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

HIV-1 Clinical Trial

Official title:

A Long Term Open-Label Extension Study Of Lersivirine For The Treatment Of HIV-1 Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01254656
• Other study ID #: A5271037
• Status: Terminated
• Phase: Phase 2
• First received: December 3, 2010
• Last updated: May 27, 2014
• Start date: February 2011
• Est. completion date: April 2013

Study information

• Verified date: January 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-1

Intervention

Drug:
• lersivirine
Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
• lersivirine
Lersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
• efavirenz
Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
• 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
• lersivirine
Lersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI
• etravirine
Etravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Darlinghurst	New South Wales
Australia	Pfizer Investigational Site	Melbourne	Victoria
Brazil	Pfizer Investigational Site	Nova Iguacu	RJ
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Torino
Mexico	Pfizer Investigational Site	Mexico	Distrito Federal
Poland	Pfizer Investigational Site	Bydgoszcz
Poland	Pfizer Investigational Site	Warszawa
South Africa	Pfizer Investigational Site	Cape Town	Western Cape
South Africa	Pfizer Investigational Site	Durban	Kwazulu-Natal
South Africa	Pfizer Investigational Site	Johannesburg	Gauteng
South Africa	Pfizer Investigational Site	Pretoria	Gauteng
South Africa	Pfizer Investigational Site	Pretoria
South Africa	Pfizer Investigational Site	Soweto	Gauteng
Switzerland	Pfizer Investigational Site	Lugano
Switzerland	Pfizer Investigational Site	St. Gallen
Switzerland	Pfizer Investigational Site	Zuerich
United Kingdom	Pfizer Investigational Site	Brighton	East Sussex
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	ViiV Healthcare

Countries where clinical trial is conducted

Australia,  Brazil,  Canada,  Italy,  Mexico,  Poland,  South Africa,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	144 Weeks from Day 1 of the parent protocol	No
Secondary	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.	Up to Week 208	No
Secondary	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)	144 Weeks from Day 1 of the parent protocol	No
Secondary	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)	144 Weeks from Day 1 of the parent protocol	No
Secondary	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.	192 Weeks from Day 1 of the parent protocol	No
Secondary	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.	192 Weeks from Day 1 of the parent protocol	No
Secondary	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.	Week 96 through study termination	No

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