Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women
NCT ID: NCT01705574
Last Updated: 2019-09-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
583 participants
INTERVENTIONAL
2012-10-24
2018-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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E/C/F/TDF
E/C/F/TDF + ATV placebo + RTV placebo + FTC/TDF placebo
E/C/F/TDF
150/150/200/300 mg FDC tablet administered orally with food once daily
ATV Placebo
Tablet administered orally with food once daily
RTV Placebo
Capsule administered orally with food once daily
FTC/TDF Placebo
Tablet administered orally with food once daily
ATV + RTV+ FTC/TDF
ATV + RTV + FTC/TDF + E/C/F/TDF placebo
ATV
300 mg capsule administered orally with food once daily
RTV
100 mg tablet administered orally with food once daily
FTC/TDF
200/300 mg tablet administered orally with food once daily
E/C/F/TDF Placebo
Tablet administered orally with food once daily
Open-Label Extension Phase
After 48 weeks of blinded treatment, participants will continue to take blinded study drug for 12 weeks and return for an unblinding visit at Week 60. Participants who are virologically suppressed at Week 48 during the double-blinded treatment phase will have the option to enter the open-label extension phase. Participants randomized to the E/C/F/TDF arm will continue to receive open-label E/C/F/TDF and participants randomized to the ATV+ RTV + FTC/TDF arm will be re-randomized to receive either open-label elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or open-label ATV + RTV+ FTC/TDF.
E/C/F/TDF
150/150/200/300 mg FDC tablet administered orally with food once daily
ATV
300 mg capsule administered orally with food once daily
RTV
100 mg tablet administered orally with food once daily
FTC/TDF
200/300 mg tablet administered orally with food once daily
E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally with food once daily
Interventions
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E/C/F/TDF
150/150/200/300 mg FDC tablet administered orally with food once daily
ATV
300 mg capsule administered orally with food once daily
RTV
100 mg tablet administered orally with food once daily
FTC/TDF
200/300 mg tablet administered orally with food once daily
E/C/F/TDF Placebo
Tablet administered orally with food once daily
ATV Placebo
Tablet administered orally with food once daily
RTV Placebo
Capsule administered orally with food once daily
FTC/TDF Placebo
Tablet administered orally with food once daily
E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally with food once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to understand and sign a written informed consent form
* Plasma HIV-1 RNA levels ≥ 500 copies/mL
* No prior use of any approved or investigational antiretroviral drug for any length of time
* Screening genotype report must show sensitivity to emtricitabine (FTC), tenofovir disoproxil fumarate (TDF) and atazanavir (ATV) boosted with ritonavir (RTV)
* Normal ECG
* Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula
* Hepatic transaminases ≤ 5 x upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 mg/dL
* Adequate hematologic function
* Serum amylase ≤ 5 x ULN
* Women of childbearing potential must agree to utilize protocol recommended contraception methods or be non-heterosexually active, or practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug
* Women 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.
Exclusion Criteria
* Females receiving drug treatment for Hepatitis C, or females who are anticipated to receive treatment for Hepatitis C during the course of the study
* Females experiencing decompensated cirrhosis
* Females who are breastfeeding
* Positive serum pregnancy test (female of childbearing potential)
* Have an implanted defibrillator or pacemaker
* Have an ECG pulse rate interval ≥ 220 msec
* Current alcohol or substance use which may potentially interfere with the female's study compliance
* 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 requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
* Participation in any other clinical trial without prior approval
* Any other clinical condition or prior therapy that would make the female unsuitable for the study or unable to comply with the dosing requirements
* Females receiving ongoing therapy with any disallowed medications, including drugs not to be used with elvitegravir, cobicistat, FTC, TDF, ATV, RTV; or females with any known allergies to the excipients of Stribild® tablets, Truvada® tablets, atazanavir capsules or ritonavir tablets
18 Years
FEMALE
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Southern California AIDS Clinical Trials Group
Los Angeles, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Whitman-Walker Health
Washington D.C., District of Columbia, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
University of Miami
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
IDOCF/ValuhealthMD
Orlando, Florida, United States
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Emory HIV/AIDS Clinical Trials Unit
Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Mercer University Mercer Medicine
Macon, Georgia, United States
Chatham County Health Daprtment
Savannah, Georgia, United States
University of Louisville
Louisville, Kentucky, United States
LSUHSC HIV Out-Patient Clinic Research
New Orleans, Louisiana, United States
The Research Institute
Springfield, Massachusetts, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
New Jersey Medical School
Newark, New Jersey, United States
New York Hospital Queens
Flushing, New York, United States
University of Rochester
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina AIDS Clinical Trials Unit
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University The Brody School of Medicine Div. of Infectious Diseases
Greenville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Wexner Medical Center at the Ohio State University
Columbus, Ohio, United States
The University of Toledo Medical Center
Toledo, Ohio, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University Hospital- Internal General Medicine
Philadelphia, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Central Texas Clinical Research
Austin, Texas, United States
UT - Physicians
Bellaire, Texas, United States
AIDS Arms, Inc./Trinity Health & Wellness Center
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
Institute of Tropical Medicine
Antwerp, , Belgium
Saint-Pierre University Hospital
Brussels, , Belgium
Hôpitaux IRIS SUD
Brussels, , Belgium
Instituto Dominicano de Estudio Virologicos - IDEV
Santo Domingo, , Dominican Republic
Salvador B Gautier Hospital, Infectious Diseases Department
Santo Domingo, , Dominican Republic
Hôpital Bichat Claude Bernard
Paris, , France
Hopital Tenon
Paris, , France
Maladies Infectieuses Dpt
Paris, , France
Hopitaux Universitaires Strasbourg
Strasbourg, , France
Department of Health Sciences - University of Milan - San Paolo Hospital
Milan, , Italy
Luigi Sacco Hospital, Milan
Milan, , Italy
Clinica Malattie Infettive, Azienda Ospedaliero Universitaria
Modena, , Italy
Hospital Civil de Guadalajara Dr Juan I Menchaca
Guadalajara, Jalisco, Mexico
Hospital Civil de Guadalajara
Guadalajara, , Mexico
Intituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, , Mexico
Hospital Fernando Fonseca
Amadora, , Portugal
Hospital Dos Capuchos, Centro Hospitalar De Lisboa Central
Lisbon, , Portugal
Hospital de Santa Maria - Serviço de Doenças Infecciosas
Lisbon, , Portugal
centro Hospitalar S. João
Porto, , Portugal
Centro Hospitalar do Porto - Hospital Joaquim Urbano
Porto, , Portugal
Hospital de Santarém
Santarém, , Portugal
Maternal Infants Studies Center (CEMI)
San Juan, , Puerto Rico
Republic of Altay Center for Prevention and Control of AIDS and Infectious Diseases
Barnaul, , Russia
GUZ "Irkutsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
Irkutsk, , Russia
Khabarovsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases
Khabarovsk, , Russia
"Infectious Diseases Center", LLC
Koltsovo, , Russia
State Budget Healthcare Institution "Clinical Centre for AIDS and Infectious Diseases Fight and Prevention" of Krasnodar regio Department for Healthcare
Krasnodar, , Russia
GUZ "Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases"
Krasnoyarsk, , Russia
GUZ "Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases"
Lipetsk, , Russia
Infectious Hospital 2
Moscow, , Russia
State Healthcare Institution Infectious Clinical Hospital #2 of Moscow City Healthcare Department
Moscow, , Russia
GKUZ MO "Center for Prevention and Treatment of AIDS and Infectious Diseases" (Moscow Regional AIDS Center)
Moscow, , Russia
State Budget Health Institution of Nizhniy Novgorod "Nizhniy Novgorod Regional Center of prophylaxis and treatment of AIDS and Infectious Diseases
Nizhny Novgorod, , Russia
Budgetary Medical Facility of the Orel Region "Orel Regional Center for Prevention and Control of AIDS and Infectious Diseases"
Oryol, , Russia
Perm Regional Center for Prevention and Control of AIDS and Infectious Diseases
Perm, , Russia
St.Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, In-patient Department
Saint Petersburg, , Russia
St.Petersburg GUZ "Center for Prevention and Control of AIDS and Infectious Diseases", Out-patient Department
Saint Petersburg, , Russia
Saint-Petersburg GUZ "Clinical Infectious Hospital named after S.P.Botkin"
Saint Petersburg, , Russia
Federal State Budgetary Institution "Republic Clinical Infectious Hospital"
Saint Petersburg, , Russia
Saratov Regional Centre for Treatment and Prevention of AIDS and Infectious Diseases
Saratov, , Russia
Volgograd Regional Center for Prevention and Control of AIDS and Infectious Diseases
Volgograd, , Russia
GUZ "Voronezh Regional Center for Prevention and Control of AIDS and Infectious Diseases"
Voronezh, , Russia
Sverdlovsk Regional Center for Prevention and control of AIDS and Infectious Diseases
Yekaterinburg, , Russia
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, , Thailand
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, , Thailand
Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital
Bangkok, , Thailand
Chiang Mai University
Chiang Mai, , Thailand
Bamrasnaradura lnfectious Disease Institute
Nonthaburi, , Thailand
Joint Clinical Research Centre
Kampala, , Uganda
Barts Healthe NHS Trust
London, , United Kingdom
Homerton University Hospital NHS Foundation Trust
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Queen Elizabeth Hospital, South London Healthcare NHS Trust
London, , United Kingdom
Kings College London
London, , United Kingdom
St George's Healthcare NHS Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Mortimer Market Centre and Central and North West London NHS Foundation Trust
London, , United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, , United Kingdom
Countries
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References
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Squires K, Kityo C, Hodder S, Johnson M, Voronin E, Hagins D, Avihingsanon A, Koenig E, Jiang S, White K, Cheng A, Szwarcberg J, Cao H. Integrase inhibitor versus protease inhibitor based regimen for HIV-1 infected women (WAVES): a randomised, controlled, double-blind, phase 3 study. Lancet HIV. 2016 Sep;3(9):e410-e420. doi: 10.1016/S2352-3018(16)30016-9. Epub 2016 May 27.
Hodder S, Squires K, Gathe J, Kityo C, Supparatpinyo K, Moshkovich G, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Presented at Interscience Conference on Antimicrobial Agents and Chemotherapy and International Congress of Chemotherapy and Infection (ICAAC/ICC) 2015; September 17-21; San Diego, CA.
Squires K, Kityo C, Hodder S, Hagins D, Avihingsanon A, Plotnikova Y, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Poster no. MOLBPE08. Presented at 8th International Antiviral Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, 2015; 19-22 July, Vancouver, BC, Canada.
Hodder S, Kityo C, Koenig E, Mussini C, Post F, Romanova S, et al. Genotypic analysis of the global clinical trial of treatment-naive women. Abstract 16. Presented at 5th International Workshop on HIV & Women, 2015; 21-22 February, Seattle, WA.
Squires K, Hodder S, Kityo C, Clumeck N, Johnson M, Plotnikova Y, et al. Enrollment in the Women's Antiretroviral Efficacy and Safety study (WAVES), a Phase 3 global study assessing antiretroviral regimen in treatment-naive women. Abstract 54. Presented at 5th International Workshop on HIV & Women, 2015; 21-22 February, Seattle, WA.
Other Identifiers
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2012-003708-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-236-0128
Identifier Type: -
Identifier Source: org_study_id
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