital Medical Associates, PC Washington District of Columbia
United States Dupont Circle Physicians Group Washington District of Columbia
United States Medical Faculty Associates Washington District of Columbia
United States Whitman-Walker Health Washington District of Columbia
United States Triple O Research Institute PA West Palm Beach Florida
United States The Research Institute West Springfield Massachusetts
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada,  Dominican Republic,  France,  Italy,  Mexico,  Netherlands,  Portugal,  Puerto Rico,  Sweden,  United Kingdom, 

References & Publications (8)

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 Disoprox — View Citation

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 Internati

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 A — View Citation

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 elvitegravi — View Citation

Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naïve patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for 144 weeks. J Clin Virol. 2018 Jun;103:37-42. doi: — View Citation

Margot NA, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naïve patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. HIV Clin Trials. 20 — View Citation

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, McCallist — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Week 48
Secondary 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. Week 96
Secondary 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. Weeks 48 and 96
Secondary Change From Baseline in CD4+ Cell Count at Week 48 Baseline; Week 48
Secondary Change From Baseline in CD4+ Cell Count at Week 96 Baseline; Week 96
Secondary 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
Secondary Percent Change From Baseline in Hip BMD at Week 96 Hip BMD was assessed by DXA scan. Baseline; Week 96
Secondary Percent Change From Baseline in Spine BMD at Week 48 Spine BMD was assessed by DXA scan. Baseline; Week 48
Secondary Percent Change From Baseline in Spine BMD at Week 96 Spine BMD was assessed by DXA scan. Baseline; Week 96
Secondary Change From Baseline in Serum Creatinine at Week 48 Baseline; Week 48
Secondary Change From Baseline in Serum Creatinine at Week 96 Baseline; Week 96
Secondary 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. Baseline to Week 48
Secondary 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. Baseline to Week 96
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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