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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

Primary Purpose

HIV-1

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
lersivirine
lersivirine
efavirenz
lersivirine
lersivirine
etravirine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

LRV 500mg

LRV 750mg +TVD

EFV

LRV 750mg+ DRV/r + OBT

LRV 1000mg +DRV/r + OBT

ETR

Arm Description

Outcomes

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
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
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
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
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
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
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
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.

Full Information

First Posted
December 3, 2010
Last Updated
May 27, 2014
Sponsor
Pfizer
Collaborators
ViiV Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01254656
Brief Title
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
Official Title
A Long Term Open-Label Extension Study Of Lersivirine For The Treatment Of HIV-1 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
ViiV Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LRV 500mg
Arm Type
Experimental
Arm Title
LRV 750mg +TVD
Arm Type
Experimental
Arm Title
EFV
Arm Type
Active Comparator
Arm Title
LRV 750mg+ DRV/r + OBT
Arm Type
Experimental
Arm Title
LRV 1000mg +DRV/r + OBT
Arm Type
Experimental
Arm Title
ETR
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
lersivirine
Intervention Description
Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
Intervention Type
Drug
Intervention Name(s)
lersivirine
Intervention Description
Lersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
Intervention Type
Drug
Intervention Name(s)
efavirenz
Intervention Description
Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
Intervention Type
Drug
Intervention Name(s)
lersivirine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
lersivirine
Intervention Description
Lersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI
Intervention Type
Drug
Intervention Name(s)
etravirine
Intervention Description
Etravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
144 Weeks from Day 1 of the parent protocol
Secondary Outcome Measure Information:
Title
Number of Participants With Plasma HIV-1 RNA Level <50 Copies/mL up to Week 208
Description
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.
Time Frame
Up to Week 208
Title
Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol
Description
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)
Time Frame
144 Weeks from Day 1 of the parent protocol
Title
Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol
Description
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)
Time Frame
144 Weeks from Day 1 of the parent protocol
Title
Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol
Description
Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.
Time Frame
192 Weeks from Day 1 of the parent protocol
Title
Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol
Description
Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.
Time Frame
192 Weeks from Day 1 of the parent protocol
Title
Virology Analysis Participant Accountability From Week 96 Through Study Termination
Description
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.
Time Frame
Week 96 through study termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Pfizer Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nova Iguacu
State/Province
RJ
ZIP/Postal Code
26030-381
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1K2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10149
Country
Italy
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Pfizer Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pretoria
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Lugano
ZIP/Postal Code
6903
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5271037&StudyName=A%20Long%20Term%20Safety%20Study%20Of%20Lersivirine%20For%20The%20Treatment%20Of%20HIV-1%20Infection%20In%20Subjects%20Who%20Have%20Completed%20Treatment%20With%20Lersivirine
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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