CompletedNCT01705574WAVESUpdated Sep 20, 2019Results posted

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

A Phase 3 interventional study of E/C/F/TDF and ATV in Acquired Immunodeficiency Syndrome and HIV Infections, sponsored by Gilead Sciences. Completed at 99 sites in 12 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-20.

Sponsored by Gilead Sciences · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 583
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study 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.

Conditions studied

Acquired Immunodeficiency Syndrome
HIV Infections

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Keywords

HIV-1
HIV
Treatment-Naive
Women
WAVES

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 583 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 583 participants (actual)

Study arms

Experimental
E/C/F/TDF
E/C/F/TDF + ATV placebo + RTV placebo + FTC/TDF placebo
Drug: E/C/F/TDF · Drug: ATV Placebo · Drug: RTV Placebo · Drug: FTC/TDF Placebo
Active comparator
ATV + RTV+ FTC/TDF
ATV + RTV + FTC/TDF + E/C/F/TDF placebo
Drug: ATV · Drug: RTV · Drug: FTC/TDF · Drug: E/C/F/TDF Placebo
Experimental
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.
Drug: E/C/F/TDF · Drug: ATV · Drug: RTV · Drug: FTC/TDF · Drug: E/C/F/TAF

Interventions

DrugE/C/F/TDF
150/150/200/300 mg FDC tablet administered orally with food once daily
Also known as: Stribild®
DrugATV
300 mg capsule administered orally with food once daily
Also known as: Reyataz®
DrugRTV
100 mg tablet administered orally with food once daily
Also known as: Norvir®
DrugFTC/TDF
200/300 mg tablet administered orally with food once daily
Also known as: Truvada®
DrugE/C/F/TDF Placebo
Tablet administered orally with food once daily
DrugATV Placebo
Tablet administered orally with food once daily
DrugRTV Placebo
Capsule administered orally with food once daily
DrugFTC/TDF Placebo
Tablet administered orally with food once daily
DrugE/C/F/TAF
150/150/200/10 mg FDC tablet administered orally with food once daily
Also known as: Genvoya®

What researchers measure

Primary outcomes

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.
Time frame: Week 48

Secondary outcomes

Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase
Time frame: Baseline; Week 48
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.
Time frame: Week 96
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.
Time frame: Open-Label Extension Week 48
Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase
Time frame: Baseline; Open-Label Extension Week 48

Results

Posted Mar 10, 2016

Limitations and caveats

There were no limitations affecting the analysis or results.

Participant flow

Participants were enrolled at study sites in North America, Europe, Dominican Republic, Thailand, and Uganda. The first participant was screened on 24 October 2012. The last study visit occurred on 06 September 2018.

Double-Blind Phase

Participant flow — Double-Blind Phase
Milestone	Double-Blind STB to Open-Label STB	Double-Blind ATV+RTV+TVD
Started	293	290
Completed	260	249
Not completed	33	41
Withdrew: Lost to follow-up	12	16
Withdrew: Adverse event	3	10
Withdrew: Withdrew consent	8	5
Withdrew: Non-compliance with study drug	4	5
Withdrew: Pregnancy	1	1
Withdrew: Protocol violation	1	0
Withdrew: Randomized but not treated	4	4

Open-Label Extension Phase

Participant flow — Open-Label Extension Phase
Milestone	Double-Blind STB to Open-Label STB	Double-Blind ATV+RTV+TVD to Open-Label GEN	Double-Blind ATV+RTV+TVD to Open-Label ATV+RTV+TVD
Started	246	159	53
Completed	231	148	48
Not completed	15	11	5
Withdrew: Lost to follow-up	6	2	2
Withdrew: Withdrew consent	4	4	1
Withdrew: Adverse event	3	0	1
Withdrew: Death	2	1	0
Withdrew: Non-compliance with study drug	0	1	0
Withdrew: Physician decision	0	2	0
Withdrew: Pregnancy	0	1	1

Outcome measures

PrimaryPercentage 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.

Time frame:: Week 48
Reported as:: Number · percentage of participants

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
percentage of participants	Double-Blind STB	Double-Blind ATV+RTV+TVD
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	87.2	80.8

Statistical analysis

Double-Blind STB vs Double-Blind ATV+RTV+TVD · Difference in proportions: 6.5 · 95.2% CI 0.4 to 12.6Difference in percentages of virologic success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel (MH) proportion.
Double-Blind STB vs Double-Blind ATV+RTV+TVD · Cochran-Mantel-Haenszel · p = 0.034 · Difference in proportions: 6.5 · 95.2% CI 0.4 to 12.6Difference in percentages of virologic success and its 95.2% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted MH proportion. If the lower bound of the CI was \> 0, superiority of STB over ATV+RTV+TVD was established.

SecondaryChange From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase

Time frame:: Baseline; Week 48
Reported as:: Mean · cells/μL

Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase
cells/μL	Double-Blind STB	Double-Blind ATV+RTV+TVD
Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase	221 ± 165.1	212 ± 176.8

SecondaryPercentage 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.

Time frame:: Week 96
Reported as:: Number · Percentage of participants

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
Percentage of participants	ALL STB
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	84.5 (79.7 to 88.6)

SecondaryPercentage 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.

Time frame:: Open-Label Extension Week 48
Reported as:: Number · Percentage of participants

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
Percentage of participants	Open-Label GEN	Open-Label ATV+RTV+TVD
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	94.3	86.8

SecondaryChange in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase

Time frame:: Baseline; Open-Label Extension Week 48
Reported as:: Mean · cells/uL

Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase
cells/uL	Open-Label STB	Open-Label GEN	Open-Label ATV + RTV + TVD
Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase	265 ± 190.4	35 ± 137.5	49 ± 204.8

Adverse events

Collected over First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Double-Blind: STB	—	25/289 (8.7%)	176/289 (60.9%)
Double-Blind: ATV+RTV+TVD	—	29/286 (10.1%)	194/286 (67.8%)
DB STB to OL STB	—	13/246 (5.3%)	118/246 (48%)
DB ATV+RTV+TVD to OL GEN	—	12/159 (7.5%)	68/159 (42.8%)
DB ATV+RTV+TVD to OL ATV+RTV+TVD	—	4/53 (7.5%)	20/53 (37.7%)

Most frequent serious events

Showing 10 of 79

Most frequent serious events
Event	Double-Blind: STB	Double-Blind: ATV+RTV+TVD	DB STB to OL STB	DB ATV+RTV+TVD to OL GEN	DB ATV+RTV+TVD to OL ATV+RTV+TVD
Abortion spontaneousPregnancy, puerperium and perinatal conditions	2/289	2/286	1/246	3/159	2/53
Abdominal painGastrointestinal disorders	0/289	1/286	1/246	0/159	1/53
Ectopic pregnancyPregnancy, puerperium and perinatal conditions	1/289	0/286	0/246	0/159	1/53
Ruptured ectopic pregnancyPregnancy, puerperium and perinatal conditions	0/289	0/286	0/246	0/159	1/53
Musculoskeletal painMusculoskeletal and connective tissue disorders	0/289	2/286	0/246	0/159	0/53
Acute kidney injuryRenal and urinary disorders	0/289	2/286	0/246	0/159	0/53
PneumoniaInfections and infestations	2/289	1/286	1/246	0/159	0/53
DepressionPsychiatric disorders	2/289	1/286	0/246	0/159	0/53
AsthmaRespiratory, thoracic and mediastinal disorders	2/289	0/286	0/246	0/159	0/53
Coronary artery occlusionCardiac disorders	0/289	0/286	0/246	1/159	0/53

Most frequent other events

Showing 10 of 22

Most frequent other events
Event	Double-Blind: STB	Double-Blind: ATV+RTV+TVD	DB STB to OL STB	DB ATV+RTV+TVD to OL GEN	DB ATV+RTV+TVD to OL ATV+RTV+TVD
Upper respiratory tract infectionInfections and infestations	50/289	45/286	36/246	23/159	10/53
HeadacheNervous system disorders	49/289	44/286	27/246	20/159	5/53
NauseaGastrointestinal disorders	43/289	41/286	6/246	7/159	2/53
Neuropathy peripheralNervous system disorders	21/289	20/286	12/246	10/159	7/53
Ocular icterusHepatobiliary disorders	1/289	34/286	0/246	0/159	0/53
MalariaInfections and infestations	34/289	25/286	14/246	8/159	1/53
JaundiceHepatobiliary disorders	1/289	30/286	0/246	0/159	1/53
VomitingGastrointestinal disorders	28/289	17/286	3/246	4/159	0/53
Back painMusculoskeletal and connective tissue disorders	20/289	17/286	13/246	14/159	1/53
Urinary tract infectionInfections and infestations	22/289	23/286	15/246	9/159	0/53

Baseline characteristics

Safety Analysis Set included participants who were randomized and received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)	Double-Blind STB to Open-Label STB	Double-Blind ATV+RTV+TVD to OL GEN or OL ATV+ RTV+TVD	Total
Mean	36 ± 10.1	36 ± 9.7	36 ± 9.9

Sex: Female, Male
Sex: Female, Male(Participants)	Double-Blind STB to Open-Label STB	Double-Blind ATV+RTV+TVD to OL GEN or OL ATV+ RTV+TVD	Total
Female	289	286	575
Male	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Double-Blind STB to Open-Label STB	Double-Blind ATV+RTV+TVD to OL GEN or OL ATV+ RTV+TVD	Total
Asian	9	17	26
Black	143	133	276
Native Hawaiian or Pacific Islander	0	1	1
White	128	119	247
Other	9	15	24
Not Permitted	0	1	1

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Double-Blind STB to Open-Label STB	Double-Blind ATV+RTV+TVD to OL GEN or OL ATV+ RTV+TVD	Total
Hispanic or Latino	20	24	44
Not Hispanic or Latino	269	262	531
Not Permitted	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Double-Blind STB to Open-Label STB	Double-Blind ATV+RTV+TVD to OL GEN or OL ATV+ RTV+TVD	Total
Russia	101	91	192
United States	59	60	119
United Kingdom	8	12	20
Thailand	9	15	24
Portugal	8	13	21
Belgium	3	5	8
Dominican Republic	6	13	19
Italy	4	1	5
Mexico	3	1	4
Uganda	87	74	161
France	1	1	2

CD4 Cell Count
CD4 Cell Count(cells/µL)	Double-Blind STB to Open-Label STB	Double-Blind ATV+RTV+TVD to OL GEN or OL ATV+ RTV+TVD	Total
Mean	376 ± 199.6	385 ± 210.2	381 ± 204.8

HIV-1 RNA Category
HIV-1 RNA Category(Participants)	Double-Blind STB to Open-Label STB	Double-Blind ATV+RTV+TVD to OL GEN or OL ATV+ RTV+TVD	Total
≤ 100,000 copies/mL	220	214	434
> 100,000 to ≤400,000 copies/mL	44	50	94
> 400,000 copies/mL	25	22	47

Study locations

99 sites

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
Whitman-Walker Health
Washington, District of Columbia 20009, United States
George Washington University Medical Faculty Associates
Washington, District of Columbia 20037, United States
Midway Immunology and Research Center
Fort Pierce, Florida 34982, United States
University of Miami
Miami, Florida 33136, United States
Orlando Immunology Center
Orlando, Florida 32803, United States
IDOCF/ValuhealthMD
Orlando, Florida 32806, 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
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
Saint Michael's Medical Center
Newark, New Jersey 07102, United States
New Jersey Medical School
Newark, New Jersey 07103, 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
Thomas Jefferson University
Philadelphia, Pennsylvania 19107, United States
Temple University Hospital- Internal General Medicine
Philadelphia, Pennsylvania 19140, 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
Institute of Tropical Medicine
Antwerp, 2000, Belgium
Saint-Pierre University Hospital
Brussels, 1000, Belgium
Hôpitaux IRIS SUD
Brussels, 1050, Belgium
Instituto Dominicano de Estudio Virologicos - IDEV
Santo Domingo, 10514, Dominican Republic
Salvador B Gautier Hospital, Infectious Diseases Department
Santo Domingo, 10514, Dominican Republic
Hôpital Bichat Claude Bernard
Paris, 75018, France
Hopital Tenon
Paris, 75020, 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 Dr Juan I Menchaca
Guadalajara, Jalisco 44340, Mexico
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 Dos Capuchos, Centro Hospitalar De Lisboa Central
Lisboa, 1200-110, Portugal
Hospital de Santa Maria - Serviço de Doenças Infecciosas
Lisboa, 1649-035, Portugal
centro Hospitalar S. João
Porto, 4200-319, Portugal
Centro Hospitalar do Porto - Hospital Joaquim Urbano
Porto, 4369-004, 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
Infectious Hospital 2
Moscow, 105275, Russian Federation
State Healthcare Institution Infectious Clinical Hospital #2 of Moscow City Healthcare Department
Moscow, 105275, Russian Federation
GKUZ MO "Center for Prevention and Treatment of AIDS and Infectious Diseases" (Moscow Regional AIDS Center)
Moscow, 129110, 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
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
Saint-Petersburg GUZ "Clinical Infectious Hospital named after S.P.Botkin"
Saint-Petersburg, 191167, Russian Federation
Federal State Budgetary Institution "Republic Clinical Infectious Hospital"
Saint-Petersburg, 196645, 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
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, 10330, Thailand
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, 10400, Thailand
Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital
Bangkok, 10700, Thailand
Chiang Mai University
Chiang Mai, 50200, Thailand
Bamrasnaradura lnfectious Disease Institute
Nonthaburi, 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
Royal Free London NHS Foundation Trust
London, NW32QG, United Kingdom
Queen Elizabeth Hospital, South London Healthcare NHS Trust
London, SE18 4QH, United Kingdom
Kings College London
London, SE59RJ, United Kingdom
St George's Healthcare NHS Trust
London, SW17 0QT, United Kingdom
Imperial College Healthcare NHS Trust
London, W21NY, United Kingdom
Mortimer Market Centre and Central and North West London NHS Foundation Trust
London, WC1E 6JB, United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, RG1 5LE, United Kingdom

References and documents

Publications

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. PubMed 27562742 ↗
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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01705574
Lead sponsor: Gilead Sciences
Responsible party: Sponsor
First posted: Oct 12, 2012
Start date: Oct 24, 2012
Primary completion: Feb 9, 2015
Completion: Sep 6, 2018
Results posted: Mar 10, 2016
Last update: Sep 20, 2019

Study contacts

Gilead Study Director

study director · Gilead Sciences

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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