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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

NCT01254656 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2014-06-09

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Australia
  • Brazil
  • Canada
  • Italy
  • Mexico
  • Poland
  • South Africa
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01254656 on ClinicalTrials.gov