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: February 11, 2016
Last verified: February 2016
Results First Received: February 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Interventions: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Week 48 study visit occurred on 11 February 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
810 participants were screened.

Reporting Groups
  Description
E/C/F/TDF Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) (150/150/200/300 mg) fixed-dose combination (FDC) + atazanavir (ATV) placebo + ritonavir (RTV) placebo + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily for 48 weeks
ATV+RTV+FTC/TDF Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (Truvada®; 200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks

Participant Flow:   Overall Study
    E/C/F/TDF     ATV+RTV+FTC/TDF  
STARTED     293     290  
COMPLETED     126     127  
NOT COMPLETED     167     163  
Randomized but Not Treated                 4                 4  
Adverse Event                 3                 9  
Pregnancy                 1                 1  
Non-Compliance with Study Drug                 4                 4  
Protocol Violation                 1                 0  
Withdrew Consent                 8                 5  
Lost to Follow-up                 11                 15  
Still on Study                 135                 125  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Analysis Set: participants who were randomized and received at least one dose of study drug.

Reporting Groups
  Description
E/C/F/TDF Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
ATV+RTV+FTC/TDF Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
Total Total of all reporting groups

Baseline Measures
    E/C/F/TDF     ATV+RTV+FTC/TDF     Total  
Number of Participants  
[units: participants]
  289     286     575  
Age  
[units: years]
Mean (Standard Deviation)
  36  (10.1)     36  (9.7)     36  (9.9)  
Gender  
[units: participants]
     
Female     289     286     575  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
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  
[units: participants]
     
Hispanic or Latino     20     24     44  
Not Hispanic or Latino     269     262     531  
Region of Enrollment  
[units: participants]
     
Russian Federation     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  
HIV-1 RNA  
[units: log10 copies/mL]
Mean (Standard Deviation)
  4.51  (0.724)     4.52  (0.781)     4.51  (0.753)  
HIV-1 RNA Category  
[units: participants]
     
≤ 100,000     220     214     434  
> 100,000 to ≤400,000     44     50     94  
> 400,000     25     22     47  
CD4 Cell Count  
[units: cells/µL]
Mean (Standard Deviation)
  376  (199.6)     385  (210.2)     381  (204.8)  



  Outcome Measures
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1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase   [ Time Frame: Week 48 ]

2.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase   [ Time Frame: Baseline; Week 48 ]

3.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase   [ Time Frame: Baseline; Open-Label Extension Week 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were no limitations affecting the analysis or results.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
e-mail: ClinicalTrialDisclosures@gilead.com



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: February 11, 2016
Health Authority: United States: Food and Drug Administration