A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01254656
First received: December 3, 2010
Last updated: May 27, 2014
Last verified: January 2014
Results First Received: January 21, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1
Interventions: Drug: lersivirine
Drug: efavirenz
Drug: etravirine

  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 who had completed 96 weeks of treatment with lersivirine in the A5271015 parent study were enrolled in this extension study. One participant from a second parent study (A5271022) was initially enrolled in Study A5271037, but later discontinued from A5271037.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were required to have plasma HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 84 of the parent protocol. Of 108 participants screened in the parent protocol A5271015, 47, 43, and 18 participants from the lersivirine 500 mg, lersivirine 750 mg, and efavirenz 600 mg groups, respectively, were enrolled in Study A5271037.

Reporting Groups
  Description
Lersivirine (LRV) 500 mg Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
LRV 750 mg Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Efavirenz (EFV) 600 mg Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD

Participant Flow:   Overall Study
    Lersivirine (LRV) 500 mg     LRV 750 mg     Efavirenz (EFV) 600 mg  
STARTED     47     43     18  
Treated     47     43     18  
COMPLETED     0     0     0  
NOT COMPLETED     47     43     18  
Discontinued due to termination of study                 40                 39                 13  
Lack of Efficacy                 3                 0                 0  
Lost to Follow-up                 1                 0                 2  
Withdrawal by Subject                 2                 2                 1  
Pregnancy                 0                 0                 2  
Adverse Event                 1                 1                 0  
Death                 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
Lersivirine (LRV) 500 mg Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
LRV 750 mg Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Efavirenz (EFV) 600 mg Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Total Total of all reporting groups

Baseline Measures
    Lersivirine (LRV) 500 mg     LRV 750 mg     Efavirenz (EFV) 600 mg     Total  
Number of Participants  
[units: participants]
  47     43     18     108  
Age  
[units: Years]
Mean ± Standard Deviation
  36.6  ± 8.4     35.8  ± 8.7     38.5  ± 7.8     36.6  ± 8.4  
Age, Customized  
[units: Participants]
       
< 18 Years     0     0     0     0  
18 - 44 Years     41     37     14     92  
45 - 64 Years     6     6     4     16  
>= 65 Years     0     0     0     0  
Gender  
[units: Participants]
       
Female     10     11     8     29  
Male     37     32     10     79  



  Outcome Measures
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1.  Primary:   Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV‑1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol   [ Time Frame: 144 Weeks from Day 1 of the parent protocol ]

2.  Secondary:   Number of Participants With Plasma HIV‑1 RNA Level <50 Copies/mL up to Week 208   [ Time Frame: Up to Week 208 ]

3.  Secondary:   Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol   [ Time Frame: 144 Weeks from Day 1 of the parent protocol ]

4.  Secondary:   Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol   [ Time Frame: 144 Weeks from Day 1 of the parent protocol ]

5.  Secondary:   Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol   [ Time Frame: 192 Weeks from Day 1 of the parent protocol ]

6.  Secondary:   Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol   [ Time Frame: 192 Weeks from Day 1 of the parent protocol ]

7.  Secondary:   Virology Analysis Participant Accountability From Week 96 Through Study Termination   [ Time Frame: Week 96 through study termination ]


  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
The study was terminated on 29 Jan 13 due to termination of lersivirine development program. All participants were enrolled from study A5271015 except one from A5271022. Above summarized outcome measures included participants enrolled from A5271015.


  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: NCT01254656     History of Changes
Other Study ID Numbers: A5271037
Study First Received: December 3, 2010
Results First Received: January 21, 2014
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration