Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women (WAVES)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01705574
First received: October 10, 2012
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

To evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV-1 infected, antiretroviral treatment-naïve adult women as determined by the achievement of HIV 1 RNA <50 copies/mL at Week 48


Condition Intervention Phase
Acquired Immunodeficiency Syndrome
HIV Infections
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir df
Drug: ritonavir + atazanavir + emtricitabine/tenofovir df
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • The proportion of subjects with HIV 1 RNA < 50 copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    The primary efficacy endpoint is the proportion of subjects with HIV 1 RNA <50 copies/mL at Week 48


Secondary Outcome Measures:
  • To evaluate the change in CD4+ cell count at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    The change from baseline in CD4+ cell count at Week 48


Estimated Enrollment: 510
Study Start Date: October 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: elvitegravir/cobicistat/emtricitabine/tenofovir df
Single tablet regimen of elvitegravir 150 mg/cobicistat 150mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg + placebos to match ritonavir 100 mg and atazanavir 300 mg and emtricitabine 200mg/tenofovir disoproxil fumarate 300 mg once daily
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir df
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg single table regimen administered orally with food once daily
Active Comparator: ritonavir + atazanavir + emtricitabine/tenofovir df
Ritonavir 100 mg and atazanavir 300 mg and emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg + placebo to match single tablet regimen of elvitegravir 150 mg/cobicistat 150mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg once daily
Drug: ritonavir + atazanavir + emtricitabine/tenofovir df
ritonavir 100 mg + atazanavir 300 mg + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg administered orally with food once daily
Other Names:
  • Truvada®
  • Norvir®
  • Reyataz®
  • Stribild®

Detailed Description:

Randomized, double-blinded, multicenter, active-controlled study to evaluate the safety and efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) administered as a single tablet regimen (STR) versus ritonavir-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (Truvada® or FTC/TDF) in HIV 1 infected, antiretroviral treatment-naïve adult women.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female (at birth), age ≥ 18 years
  • 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 boosted with ritonavir (ATV/r)
  • 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:

  • A new AIDS defining condition diagnosed within the 30 days
  • Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study
  • 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 pulse rate interval ≥ 220 msec
  • Current alcohol or substance use which may potentially interfere with subject 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 subject unsuitable for the study or unable to comply with the dosing requirements
  • Subjects receiving ongoing therapy with any disallowed medications, including drugs not to be used with EVG, COBI, FTC, TDF, ATV, RTV; or subjects with any known allergies to the excipients of EVG/COBI/FTC/TDF STR, Truvada® tablets, atazanavir capsules or ritonavir tablets
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705574

  Hide Study Locations
Locations
United States, California
University of Southern California AIDS Clinical Trials Group
Los Angeles, California, United States, 90033
University of California, Davis Medical Center
Sacramento, California, United States, 95817
United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037
Whitman-Walker Health
Washington, District of Columbia, United States, 20009
United States, Florida
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34982
University of Miami
Miami, Florida, United States, 33136
Orlando Immunology Center
Orlando, Florida, United States, 32803
IDOCF/ValuhealthMD
Orlando, Florida, United States, 32806
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, United States, 33614
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States, 33401
United States, Georgia
Emory HIV/AIDS Clinical Trials Unit
Atlanta, Georgia, United States, 30308
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
Mercer University Mercer Medicine
Macon, Georgia, United States, 31201
Chatham County Health Daprtment
Savannah, Georgia, United States, 31401
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
LSUHSC HIV Out-Patient Clinic Research
New Orleans, Louisiana, United States, 70119
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
The Research Institute
Springfield, Massachusetts, United States, 01105
United States, New Jersey
New Jersey Medical School
Newark, New Jersey, United States, 07103
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10040
New York Hospital Queens
Flushing, New York, United States, 01135
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina AIDS Clinical Trials Unit
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University The Brody School of Medicine Div. of Infectious Diseases
Greenville, North Carolina, United States, 27834
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Wexner Medical Center at the Ohio State University
Columbus, Ohio, United States, 43210
The University of Toledo Medical Center
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18102
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Temple University Hospital- Internal General Medicine
Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
UT - Physicians
Bellaire, Texas, United States, 77401
AIDS Arms, Inc./Trinity Health & Wellness Center
Dallas, Texas, United States, 75208
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, United States, 75208
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
Belgium
Institute of Tropical Medicine
Antwerp, Belgium, 2000
Saint-Pierre University Hospital
Brussels, Belgium, 1000
Hôpitaux IRIS SUD
Brussels, Belgium, 1050
Dominican Republic
Instituto Dominicano de Estudio Virologicos - IDEV
Santo Domingo, Dominican Republic, 10514
Salvador B Gautier Hospital, Infectious Diseases Department
Santo Domingo, Dominican Republic, 10514
France
Maladies Infectieuses Dpt
Paris, France, 75651
Hopital Tenon
Paris, France, 75020
Hôpital Bichat Claude Bernard
Paris, France, 75018
Hopitaux Universitaires Strasbourg
Strasbourg, France, 67091
Italy
Department of Health Sciences - University of Milan - San Paolo Hospital
Milan, Italy, 20142
Luigi Sacco Hospital, Milan
Milan, Italy, 20157
Clinica Malattie Infettive, Azienda Ospedaliero Universitaria
Modena, Italy, 41124
Mexico
Hospital Civil de Guadalajara Dr Juan I Menchaca
Guadalajara, Jalisco, Mexico, 44340
Hospital Civil de Guadalajara
Guadalajara, Mexico, 44280
Intituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico, 14000
Portugal
Hospital Fernando Fonseca
Amadora, Portugal, 2720-276
Hospital de Santa Maria - Serviço de Doenças Infecciosas
Lisboa, Portugal, 1649-035
Hospital Dos Capuchos, Centro Hospitalar De Lisboa Central
Lisboa, Portugal, 1200-110
centro Hospitalar S. João
Porto, Portugal, 4200-319
Centro Hospitalar do Porto - Hospital Joaquim Urbano
Porto, Portugal, 4369-004
Hospital de Santarém
Santarem, Portugal, 2005-177
Puerto Rico
Maternal Infants Studies Center (CEMI)
San Juan, Puerto Rico, 00936
Russian Federation
Republic of Altay Center for Prevention and Control of AIDS and Infectious Diseases
Barnaul, Russian Federation, 656010
Sverdlovsk Regional Center for Prevention and control of AIDS and Infectious Diseases
Ekaterinburg, Russian Federation, 620102
GUZ "Irkutsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
Irkutsk, Russian Federation, 664043
Khabarovsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases
Khabarovsk, Russian Federation, 680031
"Infectious Diseases Center", LLC
Koltsovo, Russian Federation, 630559
State Budget Healthcare Institution "Clinical Centre for AIDS and Infectious Diseases Fight and Prevention" of Krasnodar regio Department for Healthcare
Krasnodar, Russian Federation, 350015
GUZ "Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases"
Krasnoyarsk, Russian Federation, 660049
GUZ "Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases"
Lipetsk, Russian Federation, 398043
State Healthcare Institution Infectious Clinical Hospital #2 of Moscow City Healthcare Department
Moscow, Russian Federation, 105275
Infectious Hospital 2
Moscow, Russian Federation, 105275
GKUZ MO "Center for Prevention and Treatment of AIDS and Infectious Diseases" (Moscow Regional AIDS Center)
Moscow, Russian Federation, 129110
State Budget Health Institution of Nizhniy Novgorod "Nizhniy Novgorod Regional Center of prophylaxis and treatment of AIDS and Infectious Diseases
Nizhniy Novgorod, Russian Federation, 603950
Budgetary Medical Facility of the Orel Region "Orel Regional Center for Prevention and Control of AIDS and Infectious Diseases"
Orel, Russian Federation, 302040
Perm Regional Center for Prevention and Control of AIDS and Infectious Diseases
Perm, Russian Federation, 614000
St.Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, In-patient Department
Saint-Petersburg, Russian Federation, 190020
Saint-Petersburg GUZ "Clinical Infectious Hospital named after S.P.Botkin"
Saint-Petersburg, Russian Federation, 191167
St.Petersburg GUZ "Center for Prevention and Control of AIDS and Infectious Diseases", Out-patient Department
Saint-Petersburg, Russian Federation, 190103
Federal State Budgetary Institution "Republic Clinical Infectious Hospital"
Saint-Petersburg, Russian Federation, 196645
Saratov Regional Centre for Treatment and Prevention of AIDS and Infectious Diseases
Saratov, Russian Federation, 410009
Volgograd Regional Center for Prevention and Control of AIDS and Infectious Diseases
Volgograd, Russian Federation, 400040
GUZ "Voronezh Regional Center for Prevention and Control of AIDS and Infectious Diseases"
Voronezh, Russian Federation, 394065
Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, Thailand, 10330
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital
Bangkok, Thailand, 10700
Chiang Mai University
Chiang Mai, Thailand, 50200
Bamrasnaradura lnfectious Disease Institute
Nontaburi, Thailand, 11000
Uganda
Joint Clinical Research Centre
Kampala, Uganda
United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom, NW32QG
Imperial College Healthcare NHS Trust
London, United Kingdom, W21NY
Barts Healthe NHS Trust
London, United Kingdom, E11BB
Kings College London
London, United Kingdom, SE59RJ
Homerton University Hospital NHS Foundation Trust
London, United Kingdom, E96SR
St George's Healthcare NHS Trust
London, United Kingdom, SW17 0QT
Queen Elizabeth Hospital, South London Healthcare NHS Trust
London, United Kingdom, SE18 4QH
Mortimer Market Centre and Central and North West London NHS Foundation Trust
London, United Kingdom, WC1E 6JB
Royal Berkshire NHS Foundation Trust
Reading, United Kingdom, RG1 5LE
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Huyen Cao, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01705574     History of Changes
Other Study ID Numbers: GS-US-236-0128, 2012-003708-11
Study First Received: October 10, 2012
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV-1
HIV
Treatment-Naive
Women
WAVES

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Ritonavir
Atazanavir
Tenofovir
Tenofovir disoproxil
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014