Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF 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:
NCT01533259
First received: February 2, 2012
Last updated: January 16, 2015
Last verified: January 2015
Results First Received: January 16, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Intervention: Drug: Stribild

  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 a total of 7 study sites in the United States. The first participant was screened on 31 January 2012. The last study visit occurred on 23 August 2013.

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

Reporting Groups
  Description
Stribild Switch from existing treatment regimen to Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regiment (STR) once daily for 48 weeks

Participant Flow:   Overall Study
    Stribild  
STARTED     48  
COMPLETED     48  
NOT COMPLETED     0  



  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 received at least one dose of study drug.

Reporting Groups
  Description
Stribild Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks

Baseline Measures
    Stribild  
Number of Participants  
[units: participants]
  48  
Age  
[units: years]
Mean ± Standard Deviation
  44  ± 8.6  
Gender  
[units: participants]
 
Female     2  
Male     46  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     10  
Not Hispanic or Latino     38  
Unknown or Not Reported     0  
Race/Ethnicity, Customized  
[units: participants]
 
White     40  
Black or African American     7  
Asian     1  
Baseline HIV-1 RNA Category  
[units: participants]
 
< 50 copies/mL     46  
50 to < 200 copies/mL     2  
CD4 Cell Count  
[units: cells/µL]
Mean ± Standard Deviation
  711  ± 265.9  
HIV Disease Status  
[units: participants]
 
Asymptomatic     45  
Symptomatic HIV Infection     1  
AIDS     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities   [ Time Frame: Up to 48 weeks plus 30 days ]

3.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48   [ Time Frame: Weeks 24 and 48 ]


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


No publications provided


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01533259     History of Changes
Other Study ID Numbers: GS-US-236-0123
Study First Received: February 2, 2012
Results First Received: January 16, 2015
Last Updated: January 16, 2015
Health Authority: United States: Food and Drug Administration