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Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00445146
First received: February 28, 2007
Last updated: March 23, 2016
Last verified: March 2016
Results First Received: March 23, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: EVG
Drug: RTV
Drug: ARV regimen

  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 the United States and Puerto Rico. The first participant was screened on 26 February 2007. The last study visit occurred on 24 March 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants must have been enrolled in other Gilead-sponsored studies of elvitegravir (EVG) + ritonavir (RTV) to be eligible to receive continued access to EVG+RTV in this study.

Reporting Groups
  Description
EVG+RTV

Elvitegravir (EVG) 85 or 150 mg tablet boosted with ritonavir (RTV; r/) 100 mg capsule once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.

Some participants may have received EVG 300 mg during the course of protocol amendment 2.


Participant Flow:   Overall Study
    EVG+RTV  
STARTED     192  
COMPLETED     73  
NOT COMPLETED     119  
Withdrew Consent                 29  
Lack of Efficacy                 28  
Investigator’s Discretion                 22  
Adverse Event                 13  
Lost to Follow-up                 13  
Death                 9  
Protocol Violation                 4  
Pregnancy                 1  



  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: enrolled participants who received at least 1 dose of EVG

Reporting Groups
  Description
EVG+RTV EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study. Some participants may have received EVG 300 mg during the course of protocol amendment 2.

Baseline Measures
    EVG+RTV  
Number of Participants  
[units: participants]
  192  
Age  
[units: years]
Mean (Standard Deviation)
  45  (9.2)  
Gender  
[units: participants]
 
Female     19  
Male     173  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     39  
Not Hispanic or Latino     153  
Unknown or Not Reported     0  
Race/Ethnicity, Customized  
[units: participants]
 
White     139  
Black or African American     48  
Native Hawaiian or Other Pacific Islander     1  
Other     4  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event   [ Time Frame: Up to Week 408 plus 30 days ]

2.  Secondary:   Percentage of Participants Experiencing Treatment-Emergent Adverse Events   [ Time Frame: Up to Week 408 plus 30 days ]

3.  Secondary:   Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality   [ Time Frame: Up to Week 408 plus 30 days ]

4.  Secondary:   Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality   [ Time Frame: Up to Week 408 plus 30 days ]

5.  Secondary:   Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384   [ Time Frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 ]

6.  Secondary:   Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384   [ Time Frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 ]

7.  Secondary:   White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384   [ Time Frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 ]

8.  Secondary:   Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384   [ Time Frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 ]

9.  Secondary:   Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384   [ Time Frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 ]

10.  Secondary:   Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384   [ Time Frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 ]

11.  Secondary:   Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384   [ Time Frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 ]

12.  Secondary:   HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384   [ Time Frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 ]

13.  Secondary:   Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384   [ Time Frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 ]

14.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384   [ Time Frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 ]

15.  Secondary:   CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384   [ Time Frame: Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 ]

16.  Secondary:   Incidence of Mortality   [ Time Frame: Up to Week 408 plus 30 days ]


  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
e-mail: ClinicalTrialDisclosures@Gilead.com



Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00445146     History of Changes
Other Study ID Numbers: GS-US-183-0130
Study First Received: February 28, 2007
Results First Received: March 23, 2016
Last Updated: March 23, 2016
Health Authority: United States: Food and Drug Administration