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

July 31, 2014 updated by: Pfizer

A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1405BCH
        • Pfizer Investigational Site
  • Brazil
    • PR
      • Curitiba, PR, Brazil, 80240-280
        • Pfizer Investigational Site
    • RJ
      • Nova Iguacu, RJ, Brazil, 26030-381
        • Pfizer Investigational Site
    • SP
      • Campinas, SP, Brazil, 13015-080
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 04121-000
        • Pfizer Investigational Site
  • Italy
      • Milano, Italy, 20127
        • Pfizer Investigational Site
  • Malaysia
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • Pfizer Investigational Site
  • Poland
      • Warszawa, Poland, 01-201
        • Pfizer Investigational Site
  • Portugal
      • Lisboa, Portugal, 1349-019
        • Pfizer Investigational Site
      • Porto, Portugal, 4200-319
        • Pfizer Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00717-1563
        • Pfizer Investigational Site
      • Santurce, Puerto Rico, 00909
        • Pfizer Investigational Site
  • South Africa
    • Kwazulu-Natal
      • Dundee, Kwazulu-Natal, South Africa, 3000
        • Pfizer Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Pfizer Investigational Site
  • Switzerland
      • Lugano, Switzerland, 6903
        • Pfizer Investigational Site
      • St. Gallen, Switzerland, 9007
        • Pfizer Investigational Site
  • Ukraine
      • Donetsk, Ukraine, 83045
        • Pfizer Investigational Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Pfizer Investigational Site
      • Edinburgh, United Kingdom, EH3 9HA
        • Pfizer Investigational Site
      • London, United Kingdom, SW10 9NH
        • Pfizer Investigational Site
      • Manchester, United Kingdom, M8 5RB
        • Pfizer Investigational Site
  • United States
    • California
      • Sacramento, California, United States, 95817
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95814
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33137
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Anti-retroviral therapy
Drug: No drug will be administered
No drug will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events
Time Frame: 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.
End of Study visit or the Early Termination visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: Baseline, Month 6 and Month 12
Participant's immunological status assessed by CD4+ lymphocyte count.
Baseline, Month 6 and Month 12
CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12
Time Frame: Baseline, Month 6 and Month 12
Participant's immunological status assessed by CD4+ lymphocyte count.
Baseline, Month 6 and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

ViiV Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (Estimate)

January 16, 2009

Study Record Updates

Last Update Posted (Estimate)

August 4, 2014

Last Update Submitted That Met QC Criteria

July 31, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A5271038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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