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

May 27, 2014 updated by: Pfizer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LRV 500mg
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: 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
Experimental: LRV 750mg +TVD
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: 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
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 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: 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
Experimental: LRV 1000mg +DRV/r + OBT
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: 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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
144 Weeks from Day 1 of the parent protocol

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Plasma HIV-1 RNA Level <50 Copies/mL up to Week 208
Time Frame: Up to Week 208
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.
Up to Week 208
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
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)
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
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)
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
Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.
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
Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.
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
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.
Week 96 through study termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ViiV Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A5271037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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