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Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women (WAVES)

Primary Purpose

Acquired Immunodeficiency Syndrome, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
E/C/F/TDF
ATV
RTV
FTC/TDF
E/C/F/TDF Placebo
ATV Placebo
RTV Placebo
FTC/TDF Placebo
E/C/F/TAF
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Immunodeficiency Syndrome focused on measuring HIV-1, HIV, Treatment-Naive, Women, WAVES

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Key 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 (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.

Key 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 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • University of Southern California AIDS Clinical Trials Group
  • University of California, Davis Medical Center
  • Whitman-Walker Health
  • George Washington University Medical Faculty Associates
  • Midway Immunology and Research Center
  • University of Miami
  • Orlando Immunology Center
  • IDOCF/ValuhealthMD
  • St. Joseph's Hospital Comprehensive Research Institute
  • Triple O Research Institute, P.A.
  • AIDS Research Consortium of Atlanta
  • Emory HIV/AIDS Clinical Trials Unit
  • Infectious Disease Specialists of Atlanta
  • Mercer University Mercer Medicine
  • Chatham County Health Daprtment
  • University of Louisville
  • LSUHSC HIV Out-Patient Clinic Research
  • Brigham and Women's Hospital
  • The Research Institute
  • Saint Michael's Medical Center
  • New Jersey Medical School
  • Montefiore Medical Center
  • New York Hospital Queens
  • University of Rochester
  • University of North Carolina AIDS Clinical Trials Unit
  • Duke University Medical Center
  • East Carolina University The Brody School of Medicine Div. of Infectious Diseases
  • Wake Forest University Health Sciences
  • Wexner Medical Center at the Ohio State University
  • The University of Toledo Medical Center
  • Lehigh Valley Health Network
  • Philadelphia FIGHT
  • Thomas Jefferson University
  • Temple University Hospital- Internal General Medicine
  • The Miriam Hospital
  • Medical University of South Carolina
  • Central Texas Clinical Research
  • UT - Physicians
  • AIDS Arms, Inc./Trinity Health & Wellness Center
  • North Texas Infectious Diseases Consultants, PA
  • Therapeutic Concepts, PA
  • Institute of Tropical Medicine
  • Saint-Pierre University Hospital
  • Hôpitaux IRIS SUD
  • Instituto Dominicano de Estudio Virologicos - IDEV
  • Salvador B Gautier Hospital, Infectious Diseases Department
  • Hôpital Bichat Claude Bernard
  • Hopital Tenon
  • Maladies Infectieuses Dpt
  • Hopitaux Universitaires Strasbourg
  • Department of Health Sciences - University of Milan - San Paolo Hospital
  • Luigi Sacco Hospital, Milan
  • Clinica Malattie Infettive, Azienda Ospedaliero Universitaria
  • Hospital Civil de Guadalajara Dr Juan I Menchaca
  • Hospital Civil de Guadalajara
  • Intituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
  • Hospital Fernando Fonseca
  • Hospital Dos Capuchos, Centro Hospitalar De Lisboa Central
  • Hospital de Santa Maria - Serviço de Doenças Infecciosas
  • centro Hospitalar S. João
  • Centro Hospitalar do Porto - Hospital Joaquim Urbano
  • Hospital de Santarém
  • Maternal Infants Studies Center (CEMI)
  • Republic of Altay Center for Prevention and Control of AIDS and Infectious Diseases
  • Sverdlovsk Regional Center for Prevention and control of AIDS and Infectious Diseases
  • GUZ "Irkutsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
  • Khabarovsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases
  • "Infectious Diseases Center", LLC
  • State Budget Healthcare Institution "Clinical Centre for AIDS and Infectious Diseases Fight and Prevention" of Krasnodar regio Department for Healthcare
  • GUZ "Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases"
  • GUZ "Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases"
  • Infectious Hospital 2
  • State Healthcare Institution Infectious Clinical Hospital #2 of Moscow City Healthcare Department
  • GKUZ MO "Center for Prevention and Treatment of AIDS and Infectious Diseases" (Moscow Regional AIDS Center)
  • State Budget Health Institution of Nizhniy Novgorod "Nizhniy Novgorod Regional Center of prophylaxis and treatment of AIDS and Infectious Diseases
  • Budgetary Medical Facility of the Orel Region "Orel Regional Center for Prevention and Control of AIDS and Infectious Diseases"
  • Perm Regional Center for Prevention and Control of AIDS and Infectious Diseases
  • St.Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, In-patient Department
  • St.Petersburg GUZ "Center for Prevention and Control of AIDS and Infectious Diseases", Out-patient Department
  • Saint-Petersburg GUZ "Clinical Infectious Hospital named after S.P.Botkin"
  • Federal State Budgetary Institution "Republic Clinical Infectious Hospital"
  • Saratov Regional Centre for Treatment and Prevention of AIDS and Infectious Diseases
  • Volgograd Regional Center for Prevention and Control of AIDS and Infectious Diseases
  • GUZ "Voronezh Regional Center for Prevention and Control of AIDS and Infectious Diseases"
  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
  • Faculty of Medicine Ramathibodi Hospital, Mahidol University
  • Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital
  • Chiang Mai University
  • Bamrasnaradura lnfectious Disease Institute
  • Joint Clinical Research Centre
  • Barts Healthe NHS Trust
  • Homerton University Hospital NHS Foundation Trust
  • Royal Free London NHS Foundation Trust
  • Queen Elizabeth Hospital, South London Healthcare NHS Trust
  • Kings College London
  • St George's Healthcare NHS Trust
  • Imperial College Healthcare NHS Trust
  • Mortimer Market Centre and Central and North West London NHS Foundation Trust
  • Royal Berkshire NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

E/C/F/TDF

ATV + RTV+ FTC/TDF

Open-Label Extension Phase

Arm Description

E/C/F/TDF + ATV placebo + RTV placebo + FTC/TDF placebo

ATV + RTV + FTC/TDF + E/C/F/TDF placebo

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Secondary Outcome Measures

Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 for the STB Group as Determined by the US FDA-Defined Snapshot Algorithm
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Percentage of Participants Receiving STB or ATV+RTV+TVD With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 of the open-label phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase

Full Information

First Posted
October 10, 2012
Last Updated
September 5, 2019
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01705574
Brief Title
Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women
Acronym
WAVES
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 24, 2012 (Actual)
Primary Completion Date
February 9, 2015 (Actual)
Study Completion Date
September 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome, HIV Infections
Keywords
HIV-1, HIV, Treatment-Naive, Women, WAVES

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
583 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E/C/F/TDF
Arm Type
Experimental
Arm Description
E/C/F/TDF + ATV placebo + RTV placebo + FTC/TDF placebo
Arm Title
ATV + RTV+ FTC/TDF
Arm Type
Active Comparator
Arm Description
ATV + RTV + FTC/TDF + E/C/F/TDF placebo
Arm Title
Open-Label Extension Phase
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
E/C/F/TDF
Other Intervention Name(s)
Stribild®
Intervention Description
150/150/200/300 mg FDC tablet administered orally with food once daily
Intervention Type
Drug
Intervention Name(s)
ATV
Other Intervention Name(s)
Reyataz®
Intervention Description
300 mg capsule administered orally with food once daily
Intervention Type
Drug
Intervention Name(s)
RTV
Other Intervention Name(s)
Norvir®
Intervention Description
100 mg tablet administered orally with food once daily
Intervention Type
Drug
Intervention Name(s)
FTC/TDF
Other Intervention Name(s)
Truvada®
Intervention Description
200/300 mg tablet administered orally with food once daily
Intervention Type
Drug
Intervention Name(s)
E/C/F/TDF Placebo
Intervention Description
Tablet administered orally with food once daily
Intervention Type
Drug
Intervention Name(s)
ATV Placebo
Intervention Description
Tablet administered orally with food once daily
Intervention Type
Drug
Intervention Name(s)
RTV Placebo
Intervention Description
Capsule administered orally with food once daily
Intervention Type
Drug
Intervention Name(s)
FTC/TDF Placebo
Intervention Description
Tablet administered orally with food once daily
Intervention Type
Drug
Intervention Name(s)
E/C/F/TAF
Other Intervention Name(s)
Genvoya®
Intervention Description
150/150/200/10 mg FDC tablet administered orally with food once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm
Description
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase
Time Frame
Baseline; Week 48
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 for the STB Group as Determined by the US FDA-Defined Snapshot Algorithm
Description
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame
Week 96
Title
Percentage of Participants Receiving STB or ATV+RTV+TVD With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase
Description
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 of the open-label phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame
Open-Label Extension Week 48
Title
Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase
Time Frame
Baseline; Open-Label Extension Week 48

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
27562742
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women

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