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: March 20, 2015
Last verified: March 2015

October 10, 2012
March 20, 2015
October 2012
February 2015   (final data collection date for primary outcome measure)
The proportion of participants with HIV 1 RNA < 50 copies/mL at Week 48 of the double-blind phase as defined by the FDA snapshot analysis [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
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
  • Change from baseline in CD4+ cell count at Week 48 of the double-blind phase [ Time Frame: Baseline; Week 48 ] [ Designated as safety issue: No ]
  • Proportion of participants receiving open-label EVG/COBI/FTC/TDF with HIV-1 RNA < 50 copies/mL (by FDA snapshot) at Week 48 of the OLE [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Proportion of participants receiving EVG/COBI/FTC/TAF or RTV+ATV+FTC/TDF with HIV-RNA <50 copies/mL (by FDA snapshot) at Week 48 of the OLE [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Change in CD4+ cell count at Week 48 of the OLE [ Time Frame: Baseline; Week 48 ] [ Designated as safety issue: No ]
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
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 study will evaluate the safety, efficacy, and tolerability of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regiment (STR) versus ritonavir (RTV)-boosted atazanavir (ATV) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women. This study will consist of two phases: Double-Blinded Treatment Phase (60 weeks) and Open Label Extension (OLE) Phase (48 weeks). Participants who are virologically suppressed at Week 48 during the Double-Blinded Treatment Phase will have the option to enter the OLE Phase. Participants randomized to the EVG/COBI/FTC/TDF arm in the Double-Blinded Treatment Phase will continue on open-label EVG/COBI/FTC/TDF STR while participants randomized to the RTV+ATV+FTC/TDF arm will be rerandomized in a 3:1 ratio to receive either open label elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) STR or RTV+ATV+FTC/TDF.

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
    Other Name: Stribild®
  • Drug: RTV
    Ritonavir (RTV) 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: Placebo to match EVG/COBI/FTC/TDF
    Placebo to match EVG/COBI/FTC/TDF administered orally with food once daily
  • Drug: Placebo to match RTV
    Placebo to match RTV administered orally with food once daily
  • Drug: Placebo to match ATV
    Placebo to match ATV administered orally with food once daily
  • Drug: Placebo to match FTC/TDF
    Placebo to match FTC/TDF administered orally with food once daily
  • Drug: EVG/COBI/FTC/TAF
    Elvitegravir (EVG) 150 mg/cobicistat (COBI) 200 mg/emtricitabine (FTC) 200 mg/tenofovir alafenamide (TAF) 10 mg single-tablet regimen administered orally with food once daily
  • Experimental: EVG/COBI/FTC/TDF
    EVG/COBI/FTC/TDF + placebo to match RTV + placebo to match ATV + placebo to match FTC/TDF
    Interventions:
    • Drug: EVG/COBI/FTC/TDF
    • Drug: Placebo to match RTV
    • Drug: Placebo to match ATV
    • Drug: Placebo to match FTC/TDF
  • Active Comparator: RTV+ATV+FTC/TDF
    RTV+ATV+FTC/TDF + placebo to match EVG/COBI/FTC/TDF
    Interventions:
    • Drug: RTV
    • Drug: ATV
    • Drug: FTC/TDF
    • Drug: Placebo to match EVG/COBI/FTC/TDF
  • Experimental: Open Label Extension
    Participants randomized to the EVG/COBI/FTC/TDF arm will continue to receive open-label EVG/COBI/FTC/TDF and participants randomized to the RTV+ATV+FTC/TDF arm will be rerandomized to receive EVG/COBI/FTC/TAF or RTV+ATV+FTC/TDF.
    Interventions:
    • Drug: EVG/COBI/FTC/TDF
    • Drug: RTV
    • Drug: ATV
    • Drug: FTC/TDF
    • Drug: EVG/COBI/FTC/TAF
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
583
March 2016
February 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
  • 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 EVG, COBI, FTC, TDF, ATV, RTV; or females 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
March 2015

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