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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

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ClinicalTrials.gov Identifier: NCT01254656
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : December 6, 2010
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 3, 2010
First Posted Date  ICMJE December 6, 2010
Results First Submitted Date  ICMJE January 21, 2014
Results First Posted Date  ICMJE June 9, 2014
Last Update Posted Date June 9, 2014
Study Start Date  ICMJE February 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
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 ]
Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at 48 weeks i.e. 144 weeks from Day 1 of the parent protocol. Roche Amplicor HIV-1 Monitor assay was used to measure the HIV-1 RNA level.
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2010)
  • Safety and tolerability of lersivirine as measured by adverse event reports and safety laboratory tests. [ Time Frame: 240 weeks ]
  • The percentage of subjects with HIV-1 RNA level <50 copies/mL at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol). [ Time Frame: 48 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
  • Number of Participants With Plasma HIV-1 RNA Level <50 Copies/mL up to Week 208 [ Time Frame: Up to Week 208 ]
    Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at last visit. Abbott RealTime HIV-1 assay was used to measure the HIV-1 RNA level.
  • 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 ]
    Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)
  • 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 ]
    Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)
  • 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 ]
    Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.
  • 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 ]
    Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.
  • Virology Analysis Participant Accountability From Week 96 Through Study Termination [ Time Frame: Week 96 through study termination ]
    Virology analysis included virus susceptibility (phenotype and genotype)to a standard panel of approved antiretrovirals as determined by the Monogram Biosciences PhenoSense GT assay. Below analysis table included the following parameters: 1. "protocol-defined treatment failure" was defined as an increase in HIV-1 RNA to detectable levels (≥50 copies/mL) on 2 consecutive measurements, the second measurement taken no more than 14 days after the first measurement); 2. "Treatment failure": treatment failure (both virologic and non-virologic) was defined as a subject who met the protocol-defined treatment failure criterion or discontinued from the study; 3. "NRTI or NNRTI resistance mutations": nucleoside reverse transcriptase inhibitor or lersivirine-associated resistance-associated mutations (RAM) based on the International AIDS Society-USA (IAS-USA) RAM guidelines; 4. 'with result' meant an analyzed sample returned genotypic result or phenotypic result or both.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2010)
  • The percentage of subjects with HIV-1 RNA level <50 copies/mL when all subjects entered in the study from a given parent protocol have reached the end of study. [ Time Frame: 240 weeks ]
  • Change from baseline in CD4+ lymphocyte counts (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol) and when all subjects entered in the study from a given parent protocol have reached the end of study. [ Time Frame: 48 weeks ]
  • Genotypic and phenotypic susceptibility. [ Time Frame: At the time of protocol defined treatment failure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Long Term Open-Label Extension Study Of Lersivirine For The Treatment Of HIV-1 Infection
Brief Summary This is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.
Detailed Description The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1
Intervention  ICMJE
  • Drug: lersivirine
    Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
  • Drug: lersivirine
    Lersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
  • Drug: efavirenz
    Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
  • Drug: lersivirine
    Lersivirine 750 mg tablets PO taken once daily + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI
  • Drug: lersivirine
    Lersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI
  • Drug: etravirine
    Etravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI
Study Arms  ICMJE
  • Experimental: LRV 500mg
    Intervention: Drug: lersivirine
  • Experimental: LRV 750mg +TVD
    Intervention: Drug: lersivirine
  • Active Comparator: EFV
    Intervention: Drug: efavirenz
  • Experimental: LRV 750mg+ DRV/r + OBT
    Intervention: Drug: lersivirine
  • Experimental: LRV 1000mg +DRV/r + OBT
    Intervention: Drug: lersivirine
  • Active Comparator: ETR
    Intervention: Drug: etravirine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 27, 2014)
108
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2010)
165
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must complete of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols (A5271015 or A5271022).
  • Patients must have had a viral load less than 50 copies/mL at Week 84 of the parent protocol.
  • For women who can have children, a negative urine pregnancy test at the Day 1 visit.

Exclusion Criteria:

  • Patients with any Grade 4 Division of AIDS toxicity (except for lipids and asymptomatic glucose elevations will not be included in this trial.
  • Patients being treated with another investigational product or in another clinical trial, except the lersivirine parent protocols will not be included in this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   Italy,   Mexico,   Poland,   South Africa,   Switzerland,   United Kingdom
Removed Location Countries Puerto Rico,   United States
 
Administrative Information
NCT Number  ICMJE NCT01254656
Other Study ID Numbers  ICMJE A5271037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE ViiV Healthcare
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP