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 21, 2013
Last verified: May 2013

December 3, 2010
May 21, 2013
February 2011
April 2013   (final data collection date for primary outcome measure)
  • Safety and tolerability of lersivirine as measured by adverse event reports and safety laboratory tests. [ Time Frame: 240 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01254656 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Genotypic and phenotypic susceptibility. [ Time Frame: At the time of protocol defined treatment failure ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
A Long Term Open-Label Extension Study Of Lersivirine For The Treatment Of HIV-1 Infection

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
110
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Canada,   Italy,   Mexico,   Poland,   South Africa,   Switzerland,   United Kingdom
 
NCT01254656
A5271037
No
Pfizer
Pfizer
ViiV Healthcare
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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