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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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Darlinghurst, New South Wales, 2010 Australia
Contact
1-800-718-1021
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.

NCT01254656
Pfizer
Terminated
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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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
Intervention Model: Parallel Assignment
Masking: None (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
108
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Canada,   Italy,   Mexico,   Poland,   South Africa,   Switzerland,   United Kingdom
Puerto Rico,   United States
 
NCT01254656
A5271037
No
Not Provided
Not Provided
Pfizer
Pfizer
ViiV Healthcare
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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