Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01475838
First received: November 17, 2011
Last updated: May 6, 2016
Last verified: May 2016
Results First Received: January 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Interventions: Drug: PI
Drug: RTV
Drug: FTC/TDF
Drug: Stribild

  Participant Flow
  Hide Participant Flow

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 and Europe. The first participant was screened on 18 November 2011. The last study visit occurred on 09 December 2014

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

Reporting Groups
  Description
Stribild Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
PI+RTV+FTC/TDF Participants stayed on their baseline treatment regimen consisting of a protease inhibitor (PI) (atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)) boosted with ritonavir (RTV) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.

Participant Flow for 2 periods

Period 1:   Randomized Phase
    Stribild   PI+RTV+FTC/TDF
STARTED   293   145 
COMPLETED   263   109 
NOT COMPLETED   30   36 
Randomized but Not Treated                0                5 
Adverse Event                6                1 
Pregnancy                0                1 
Investigators Discretion                1                2 
Withdrew Consent                10                14 
Lost to Follow-up                3                4 
Participant Noncompliance                1                5 
Protocol Violation                9                4 

Period 2:   Extension Phase
    Stribild   PI+RTV+FTC/TDF
STARTED   42   20 
COMPLETED   41   20 
NOT COMPLETED   1   0 
Participant Noncompliance                1                0 



  Baseline Characteristics
  Hide Baseline Characteristics

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 were randomized and received at least one dose of study medication.

Reporting Groups
  Description
Stribild Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
PI+RTV+FTC/TDF Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
Total Total of all reporting groups

Baseline Measures
   Stribild   PI+RTV+FTC/TDF   Total 
Overall Participants Analyzed 
[Units: Participants]
 293   140   433 
Age 
[Units: Years]
Mean (Standard Deviation)
 41  (9.7)   41  (8.9)   41  (9.4) 
Age, Customized 
[Units: Participants]
     
< 40 years   130   68   198 
≥ 40 to < 50 years   109   49   158 
≥ 50 years   54   23   77 
Gender 
[Units: Participants]
     
Female   43   19   62 
Male   250   121   371 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   2   1   3 
Asian   7   2   9 
Black or African Heritage   43   20   63 
White   234   113   347 
Other   5   2   7 
Not Permitted   2   2   4 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino   42   17   59 
Non-Hispanic/Latino   249   123   372 
Not Permitted   2   0   2 
Region of Enrollment 
[Units: Participants]
     
Portugal   12   7   19 
France   39   15   54 
United States   84   40   124 
Puerto Rico   3   2   5 
Canada   5   3   8 
Spain   28   21   49 
Belgium   6   2   8 
Austria   11   4   15 
Germany   36   21   57 
United Kingdom   13   1   14 
Switzerland   12   8   20 
Italy   44   16   60 
HIV-1 RNA Category 
[Units: Participants]
     
< 50 copies/mL   291   137   428 
50 to < 200 copies/mL   2   2   4 
200 to < 400 copies/mL   0   0   0 
≥ 400 copies/mL   0   1   1 
CD4+ Cell Count 
[Units: cells/µL]
Mean (Standard Deviation)
 604  (274.6)   624  (269.9)   610  (272.9) 
CD4+ Cell Count Category 
[Units: Participants]
     
≤ 50 cells/µL   0   0   0 
51 to ≤ 200 cells/µL   9   6   15 
201 to ≤ 350 cells/µL   37   14   51 
351 to ≤ 500 cells/µL   69   26   95 
> 500 cells/µL   178   94   272 
HIV Disease Status 
[Units: Participants]
     
Asymptomatic   214   105   319 
Symptomatic HIV Infections   38   17   55 
AIDS   41   18   59 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96   [ Time Frame: Week 96 ]

3.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 48   [ Time Frame: Baseline; Week 48 ]

4.  Secondary:   Change From Baseline in CD4+ Cell Count at Week 96   [ Time Frame: Baseline; Week 96 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01475838     History of Changes
Other Study ID Numbers: GS-US-236-0115
2011-004483-30 ( EudraCT Number )
Study First Received: November 17, 2011
Results First Received: January 8, 2015
Last Updated: May 6, 2016
Health Authority: United States: Food and Drug Administration