Clinical trial NCT01254656: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV-1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: ViiV Healthcare
First posted: 2010-12-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: 144 Weeks from Day 1 of the parent protocol
Secondary outcomes:
measure: Number of Participants With Plasma HIV-1 RNA Level <50 Copies/mL up to Week 208
timeFrame: Up to Week 208
measure: Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol
timeFrame: 144 Weeks from Day 1 of the parent protocol
measure: Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol
timeFrame: 144 Weeks from Day 1 of the parent protocol
measure: Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol
timeFrame: 192 Weeks from Day 1 of the parent protocol
measure: Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol
timeFrame: 192 Weeks from Day 1 of the parent protocol
measure: Virology Analysis Participant Accountability From Week 96 Through Study Termination
timeFrame: Week 96 through study termination
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Melbourne
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Nova Iguacu
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: Distrito Federal
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Soweto
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Pfizer Investigational Site
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
city: Lugano
country: Switzerland
facility: Pfizer Investigational Site
city: St. Gallen
country: Switzerland
facility: Pfizer Investigational Site
city: Zuerich
country: Switzerland
facility: Pfizer Investigational Site
city: Brighton
country: United Kingdom
facility: Pfizer Investigational Site
state: East Sussex
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: