This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01705574
First received: October 10, 2012
Last updated: August 15, 2017
Last verified: August 2017
  Purpose

This study will evaluate the safety, efficacy, and tolerability of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) fixed-dose combination (FDC) versus ritonavir (RTV)-boosted atazanavir (ATV) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.

This study will consist of two phases: Double-Blinded Treatment Phase (48 weeks) and Open-Label Extension (OLE) Phase (48 weeks).

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 OLE Phase.


Condition Intervention Phase
Acquired Immunodeficiency Syndrome HIV Infections Drug: E/C/F/TDF Drug: RTV Drug: ATV Drug: FTC/TDF Drug: E/C/F/TDF Placebo Drug: RTV Placebo Drug: ATV Placebo Drug: FTC/TDF Placebo Drug: E/C/F/TAF Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase [ Time Frame: Week 48 ]
    The snapshot algorithm was used which defines a patient'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 [ Time Frame: Baseline; Week 48 ]
  • Percentage of Participants Receiving Open-Label E/C/F/TDF With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open- Label Extension Phase [ Time Frame: Open-Label Extension Week 48 ]
    The snapshot algorithm was used which defines a patient'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 E/C/F/TDF or ATV+RTV+FTC/TDF With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase [ 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 ]

Enrollment: 583
Actual Study Start Date: October 24, 2012
Estimated Study Completion Date: June 2018
Primary Completion Date: February 11, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E/C/F/TDF
E/C/F/TDF + ATV placebo + RTV placebo + FTC/TDF placebo
Drug: E/C/F/TDF
E/C/F/TDF (150/150/200/300 mg) FDC tablet administered orally with food once daily
Other Name: Stribild®
Drug: RTV Placebo
RTV placebo tablet administered orally with food once daily
Drug: ATV Placebo
ATV placebo capsule administered orally with food once daily
Drug: FTC/TDF Placebo
FTC/TDF placebo tablet administered orally with food once daily
Active Comparator: ATV+RTV+FTC/TDF
ATV+RTV+FTC/TDF + E/C/F/TDF placebo
Drug: RTV
RTV 100 mg tablet administered orally with food once daily
Other Name: Norvir®
Drug: ATV
ATV 300 mg capsule administered orally with food once daily
Other Name: Reyataz®
Drug: FTC/TDF
FTC/TDF (200/300 mg) tablet administered orally with food once daily
Other Name: Truvada®
Drug: E/C/F/TDF Placebo
E/C/F/TDF placebo tablet administered orally with food once daily
Experimental: Open-Label Extension
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 rerandomized to receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or ATV+RTV+FTC/TDF.
Drug: E/C/F/TDF
E/C/F/TDF (150/150/200/300 mg) FDC tablet administered orally with food once daily
Other Name: Stribild®
Drug: RTV
RTV 100 mg tablet administered orally with food once daily
Other Name: Norvir®
Drug: ATV
ATV 300 mg capsule administered orally with food once daily
Other Name: Reyataz®
Drug: FTC/TDF
FTC/TDF (200/300 mg) tablet administered orally with food once daily
Other Name: Truvada®
Drug: E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally with food once daily
Other Name: Genvoya®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705574

  Show 99 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01705574     History of Changes
Other Study ID Numbers: GS-US-236-0128
2012-003708-11 ( EudraCT Number )
Study First Received: October 10, 2012
Results First Received: February 11, 2016
Last Updated: August 15, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
HIV-1
HIV
Treatment-Naive
Women
WAVES

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Tenofovir
Cobicistat
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 20, 2017