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

NCT01254656

Last updated date
Study Location
Pfizer Investigational Site
Darlinghurst, New South Wales, 2010, Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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 CenterPfizer
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