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Acquired Immunodeficiency SyndromePhase 3WAVESNCT01705574

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 study testing E/C/F/TDF, ATV and RTV in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 99 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
E/C/F/TDF, ATV and RTV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
583 participants
Where
99 sitesin 12 countries
Study dates
24 Oct 2012to 6 Sep 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

99 sites in 12 countries.

99 sites in 12 countries

United States41 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18102

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • Emory HIV/AIDS Clinical Trials Unit

    Atlanta, Georgia, 30308

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • UT - Physicians

    Bellaire, Texas, 77401

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of North Carolina AIDS Clinical Trials Unit

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Wexner Medical Center at the Ohio State University

    Columbus, Ohio, 43210

  • AIDS Arms, Inc./Trinity Health & Wellness Center

    Dallas, Texas, 75208

  • North Texas Infectious Diseases Consultants, PA

    Dallas, Texas, 75208

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • New York Hospital Queens

    Flushing, New York, 01135

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • East Carolina University The Brody School of Medicine Div. of Infectious Diseases

    Greenville, North Carolina, 27834

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • University of Southern California AIDS Clinical Trials Group

    Los Angeles, California, 90033

  • University of Louisville

    Louisville, Kentucky, 40202

  • Mercer University Mercer Medicine

    Macon, Georgia, 31201

  • University of Miami

    Miami, Florida, 33136

  • LSUHSC HIV Out-Patient Clinic Research

    New Orleans, Louisiana, 70119

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • New Jersey Medical School

    Newark, New Jersey, 07103

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • IDOCF/ValuhealthMD

    Orlando, Florida, 32806

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital- Internal General Medicine

    Philadelphia, Pennsylvania, 19140

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • University of Rochester

    Rochester, New York, 14642

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • Chatham County Health Daprtment

    Savannah, Georgia, 31401

  • The Research Institute

    Springfield, Massachusetts, 01105

  • St. Joseph's Hospital Comprehensive Research Institute

    Tampa, Florida, 33614

  • Montefiore Medical Center

    The Bronx, New York, 10040

  • The University of Toledo Medical Center

    Toledo, Ohio, 43614

  • Whitman-Walker Health

    Washington D.C., District of Columbia, 20009

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33401

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Russia21 sites

  • Republic of Altay Center for Prevention and Control of AIDS and Infectious Diseases

    Barnaul, 656010

  • GUZ "Irkutsk Regional Center for Prevention and Control of AIDS and Infectious Diseases

    Irkutsk, 664043

  • Khabarovsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases

    Khabarovsk, 680031

  • "Infectious Diseases Center", LLC

    Koltsovo, 630559

  • State Budget Healthcare Institution "Clinical Centre for AIDS and Infectious Diseases Fight and Prevention" of Krasnodar regio Department for Healthcare

    Krasnodar, 350015

  • GUZ "Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases"

    Krasnoyarsk, 660049

  • GUZ "Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases"

    Lipetsk, 398043

  • Infectious Hospital 2

    Moscow, 105275

  • State Healthcare Institution Infectious Clinical Hospital #2 of Moscow City Healthcare Department

    Moscow, 105275

  • GKUZ MO "Center for Prevention and Treatment of AIDS and Infectious Diseases" (Moscow Regional AIDS Center)

    Moscow, 129110

  • State Budget Health Institution of Nizhniy Novgorod "Nizhniy Novgorod Regional Center of prophylaxis and treatment of AIDS and Infectious Diseases

    Nizhny Novgorod, 603950

  • Budgetary Medical Facility of the Orel Region "Orel Regional Center for Prevention and Control of AIDS and Infectious Diseases"

    Oryol, 302040

  • Perm Regional Center for Prevention and Control of AIDS and Infectious Diseases

    Perm, 614000

  • St.Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, In-patient Department

    Saint Petersburg, 190020

  • St.Petersburg GUZ "Center for Prevention and Control of AIDS and Infectious Diseases", Out-patient Department

    Saint Petersburg, 190103

  • Saint-Petersburg GUZ "Clinical Infectious Hospital named after S.P.Botkin"

    Saint Petersburg, 191167

  • Federal State Budgetary Institution "Republic Clinical Infectious Hospital"

    Saint Petersburg, 196645

  • Saratov Regional Centre for Treatment and Prevention of AIDS and Infectious Diseases

    Saratov, 410009

  • Volgograd Regional Center for Prevention and Control of AIDS and Infectious Diseases

    Volgograd, 400040

  • GUZ "Voronezh Regional Center for Prevention and Control of AIDS and Infectious Diseases"

    Voronezh, 394065

  • Sverdlovsk Regional Center for Prevention and control of AIDS and Infectious Diseases

    Yekaterinburg, 620102

Other trials in Russia

United Kingdom9 sites

  • Barts Healthe NHS Trust

    London, E11BB

  • Homerton University Hospital NHS Foundation Trust

    London, E96SR

  • Royal Free London NHS Foundation Trust

    London, NW32QG

  • Queen Elizabeth Hospital, South London Healthcare NHS Trust

    London, SE18 4QH

  • Kings College London

    London, SE59RJ

  • St George's Healthcare NHS Trust

    London, SW17 0QT

  • Imperial College Healthcare NHS Trust

    London, W21NY

  • Mortimer Market Centre and Central and North West London NHS Foundation Trust

    London, WC1E 6JB

  • Royal Berkshire NHS Foundation Trust

    Reading, RG1 5LE

Other trials in United Kingdom

Portugal6 sites

  • Hospital Fernando Fonseca

    Amadora, 2720-276

  • Hospital Dos Capuchos, Centro Hospitalar De Lisboa Central

    Lisbon, 1200-110

  • Hospital de Santa Maria - Serviço de Doenças Infecciosas

    Lisbon, 1649-035

  • centro Hospitalar S. João

    Porto, 4200-319

  • Centro Hospitalar do Porto - Hospital Joaquim Urbano

    Porto, 4369-004

  • Hospital de Santarém

    Santarém, 2005-177

Other trials in Portugal

Thailand5 sites

  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

    Bangkok, 10330

  • Faculty of Medicine Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

  • Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital

    Bangkok, 10700

  • Chiang Mai University

    Chiang Mai, 50200

  • Bamrasnaradura lnfectious Disease Institute

    Nonthaburi, 11000

Other trials in Thailand

France4 sites

  • Hôpital Bichat Claude Bernard

    Paris, 75018

  • Hopital Tenon

    Paris, 75020

  • Maladies Infectieuses Dpt

    Paris, 75651

  • Hopitaux Universitaires Strasbourg

    Strasbourg, 67091

Other trials in France

Belgium3 sites

  • Institute of Tropical Medicine

    Antwerp, 2000

  • Saint-Pierre University Hospital

    Brussels, 1000

  • Hôpitaux IRIS SUD

    Brussels, 1050

Other trials in Belgium

Italy3 sites

  • Department of Health Sciences - University of Milan - San Paolo Hospital

    Milan, 20142

  • Luigi Sacco Hospital, Milan

    Milan, 20157

  • Clinica Malattie Infettive, Azienda Ospedaliero Universitaria

    Modena, 41124

Other trials in Italy

Mexico3 sites

  • Hospital Civil de Guadalajara Dr Juan I Menchaca

    Guadalajara, Jalisco, 44340

  • Hospital Civil de Guadalajara

    Guadalajara, 44280

  • Intituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Mexico City, 14000

Other trials in Mexico

Dominican Republic2 sites

  • Instituto Dominicano de Estudio Virologicos - IDEV

    Santo Domingo, 10514

  • Salvador B Gautier Hospital, Infectious Diseases Department

    Santo Domingo, 10514

Other trials in Dominican Republic

Puerto Rico1 site

  • Maternal Infants Studies Center (CEMI)

    San Juan, 00936

Other trials in Puerto Rico

Uganda1 site

  • Joint Clinical Research Centre

    Kampala

Other trials in Uganda

About this study

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

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.

Being tested
E/C/F/TDF, ATV, RTV, FTC/TDF, E/C/F/TDF Placebo
Keywords
HIV-1, HIV, Treatment-Naive, Women, WAVES
Medical subject headings
Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E/C/F/TDFDrug

    Also called Stribild®

    150/150/200/300 mg FDC tablet administered orally with food once daily

  • ATVDrug

    Also called Reyataz®

    300 mg capsule administered orally with food once daily

  • RTVDrug

    Also called Norvir®

    100 mg tablet administered orally with food once daily

  • FTC/TDFDrug

    Also called Truvada®

    200/300 mg tablet administered orally with food once daily

  • E/C/F/TDF PlaceboDrug

    Tablet administered orally with food once daily

  • ATV PlaceboDrug

    Tablet administered orally with food once daily

  • RTV PlaceboDrug

    Capsule administered orally with food once daily

  • FTC/TDF PlaceboDrug

    Tablet administered orally with food once daily

  • E/C/F/TAFDrug

    Also called Genvoya®

    150/150/200/10 mg FDC tablet administered orally with food once daily

Study groups in NCT01705574
Study groupRoleWhat they receive
E/C/F/TDFExperimentalE/C/F/TDF + ATV placebo + RTV placebo + FTC/TDF placebo
Receives: Drug: E/C/F/TDF; Drug: ATV Placebo; Drug: RTV Placebo; Drug: FTC/TDF Placebo
ATV + RTV+ FTC/TDFActive comparatorATV + RTV + FTC/TDF + E/C/F/TDF placebo
Receives: Drug: ATV; Drug: RTV; Drug: FTC/TDF; Drug: E/C/F/TDF Placebo
Open-Label Extension PhaseExperimentalAfter 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.
Receives: Drug: E/C/F/TDF; Drug: ATV; Drug: RTV; Drug: FTC/TDF; Drug: E/C/F/TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 48

Secondary outcomes (4)

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

    Measured: Baseline; Week 48

  2. 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.

    Measured: Week 96

  3. 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.

    Measured: Open-Label Extension Week 48

  4. Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase

    Measured: Baseline; Open-Label Extension Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2012 (estimated)
  2. Study start24 Oct 2012
  3. Primary completion9 Feb 2015
  4. Study completion6 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
583 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01705574
Sponsor's protocol ID
GS-US-236-0128
Other IDs
2012-003708-11
Acronym
WAVES
Status last verified
Sep 2019
First submitted
10 Oct 2012
Last updated
20 Sep 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E/C/F/TDF, ATV and RTV in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 99 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Russia, United Kingdom, Portugal, Thailand and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01705574, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.

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