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 (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 19, 2014
Last verified: August 2014

October 10, 2012
August 19, 2014
October 2012
March 2015   (final data collection date for primary outcome measure)
The proportion of subjects with HIV 1 RNA < 50 copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
The primary efficacy endpoint is the proportion of subjects with HIV 1 RNA <50 copies/mL at Week 48
The proportion of subjects with HIV 1 RNA <50 copies/mL at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
The primary efficacy endpoint is the proportion of subjects with HIV 1 RNA <50 copies/mL at Week 48
Complete list of historical versions of study NCT01705574 on ClinicalTrials.gov Archive Site
To evaluate the change in CD4+ cell count at Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
The change from baseline in CD4+ cell count at Week 48
Same as current
Not Provided
Not Provided
 
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 (WAVES)
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

This double-blind, randomized, multicenter, active-controlled study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate single-tablet regiment versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV-1 infected, antiretroviral treatment-naive adult women as determined by the achievement of HIV 1 RNA < 50 copies/mL at Week 48 (end of the double-blind period).

Subjects initially randomized to the EVG/COBI/FTC/TDF arm will have the option to continue open-label EVG/COBI/FTC/TDF STR (after Week 60) for an additional 48 weeks during an open-label extension period. Subjects initially randomized to the RTV+ATV+FTC/TDF arm will have the option to be rerandomized in a 1:3 ratio to continue treatment with RTV+ATV+FTC/TDF or switch to EVG/COBI/FTC/TAF STR (after Week 60) for an additional 48 weeks during an open-label extension period.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Drug: EVG/COBI/FTC/TDF
    Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen administered orally with food once daily
  • Drug: RTV
    Ritonavir 100 mg tablet administered orally with food once daily
    Other Name: Norvir®
  • Drug: ATV
    Atazanavir (ATV) 300 mg capsule administered orally with food once daily
    Other Name: Reyataz®
  • Drug: FTC/TDF
    FTC 200 mg/TDF 300 mg tablet administered orally with food once daily
    Other Name: Truvada®
  • Drug: EVG/COBI/FTC/TDF Placebo
    Placebo to match EVG/COBI/FTC/TDF administered with food orally once daily
  • Drug: RTV Placebo
    Placebo to match RTV administered orally with food once daily
  • Drug: ATV Placebo
    Placebo to match ATV administered orally with food once daily
  • Drug: FTC/TDF Placebo
    Placebo to match FTC/TDF administered orally with food once daily
  • Experimental: EVG/COBI/FTC/TDF
    EVG 150 mg/COBI 150mg/FTC 200 mg/TDF 300 mg STR plus placebos to match RTV, ATV, and FTC/TDF once daily
    Interventions:
    • Drug: EVG/COBI/FTC/TDF
    • Drug: RTV Placebo
    • Drug: ATV Placebo
    • Drug: FTC/TDF Placebo
  • Active Comparator: RTV+ATV+FTC/TDF
    RTV 100 mg plus ATV 300 mg plus FTC 200 mg/TDF 300 mg plus placebo to match EVG/COBI/FTC/TDF once daily
    Interventions:
    • Drug: RTV
    • Drug: ATV
    • Drug: FTC/TDF
    • Drug: EVG/COBI/FTC/TDF Placebo
  • Experimental: EVG/COBI/FTC/TDF Open Label Switch
    Participants randomized to the RTV+ATV+FTC/TDF arm switched to receive EVG/COBI/FTC/TDF in the open-label phase
    Interventions:
    • Drug: EVG/COBI/FTC/TDF
    • Drug: RTV
    • Drug: ATV
    • Drug: FTC/TDF
    • Drug: EVG/COBI/FTC/TDF Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
510
March 2016
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female (at birth), age ≥ 18 years
  • Ability to understand and sign a written informed consent form
  • Plasma HIV-1 RNA levels ≥500 copies/mL
  • No prior use of any approved or investigational antiretroviral drug for any length of time
  • Screening genotype report must show sensitivity to emtricitabine (FTC), tenofovir disoproxil fumarate (TDF) and atazanavir boosted with ritonavir (ATV/r)
  • Normal ECG
  • Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula
  • Hepatic transaminases ≤ 5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL
  • Adequate hematologic function
  • Serum amylase ≤ 5 x ULN
  • Women of childbearing potential must agree to utilize protocol recommended contraception methods or be non-heterosexually active, or practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug
  • Women who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.

Exclusion Criteria:

  • A new AIDS defining condition diagnosed within the 30 days
  • Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study
  • Subjects 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 subject 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 subject unsuitable for the study or unable to comply with the dosing requirements
  • Subjects receiving ongoing therapy with any disallowed medications, including drugs not to be used with EVG, COBI, FTC, TDF, ATV, RTV; or subjects with any known allergies to the excipients of EVG/COBI/FTC/TDF STR, Truvada® tablets, atazanavir capsules or ritonavir tablets
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Dominican Republic,   France,   Italy,   Mexico,   Portugal,   Puerto Rico,   Russian Federation,   Thailand,   Uganda,   United Kingdom
 
NCT01705574
GS-US-236-0128, 2012-003708-11
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Huyen Cao, MD Gilead Sciences
Gilead Sciences
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP