NCT01254656

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-12-06
• Last updated: 2014-06-09
• Results posted: 2014-06-09

Locations

23 sites across 9 countries: Australia, Brazil, Canada, Italy, Mexico, Poland, South Africa, Switzerland, United Kingdom