CompletedNCT01108510Updated May 23, 2016Results posted

Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

A Phase 3 interventional study of COBI and RTV in HIV and HIV Infections, sponsored by Gilead Sciences. Completed at 134 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-23.

Sponsored by Gilead Sciences · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 698
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening.

Conditions studied

HIV
HIV Infections

Browse trials for

HIV Infections 4,258

Keywords

Treatment Naive
HIV 1 Infected

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 698 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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 ≥ 5,000 copies/mL at screening
No prior use of any approved or investigational antiretroviral drug for any length of time
Screening genotype report must show sensitivity to FTC, TDF and ATV
Normal ECG
Adequate renal function (eGFR calculated using the Cockcroft-Gault equation ≥ 70 mL/min)
Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Serum amylase ≤ 5 x ULN
Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug.
Age ≥ 18 years
Life expectancy ≥ 1 year

Exclusion criteria

Exclusion Criteria:

A new AIDS-defining condition diagnosed within the 30 days prior to screening
Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for Hepatitis C
Subjects experiencing decompensated cirrhosis
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Have an implanted defibrillator or pacemaker
Have an ECG PR interval ≥ 220 msec
Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline.
Medications contraindicated for use with COBI, emtricitabine (FTC), tenofovir disoproxil fumarate (TDF), atazanavir (ATV), ritonavir (RTV) or subjects with any known allergies to the excipients of COBI tablets, Truvada tablets, atazanavir capsules or ritonavir tablets.
Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial.
Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 698 participants (actual)

Study arms

Experimental
ATV+COBI+FTC/TDF
COBI + RTV placebo + ATV + FTC/TDF once daily
Drug: COBI · Drug: ATV · Drug: FTC/TDF · Drug: RTV placebo
Active comparator
ATV+RTV+FTC/TDF
RTV + COBI placebo + ATV + FTC/TDF once daily
Drug: RTV · Drug: ATV · Drug: FTC/TDF · Drug: COBI placebo

Interventions

DrugCOBI
Cobicistat (COBI) 150 mg tablet administered orally once daily
Also known as: Tybost®, GS-9350
DrugRTV
Ritonavir (RTV) 100 mg tablet administered orally once daily
Also known as: Norvir®
DrugATV
Atazanavir (ATV) 300 mg capsule administered orally once daily
Also known as: Reyataz®
DrugFTC/TDF
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
Also known as: Truvada®
DrugCOBI placebo
Placebo to match COBI administered orally once daily
DrugRTV placebo
Placebo to match RTV administered orally once daily

What researchers measure

Primary outcomes

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 48

Secondary outcomes

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.
Time frame: Week 96
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.
Time frame: Week 144
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.
Time frame: Week 192
Change From Baseline in CD4 Cell Count at Week 48
Time frame: Baseline to Week 48
Change From Baseline in CD4 Cell Count at Week 96
Time frame: Baseline to Week 96
Change From Baseline in CD4 Cell Count at Week 144
Time frame: Baseline to Week 144
Change From Baseline in CD4 Cell Count at Week 192
Time frame: Baseline to Week 192

Results

Posted Oct 28, 2014

Limitations and caveats

There were no limitations affecting the analysis or results.

Participant flow

Participants were enrolled in a total of 144 study sites in Asia, Australia, Europe, and South and North America. The last study visit occurred on 17 April 2015.

Participant flow — Overall Study
Milestone	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF
Started	349	349
Completed	70	81
Not completed	279	268
Withdrew: Randomized but not treated	5	1
Withdrew: Joined another gilead-sponsored study	186	195
Withdrew: Adverse event	26	19
Withdrew: Lost to follow-up	20	17
Withdrew: Withdrew consent	21	15
Withdrew: Investigator's discretion	12	10
Withdrew: Participant noncompliance	5	7
Withdrew: Lack of efficacy	3	0
Withdrew: Pregnancy	0	3
Withdrew: Death	1	1

Outcome measures

PrimaryPercentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.

Time frame:: Week 48
Reported as:: Number · percentage of participants

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
percentage of participants	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48	85.2	87.4

Statistical analysis

ATV+COBI+FTC/TDF vs ATV+RTV+FTC/TDF · Difference in percentages: -2.2 · 95.2% CI -7.4 to 3.0Difference in percentages of success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.

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

The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.

Time frame:: Week 96
Reported as:: Number · percentage of participants

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
percentage of participants	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96	77.9	79.3

Statistical analysis

ATV+COBI+FTC/TDF vs ATV+RTV+FTC/TDF · Difference in percentages: -1.4 · 95% CI -7.6 to 4.7Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.

SecondaryPercentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144

The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.

Time frame:: Week 144
Reported as:: Number · percentage of participants

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
percentage of participants	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144	72.1	74.1

Statistical analysis

ATV+COBI+FTC/TDF vs ATV+RTV+FTC/TDF · Difference in percentages: -2.1 · 95% CI -8.7 to 4.5Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.

SecondaryPercentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192

The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.

Time frame:: Week 192
Reported as:: Number · percentage of participants

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
percentage of participants	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192	71.6	79.7

Statistical analysis

ATV+COBI+FTC/TDF vs ATV+RTV+FTC/TDF · Difference in percentages: -8.0 · 95% CI -22.2 to 6.3Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.

SecondaryChange From Baseline in CD4 Cell Count at Week 48

Time frame:: Baseline to Week 48
Reported as:: Mean · cells/μL

Change From Baseline in CD4 Cell Count at Week 48
cells/μL	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF
Change From Baseline in CD4 Cell Count at Week 48	213 ± 151.0	219 ± 150.4

Statistical analysis

ATV+COBI+FTC/TDF vs ATV+RTV+FTC/TDF · ANOVA · p = 0.67 (P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.) · Difference in least squares mean (lsm): -5 · 95% CI -28 to 18The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.

SecondaryChange From Baseline in CD4 Cell Count at Week 96

Time frame:: Baseline to Week 96
Reported as:: Mean · cells/μL

Change From Baseline in CD4 Cell Count at Week 96
cells/μL	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF
Change From Baseline in CD4 Cell Count at Week 96	277 ± 176.8	287 ± 181.5

Statistical analysis

ATV+COBI+FTC/TDF vs ATV+RTV+FTC/TDF · ANOVA · p = 0.51 (P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.) · Difference in lsm: -10 · 95% CI -38 to 19The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.

SecondaryChange From Baseline in CD4 Cell Count at Week 144

Time frame:: Baseline to Week 144
Reported as:: Mean · cells/μL

Change From Baseline in CD4 Cell Count at Week 144
cells/μL	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF
Change From Baseline in CD4 Cell Count at Week 144	310 ± 188.0	332 ± 199.8

Statistical analysis

ATV+COBI+FTC/TDF vs ATV+RTV+FTC/TDF · ANOVA · p = 0.18 (P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.) · Difference in lsm: -22 · 95% CI -54 to 10The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.

SecondaryChange From Baseline in CD4 Cell Count at Week 192

Time frame:: Baseline to Week 192
Reported as:: Mean · cells/μL

Change From Baseline in CD4 Cell Count at Week 192
cells/μL	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF
Change From Baseline in CD4 Cell Count at Week 192	350 ± 191.3	343 ± 190.7

Statistical analysis

ATV+COBI+FTC/TDF vs ATV+RTV+FTC/TDF · ANOVA · p = 0.84 (P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.) · Difference in lsm: 6 · 95% CI -55 to 67The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.

Adverse events

Collected over Baseline through end of study drug treatment (average exposure: ATV+COBI+FTC/TDF group = 141.3 weeks; ATV+RTV+FTC/TDF group = 143.0 weeks) plus 30 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ATV+COBI+FTC/TDF	—	64/344 (18.6%)	311/344 (90.4%)
ATV+RTV+FTC/TDF	—	50/348 (14.4%)	312/348 (89.7%)

Most frequent serious events

Showing 10 of 152

Most frequent serious events
Event	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF
Subcutaneous abscessInfections and infestations	4/344	0/348
Renal failure acuteRenal and urinary disorders	1/344	4/348
Chest painGeneral disorders	3/344	3/348
PyrexiaGeneral disorders	3/344	3/348
Herpes zosterInfections and infestations	3/344	0/348
DepressionPsychiatric disorders	3/344	1/348
GastroenteritisInfections and infestations	1/344	3/348
ColitisGastrointestinal disorders	2/344	0/348
CellulitisInfections and infestations	2/344	2/348
InfluenzaInfections and infestations	2/344	0/348

Most frequent other events

Showing 10 of 42

Most frequent other events
Event	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF
DiarrhoeaGastrointestinal disorders	76/344	96/348
Ocular icterusEye disorders	69/344	79/348
NasopharyngitisInfections and infestations	59/344	79/348
JaundiceHepatobiliary disorders	76/344	61/348
HeadacheNervous system disorders	57/344	73/348
Upper respiratory tract infectionInfections and infestations	67/344	65/348
NauseaGastrointestinal disorders	66/344	66/348
HyperbilirubinaemiaHepatobiliary disorders	42/344	39/348
Back painMusculoskeletal and connective tissue disorders	34/344	42/348
FatigueGeneral disorders	38/344	34/348

Baseline characteristics

Safety Analysis Set: participants who were randomized and received at least on dose of study drug

Age, Continuous
Age, Continuous(years)	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF	Total
Mean	37 ± 9.8	38 ± 9.6	37 ± 9.7

Sex: Female, Male
Sex: Female, Male(Participants)	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF	Total
Female	57	61	118
Male	287	287	574

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF	Total
Hispanic or Latino	97	92	189
Not Hispanic or Latino	245	253	498
Unknown or Not Reported	2	3	5

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF	Total
American Indian or Alaska Native	1	2	3
Asian	44	37	81
Black or African Heritage	65	63	128
Native Hawaiian or Pacific Islander	1	1	2
White	198	215	413
Not Permitted	2	3	5
Other	33	27	60

Region of Enrollment
Region of Enrollment(participants)	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF	Total
Australia	7	8	15
Austria	13	5	18
Belgium	7	11	18
Brazil	18	17	35
Canada	26	18	44
Denmark	0	2	2
Dominican Republic	27	31	58
France	12	19	31
Germany	17	21	38
Italy	6	15	21
Mexico	18	17	35
Netherlands	0	1	1
Portugal	9	5	14
Spain	3	4	7
Switzerland	3	12	15
Thailand	35	31	66
United Kingdom	14	18	32
United States	134	114	248

HIV-1 RNA
HIV-1 RNA(log10 copies/mL)	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF	Total
Mean	4.81 ± 0.585	4.84 ± 0.594	4.83 ± 0.589

HIV-1 RNA Category
HIV-1 RNA Category(participants)	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF	Total
≤ 100,000 copies/mL	212	205	417
> 100,000 copies/mL	132	143	275

Cluster of differentiation (CD4) Cell Count
Cluster of differentiation (CD4) Cell Count(cells/µL)	ATV+COBI+FTC/TDF	ATV+RTV+FTC/TDF	Total
Mean	353 ± 170.5	351 ± 175.5	352 ± 172.9

4 further baseline measures are reported on the registry.

Study locations

134 sites

University of Alabama at Birmingham
Birmingham, Alabama 35294, United States
Spectrum Medical Group
Phoenix, Arizona 85012, United States
Health for Life Clinic PLLC
Little Rock, Arkansas 72207, United States
Living Hope Clinical Foundation
Long Beach, California 90813, United States
Kaiser Permanente
Los Angeles, California 90027, United States
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
Los Angeles, California 90028, United States
Peter J Ruane, MD, Inc
Los Angeles, California 90036, United States
Oasis Clinic
Los Angeles, California 90059, United States
Anthony Mills MD Inc
Los Angeles, California 90069, United States
University of California, Davis Medical Center
Sacramento, California 95817, United States
Kaiser Permanente Medical Group
Sacramento, California 95825, United States
La Playa Medical Group and Clinical Research
San Diego, California 92103, United States
Metropolis Medical
San Francisco, California 94115, United States
Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California 94118, United States
Apex Research, LLC
Denver, Colorado 80220, United States
Dupont Circle Physicians Group
Washington, District of Columbia 20009, United States
Whitman-Walker Clinic
Washington, District of Columbia 20009, United States
George Washington University Medical Faculty Associates
Washington, District of Columbia 20037, United States
Therafirst Medical Center
Fort Lauderdale, Florida 33308, United States
Broward Health/Comprehensive Care Center
Fort Lauderdale, Florida 33311, United States
Midway Immunology and Research Center
Fort Pierce, Florida 34982, United States
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida 33139, United States
The Kinder Medical Group
Miami, Florida 33133, United States
University of Miami School of Medicine
Miami, Florida 33136, United States
Orlando Immunology Center
Orlando, Florida 32803, United States
Idocf/ Valuhealthmd, Llc
Orlando, Florida 32806, United States
University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
Tampa, Florida 33602, United States
Infectious Disease Research Institute Inc.
Tampa, Florida 33614, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida 33615, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia 30033, United States
Mercer University School of Medicine
Macon, Georgia 31210, United States
Howard Brown Health Center
Chicago, Illinois 60613, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland 21205, United States
Community Research Initiative of New England
Boston, Massachusetts 02215, United States
Be Well Medical Center
Berkley, Michigan 48072, United States
Henry Ford Health System
Detroit, Michigan 48202, United States
Hennepin County Medical Center
Minneapolis, Minnesota 55415, United States
CentralWest Clinical Research
St. Louis, Missouri 63108, United States
Saint Michaels Medical Center
Newark, New Jersey 07102, United States
South Jersey Infectious Disease
Somers Point, New Jersey 08244, United States
SouthWest CARE Center
Santa Fe, New Mexico 87505, United States
Montefiore Medical Center - AIDS Center
Bronx, New York 10467, United States
North Shore University Hospital
Manhasset, New York 11030, United States
Chelsea Village Medical, PC
New York, New York 10011, United States
Mt Sinai School of Medicine
New York, New York 10011, United States
Ricky K. Hsu, MD, PC
New York, New York 10011, United States
Carolinas Medical Center-Myers Park
Charlotte, North Carolina 28207, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
East Carolina University, The Brody School of Medicine
Greenville, North Carolina 27834, United States
Rosedale Infectious Diseases
Huntersville, North Carolina 28078, United States
Wake Forest University Health Sciences
Winston Salem, North Carolina 27157, United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States
Division of Infectious Diseases, Thomas Jefferson University
Philadelphia, Pennsylvania 19107, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania 19107, United States
University of South Carolina
Columbia, South Carolina 29203, United States
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas 75204, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas 76104, United States
Garcia's Family Health Group
Harlingen, Texas 78550, United States
Therapeutic Concepts, PA
Houston, Texas 77004, United States
Gordon E. Crofoot MD PA
Houston, Texas 77098, United States
Research Access Network
Houston, Texas 77098, United States
DCOL Center for Clinical Research
Longview, Texas 75605, United States
Peter Shalit, M.D.
Seattle, Washington 98104, United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226, United States
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales 2010, Australia
Taylor Square Private Clinic
Darlinghurst, New South Wales 2010, Australia
Albion Street Centre
Sydney, New South Wales 2010, Australia
Holdsworth House Medical practice
Sydney, New South Wales 2010, Australia
Melbourne Sexual Health Centre
Carlton, Victoria 3053, Australia
Alfred Hospital
Melbourne, Victoria 3004, Australia
Northside Clinic
Melbourne, Victoria 3068, Australia
LKH Graz West
Graz, A-8010, Austria
Allgemeines Krankenhaus
Vienna, 1090, Austria
Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital
Vienna, 1140, Austria
CHU Saint-Pierre University Hospital
Brussels, 1000, Belgium
Hôpital Universitaire Erasme - ULB
Brussels, 1070, Belgium
University of Ghent
Ghent, 9000, Belgium
Instituto De Pesquisa Clinica Evandro Chagas
Rio de Janeiro, RJ 21040-900, Brazil
URDIP Faculdade de Medicina do ABC
Santo Andre, Sao Paulo 09060-650, Brazil
Universidade Estadual de Campinas
Campinas, 13083-970, Brazil
Instituto De Infectologia Emilo Ribas
São Paulo, 01246-900, Brazil
Brasilmed Assistencia Medica E Pesquisas
São Paulo, 01416-000, Brazil
Crt-Dst/Aids
São Paulo, 04121-000, Brazil
Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg
Winnipeg, Manitoba R3A 1R9, Canada
Canadian Immunodeficiency Research Collaborative (CIRC) Inc.
Toronto, Ontario M5B1L6, Canada
University Health Network, Toronto General Hospital
Toronto, Ontario M5G 2N2, Canada
Clinique medicale l'Actuel
Montreal, Quebec H2L 4P9, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec H2L 5B1, Canada
Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute
Montréal, Quebec H2X 2P4, Canada
Project LORI
Montreal, H3H 1V1, Canada
Rigshospitalet, Infektionsklinik 5112
Copenhagen, 2000, Denmark
Instituto Dominicano de Estudios Virologicos - IDEV
Santo Domingo, Dominican Republic
Service des Maladies Infectieuses, CHU de Caen
Caen, 14033, France
Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales
Lyon, 69288, France
Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH
Marseille, 13009, France
CHU de Nantes Hopital de l'Hotel Dieu
Nantes, 44093, France
Department of Infectious Diseases, Saint-Louis hospital
Paris, 75010, France
Hopital Saint Antoine, Service De Maladies Infectieuses
Paris, 75012, France
Bichat Hospital
Paris, 75018, France
Tenon Hospital, UPMC
Paris, 75020, France

Showing the first 100 of 134 sites across 19 countries.

References and documents

Publications

Gallant JE, Koenig E, Andrade-Villanueva J, Chetchotisakd P, DeJesus E, Antunes F, Arasteh K, Moyle G, Rizzardini G, Fehr J, Liu Y, Zhong L, Callebaut C, Szwarcberg J, Rhee MS, Cheng AK. Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: week 48 results. J Infect Dis. 2013 Jul;208(1):32-9. doi: 10.1093/infdis/jit122. Epub 2013 Mar 26. PubMed 23532097 ↗
Gallant JE, Koenig E, Andrade-Villanueva JF, Chetchotisakd P, DeJesus E, Antunes F, Arasteh K, Rizzardini G, Fehr J, Liu HC, Abram ME, Cao H, Szwarcberg J. Brief Report: Cobicistat Compared With Ritonavir as a Pharmacoenhancer for Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate: Week 144 Results. J Acquir Immune Defic Syndr. 2015 Jul 1;69(3):338-40. doi: 10.1097/QAI.0000000000000598. PubMed 26181707 ↗
Gallant J, Moyle G, Berenguer J, Shalit P, Cao H, Liu YP, Myers J, Rosenblatt L, Yang L, Szwarcberg J. Atazanavir Plus Cobicistat: Week 48 and Week 144 Subgroup Analyses of a Phase 3, Randomized, Double-Blind, Active-Controlled Trial. Curr HIV Res. 2017;15(3):216-224. doi: 10.2174/1570162X14666161021102728. PubMed 27774892 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01108510
Lead sponsor: Gilead Sciences
Responsible party: Sponsor
First posted: Apr 22, 2010
Start date: Apr 2010
Primary completion: Nov 2011
Completion: Apr 2015
Results posted: Oct 28, 2014
Last update: May 23, 2016

Study contacts

Huyen Cao, MD

study director · Gilead Sciences

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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