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
  Purpose

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.


Condition Intervention Phase
HIV-1
Drug: lersivirine
Drug: efavirenz
Drug: etravirine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long Term Open-Label Extension Study Of Lersivirine For The Treatment Of HIV-1 Infection

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 110
Study Start Date: February 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LRV 500mg Drug: lersivirine
Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
Experimental: LRV 750mg +TVD Drug: lersivirine
Lersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
Active Comparator: EFV Drug: efavirenz
Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
Experimental: LRV 750mg+ DRV/r + OBT 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
Experimental: LRV 1000mg +DRV/r + OBT Drug: lersivirine
Lersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI
Active Comparator: ETR Drug: etravirine
Etravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254656

Locations
Australia, New South Wales
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
Pfizer Investigational Site
Melbourne, Victoria, Australia, 3004
Brazil
Pfizer Investigational Site
Nova Iguacu, RJ, Brazil, 26030-381
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 1K2
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 4P9
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 5B1
Italy
Pfizer Investigational Site
Milano, Italy, 20127
Pfizer Investigational Site
Torino, Italy, 10149
Mexico
Pfizer Investigational Site
Mexico, Distrito Federal, Mexico, 14050
Poland
Pfizer Investigational Site
Bydgoszcz, Poland, 85-030
Pfizer Investigational Site
Warszawa, Poland, 01-201
South Africa
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa, 2193
Pfizer Investigational Site
Pretoria, Gauteng, South Africa, 0083
Pfizer Investigational Site
Soweto, Gauteng, South Africa, 2013
Pfizer Investigational Site
Durban, Kwazulu-Natal, South Africa, 4001
Pfizer Investigational Site
Cape Town, Western Cape, South Africa, 7925
Pfizer Investigational Site
Pretoria, South Africa, 0083
Switzerland
Pfizer Investigational Site
Lugano, Switzerland, 6903
Pfizer Investigational Site
St. Gallen, Switzerland, 9007
Pfizer Investigational Site
Zuerich, Switzerland, 8091
United Kingdom
Pfizer Investigational Site
Brighton, East Sussex, United Kingdom, BN2 1ES
Pfizer Investigational Site
London, United Kingdom, SW10 9NH
Pfizer Investigational Site
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Pfizer
ViiV Healthcare
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01254656     History of Changes
Other Study ID Numbers: A5271037
Study First Received: December 3, 2010
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 14, 2014