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 27, 2014
Last verified: January 2014
  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:
  • Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV‑1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol [ Time Frame: 144 Weeks from Day 1 of the parent protocol ] [ Designated as safety issue: No ]
    Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at 48 weeks i.e. 144 weeks from Day 1 of the parent protocol. Roche Amplicor HIV-1 Monitor assay was used to measure the HIV-1 RNA level.


Secondary Outcome Measures:
  • Number of Participants With Plasma HIV‑1 RNA Level <50 Copies/mL up to Week 208 [ Time Frame: Up to Week 208 ] [ Designated as safety issue: No ]
    Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at last visit. Abbott RealTime HIV-1 assay was used to measure the HIV-1 RNA level.

  • Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol [ Time Frame: 144 Weeks from Day 1 of the parent protocol ] [ Designated as safety issue: No ]
    Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)

  • Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol [ Time Frame: 144 Weeks from Day 1 of the parent protocol ] [ Designated as safety issue: No ]
    Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)

  • Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol [ Time Frame: 192 Weeks from Day 1 of the parent protocol ] [ Designated as safety issue: No ]
    Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.

  • Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol [ Time Frame: 192 Weeks from Day 1 of the parent protocol ] [ Designated as safety issue: No ]
    Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.

  • Virology Analysis Participant Accountability From Week 96 Through Study Termination [ Time Frame: Week 96 through study termination ] [ Designated as safety issue: No ]
    Virology analysis included virus susceptibility (phenotype and genotype)to a standard panel of approved antiretrovirals as determined by the Monogram Biosciences PhenoSense GT assay. Below analysis table included the following parameters: 1. "protocol-defined treatment failure" was defined as an increase in HIV-1 RNA to detectable levels (≥50 copies/mL) on 2 consecutive measurements, the second measurement taken no more than 14 days after the first measurement); 2. "Treatment failure": treatment failure (both virologic and non-virologic) was defined as a subject who met the protocol-defined treatment failure criterion or discontinued from the study; 3. "NRTI or NNRTI resistance mutations": nucleoside reverse transcriptase inhibitor or lersivirine-associated resistance-associated mutations (RAM) based on the International AIDS Society-USA (IAS-USA) RAM guidelines; 4. 'with result' meant an analyzed sample returned genotypic result or phenotypic result or both.


Enrollment: 108
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 5B1
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 4P9
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
Results First Received: January 21, 2014
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Etravirine
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

ClinicalTrials.gov processed this record on October 01, 2014