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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)

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acquired Immunodeficiency Syndrome; HIV Infections

Intervention: EVG/COBI/FTC/TDF (Drug); RTV (Drug); ATV (Drug); FTC/TDF (Drug); Placebo to match EVG/COBI/FTC/TDF (Drug); Placebo to match RTV (Drug); Placebo to match ATV (Drug); Placebo to match FTC/TDF (Drug); EVG/COBI/FTC/TAF (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Huyen Cao, MD, Study Director, Affiliation: Gilead Sciences

Summary

This study will evaluate the safety, efficacy, and tolerability of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regiment (STR) versus ritonavir (RTV)-boosted atazanavir (ATV) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women. This study will consist of two phases: Double-Blinded Treatment Phase (60 weeks) and Open Label Extension (OLE) Phase (48 weeks). Participants who are virologically suppressed at Week 48 during the Double-Blinded Treatment Phase will have the option to enter the OLE Phase. Participants randomized to the EVG/COBI/FTC/TDF arm in the Double-Blinded Treatment Phase will continue on open-label EVG/COBI/FTC/TDF STR while participants randomized to the RTV+ATV+FTC/TDF arm will be rerandomized in a 3: 1 ratio to receive either open label elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) STR or RTV+ATV+FTC/TDF.

Clinical Details

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-Nave Women

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The proportion of participants with HIV 1 RNA < 50 copies/mL at Week 48 of the double-blind phase as defined by the FDA snapshot analysis

Secondary outcome:

Change from baseline in CD4+ cell count at Week 48 of the double-blind phase

Proportion of participants receiving open-label EVG/COBI/FTC/TDF with HIV-1 RNA < 50 copies/mL (by FDA snapshot) at Week 48 of the OLE

Proportion of participants receiving EVG/COBI/FTC/TAF or RTV+ATV+FTC/TDF with HIV-RNA <50 copies/mL (by FDA snapshot) at Week 48 of the OLE

Change in CD4+ cell count at Week 48 of the OLE

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

- 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 EVG, COBI, FTC, TDF, ATV, RTV; or females with any known allergies to the excipients of EVG/COBI/FTC/TDF STR, Truvada® tablets, atazanavir capsules or ritonavir tablets

Locations and Contacts

Institute of Tropical Medicine, Antwerp 2000, Belgium

Hôpitaux IRIS SUD, Brussels 1050, Belgium

Saint-Pierre University Hospital, Brussels 1000, Belgium

Instituto Dominicano de Estudio Virologicos - IDEV, Santo Domingo 10514, Dominican Republic

Salvador B Gautier Hospital, Infectious Diseases Department, Santo Domingo 10514, Dominican Republic

Hopital Tenon, Paris 75020, France

Hôpital Bichat Claude Bernard, Paris 75018, France

Maladies Infectieuses Dpt, Paris 75651, France

Hopitaux Universitaires Strasbourg, Strasbourg 67091, France

Department of Health Sciences - University of Milan - San Paolo Hospital, Milan 20142, Italy

Luigi Sacco Hospital, Milan, Milan 20157, Italy

Clinica Malattie Infettive, Azienda Ospedaliero Universitaria, Modena 41124, Italy

Hospital Civil de Guadalajara, Guadalajara 44280, Mexico

Intituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14000, Mexico

Hospital Fernando Fonseca, Amadora 2720-276, Portugal

Hospital de Santa Maria - Serviço de Doenças Infecciosas, Lisboa 1649-035, Portugal

Hospital Dos Capuchos, Centro Hospitalar De Lisboa Central, Lisboa 1200-110, Portugal

Centro Hospitalar do Porto - Hospital Joaquim Urbano, Porto 4369-004, Portugal

centro Hospitalar S. João, Porto 4200-319, Portugal

Hospital de Santarém, Santarem 2005-177, Portugal

Maternal Infants Studies Center (CEMI), San Juan 00936, Puerto Rico

Republic of Altay Center for Prevention and Control of AIDS and Infectious Diseases, Barnaul 656010, Russian Federation

Sverdlovsk Regional Center for Prevention and control of AIDS and Infectious Diseases, Ekaterinburg 620102, Russian Federation

GUZ "Irkutsk Regional Center for Prevention and Control of AIDS and Infectious Diseases, Irkutsk 664043, Russian Federation

Khabarovsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases, Khabarovsk 680031, Russian Federation

"Infectious Diseases Center", LLC, Koltsovo 630559, Russian Federation

State Budget Healthcare Institution "Clinical Centre for AIDS and Infectious Diseases Fight and Prevention" of Krasnodar regio Department for Healthcare, Krasnodar 350015, Russian Federation

GUZ "Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases", Krasnoyarsk 660049, Russian Federation

GUZ "Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases", Lipetsk 398043, Russian Federation

GKUZ MO "Center for Prevention and Treatment of AIDS and Infectious Diseases" (Moscow Regional AIDS Center), Moscow 129110, Russian Federation

Infectious Hospital 2, Moscow 105275, Russian Federation

State Healthcare Institution Infectious Clinical Hospital #2 of Moscow City Healthcare Department, Moscow 105275, Russian Federation

State Budget Health Institution of Nizhniy Novgorod "Nizhniy Novgorod Regional Center of prophylaxis and treatment of AIDS and Infectious Diseases, Nizhniy Novgorod 603950, Russian Federation

Budgetary Medical Facility of the Orel Region "Orel Regional Center for Prevention and Control of AIDS and Infectious Diseases", Orel 302040, Russian Federation

Perm Regional Center for Prevention and Control of AIDS and Infectious Diseases, Perm 614000, Russian Federation

Federal State Budgetary Institution "Republic Clinical Infectious Hospital", Saint-Petersburg 196645, Russian Federation

Saint-Petersburg GUZ "Clinical Infectious Hospital named after S.P.Botkin", Saint-Petersburg 191167, Russian Federation

St.Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, In-patient Department, Saint-Petersburg 190020, Russian Federation

St.Petersburg GUZ "Center for Prevention and Control of AIDS and Infectious Diseases", Out-patient Department, Saint-Petersburg 190103, Russian Federation

Saratov Regional Centre for Treatment and Prevention of AIDS and Infectious Diseases, Saratov 410009, Russian Federation

Volgograd Regional Center for Prevention and Control of AIDS and Infectious Diseases, Volgograd 400040, Russian Federation

GUZ "Voronezh Regional Center for Prevention and Control of AIDS and Infectious Diseases", Voronezh 394065, Russian Federation

Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital, Bangkok 10700, Thailand

Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok 10330, Thailand

Chiang Mai University, Chiang Mai 50200, Thailand

Bamrasnaradura lnfectious Disease Institute, Nontaburi 11000, Thailand

Joint Clinical Research Centre, Kampala, Uganda

Barts Healthe NHS Trust, London E11BB, United Kingdom

Homerton University Hospital NHS Foundation Trust, London E96SR, United Kingdom

Imperial College Healthcare NHS Trust, London W21NY, United Kingdom

Kings College London, London SE59RJ, United Kingdom

Mortimer Market Centre and Central and North West London NHS Foundation Trust, London WC1E 6JB, United Kingdom

Queen Elizabeth Hospital, South London Healthcare NHS Trust, London SE18 4QH, United Kingdom

Royal Free London NHS Foundation Trust, London NW32QG, United Kingdom

St George's Healthcare NHS Trust, London SW17 0QT, United Kingdom

Royal Berkshire NHS Foundation Trust, Reading RG1 5LE, United Kingdom

University of Southern California AIDS Clinical Trials Group, Los Angeles, California 90033, United States

University of California, Davis Medical Center, Sacramento, California 95817, United States

George Washington University Medical Faculty Associates, Washington, District of Columbia 20037, United States

Whitman-Walker Health, Washington, District of Columbia 20009, United States

Midway Immunology and Research Center, Fort Pierce, Florida 34982, United States

University of Miami, Miami, Florida 33136, United States

IDOCF/ValuhealthMD, Orlando, Florida 32806, United States

Orlando Immunology Center, Orlando, Florida 32803, United States

St. Joseph's Hospital Comprehensive Research Institute, Tampa, Florida 33614, United States

Triple O Research Institute, P.A., West Palm Beach, Florida 33401, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States

Emory HIV/AIDS Clinical Trials Unit, Atlanta, Georgia 30308, United States

Infectious Disease Specialists of Atlanta, Decatur, Georgia 30033, United States

Mercer University Mercer Medicine, Macon, Georgia 31201, United States

Chatham County Health Daprtment, Savannah, Georgia 31401, United States

Hospital Civil de Guadalajara Dr Juan I Menchaca, Guadalajara, Jalisco 44340, Mexico

University of Louisville, Louisville, Kentucky 40202, United States

LSUHSC HIV Out-Patient Clinic Research, New Orleans, Louisiana 70119, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

The Research Institute, Springfield, Massachusetts 01105, United States

New Jersey Medical School, Newark, New Jersey 07103, United States

Saint Michael's Medical Center, Newark, New Jersey 07102, United States

Montefiore Medical Center, Bronx, New York 10040, United States

New York Hospital Queens, Flushing, New York 01135, United States

University of Rochester, Rochester, New York 14642, United States

University of North Carolina AIDS Clinical Trials Unit, Chapel Hill, North Carolina 27599, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

East Carolina University The Brody School of Medicine Div. of Infectious Diseases, Greenville, North Carolina 27834, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

Wexner Medical Center at the Ohio State University, Columbus, Ohio 43210, United States

The University of Toledo Medical Center, Toledo, Ohio 43614, United States

Lehigh Valley Health Network, Allentown, Pennsylvania 18102, United States

Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States

Temple University Hospital- Internal General Medicine, Philadelphia, Pennsylvania 19140, United States

Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States

The Miriam Hospital, Providence, Rhode Island 02906, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Central Texas Clinical Research, Austin, Texas 78705, United States

UT - Physicians, Bellaire, Texas 77401, United States

AIDS Arms, Inc./Trinity Health & Wellness Center, Dallas, Texas 75208, United States

North Texas Infectious Diseases Consultants, PA, Dallas, Texas 75208, United States

Therapeutic Concepts, PA, Houston, Texas 77004, United States

Additional Information

Starting date: October 2012
Last updated: March 20, 2015

Page last updated: August 23, 2015

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