Clinical trial NCT00824369: A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1
Official title: A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV-1
Keywords: HIV-1
Rollover
Safety.
HIV Infections
treatment experienced
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: ViiV Healthcare
First posted: 2009-01-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.

Detailed description: To assess long term safety and tolerability of subjects who discontinue for any reason from UK-453,061 studies. The study will also assess efficacy of the subsequent regimens in these patients. 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:

* Previous participation in a qualifying study.
* Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.

Exclusion Criteria:

* Concurrent treatment in another clinical trial.
* Unwilling or unable to be followed for 12 months

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events
timeFrame: End of Study visit or the Early Termination visit
Secondary outcomes:
measure: Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit
timeFrame: Baseline, Month 6, Month 12 and Last visit
measure: Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit
timeFrame: Baseline, Month 6, Month 12 and Last visit
measure: Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12
timeFrame: Baseline, Month 6 and Month 12
measure: CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12
timeFrame: Baseline, Month 6 and Month 12
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Nova Iguacu
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Campinas
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Kota Bharu
country: Malaysia
facility: Pfizer Investigational Site
state: Kelantan
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Ponce
country: Puerto Rico
facility: Pfizer Investigational Site
city: Santurce
country: Puerto Rico
facility: Pfizer Investigational Site
city: Dundee
country: South Africa
facility: Pfizer Investigational Site
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Lugano
country: Switzerland
facility: Pfizer Investigational Site
city: St. Gallen
country: Switzerland
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: