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

Phase 2

Terminated

• Conditions: HIV-1
• Interventions: Drug: lersivirine; Drug: etravirine; Drug: efavirenz

• Registration Number: NCT01254656
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Study Start: 2011-02
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-01
• Results First Submitted: 2014-01-21
• Results First Submitted QC: 2014-05-27
• Last Update Submitted: 2014-05-27
• Results First Posted: 2014-06-09
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 108

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LRV 1000mg +DRV/r + OBT	lersivirine	-
ETR	etravirine	-
EFV	efavirenz	-
LRV 750mg+ DRV/r + OBT	lersivirine	-
LRV 500mg	lersivirine	-
LRV 750mg +TVD	lersivirine	-

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Number of Participants With Plasma HIV-1 RNA Level <50 Copies/mL up to Week 208	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	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	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	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	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	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 London, United Kingdom