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A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00824369
First received: January 15, 2009
Last updated: July 31, 2014
Last verified: July 2014
Results First Received: January 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: HIV-1
Intervention: Drug: No drug will be administered

  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 from two parent studies (A5271015 and A5271022) were included if they discontinued treatment due to virologic failure or other reasons. Participants from 6 countries were enrolled into the A5271015 study and the A5271022 study enrolled participants from 8 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twelve and 40 participants who had received: LRV 500 mg QD, LRV 750 mg QD or efavirenz 600 mg QD (in A5271015);or LRV 750 mg QD, LRV 1000 mg QD or etravirine 200 mg BID (in A5271022) were enrolled and treated with open-label antiretrovirals excluding LRV. Data summaries were provided by the randomized treatment groups of the parent protocol.

Reporting Groups
  Description
Participants From A5271015 - Lersivirine 500 mg Arm Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
Participants From A5271015 - Lersivirine 750 mg Arm Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
Participants From A5271015 - Efavirenz 600 mg Arm Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
Participants From A5271022 - Lersivirine 750 mg Arm Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
Participants From A5271022 - Lersivirine 1000 mg Arm Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
Participants From A5271022 - Etravirine 200 mg Arm Participants who had received etravirine 200 mg twice daily in A5271022 parent study

Participant Flow:   Overall Study
    Participants From A5271015 - Lersivirine 500 mg Arm     Participants From A5271015 - Lersivirine 750 mg Arm     Participants From A5271015 - Efavirenz 600 mg Arm     Participants From A5271022 - Lersivirine 750 mg Arm     Participants From A5271022 - Lersivirine 1000 mg Arm     Participants From A5271022 - Etravirine 200 mg Arm  
STARTED     5     4     3     11     12     17  
COMPLETED     4     4     2     9     11     16  
NOT COMPLETED     1     0     1     2     1     1  
Nolonger willing to participate in study                 1                 0                 1                 2                 0                 1  
Lost to Follow-up                 0                 0                 0                 0                 1                 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.
No text entered.

Reporting Groups
  Description
Participants From A5271015 - Lersivirine 500 mg Arm Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
Participants From A5271015 - Lersivirine 750 mg Arm Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
Participants From A5271015 - Efavirenz 600 mg Arm Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
Participants From A5271022 - Lersivirine 750 mg Arm Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
Participants From A5271022 - Lersivirine 1000 mg Arm Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
Participants From A5271022 - Etravirine 200 mg Arm Participants who had received etravirine 200 mg twice daily in A5271022 parent study
Total Total of all reporting groups

Baseline Measures
    Participants From A5271015 - Lersivirine 500 mg Arm     Participants From A5271015 - Lersivirine 750 mg Arm     Participants From A5271015 - Efavirenz 600 mg Arm     Participants From A5271022 - Lersivirine 750 mg Arm     Participants From A5271022 - Lersivirine 1000 mg Arm     Participants From A5271022 - Etravirine 200 mg Arm     Total  
Number of Participants  
[units: participants]
  5     4     3     11     12     17     52  
Age, Customized  
[units: years]
Mean ± Standard Deviation
             
Participants from A5271015     33.8  ± 6.1     31.5  ± 1.7     38.3  ± 3.2     NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   34.2  ± 4.8  
Participants from A5271022     NA  ± NA [2]   NA  ± NA [2]   NA  ± NA [2]   42.7  ± 9.1     39.1  ± 9.0     41.6  ± 9.4     41.2  ± 9.1  
Gender  
[units: Number¬†of¬†participants]
             
Female     2     2     1     5     7     11     28  
Male     3     2     2     6     5     6     24  
[1] This arm belongs to the study A5271022 and not A5271015.
[2] This arm belongs to the study A5271015 and not A5271022.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events   [ Time Frame: End of Study visit or the Early Termination visit ]

2.  Secondary:   Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit   [ Time Frame: Baseline, Month 6, Month 12 and Last visit ]

3.  Secondary:   Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit   [ Time Frame: Baseline, Month 6, Month 12 and Last visit ]

4.  Secondary:   Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12   [ Time Frame: Baseline, Month 6 and Month 12 ]

5.  Secondary:   CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12   [ Time Frame: Baseline, Month 6 and Month 12 ]


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00824369     History of Changes
Other Study ID Numbers: A5271038
Study First Received: January 15, 2009
Results First Received: January 16, 2014
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration