A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1

Phase 2TerminatedNCT00824369

Pfizer52 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

HIV-1

Interventions

No drug will be administeredDRUG

No drug will be administered.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Pfizer Investigational Site

Outcomes

Primary Outcomes

Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events

The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.

Time frame: End of Study visit or the Early Termination visit

Secondary Outcomes

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

Number of participants with HIV-1 RNA level \<50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.

Time frame: Baseline, Month 6, Month 12 and Last visit

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

Number of participants with HIV-1 RNA level \<50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.

Time frame: Baseline, Month 6, Month 12 and Last visit

Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12

Participant's immunological status assessed by CD4+ lymphocyte count.

Time frame: Baseline, Month 6 and Month 12

CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12

Participant's immunological status assessed by CD4+ lymphocyte count.

Time frame: Baseline, Month 6 and Month 12

Data from ClinicalTrials.gov

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