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