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

Phase 2

Terminated

• Conditions: HIV-1
• Interventions: Drug: No drug will be administered

• Registration Number: NCT00824369
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-16
• Study Start: 2009-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2014-01-16
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-31
• Last Update Submitted: 2014-07-31
• Results First Posted: 2014-08-04
• Last Update Posted: 2014-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-retroviral therapy	No drug will be administered	Anti-retroviral therapy

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events	End of Study visit or the Early Termination visit	The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12	Baseline, Month 6 and Month 12	Participant's immunological status assessed by CD4+ lymphocyte count.
CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12	Baseline, Month 6 and Month 12	Participant's immunological status assessed by CD4+ lymphocyte count.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Manchester, United Kingdom