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

NCT ID: NCT00824369

Last Updated: 2014-08-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV-1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Anti-retroviral therapy

Anti-retroviral therapy

Group Type NO_INTERVENTION

No drug will be administered

Intervention Type DRUG

No drug will be administered.

Interventions

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No drug will be administered

No drug will be administered.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ViiV Healthcare

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Sacramento, California, United States

Site Status

Pfizer Investigational Site

Sacramento, California, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Atlanta, Georgia, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

Buenos Aires, , Argentina

Site Status

Pfizer Investigational Site

Curitiba, Paraná, Brazil

Site Status

Pfizer Investigational Site

Nova Iguaçu, Rio de Janeiro, Brazil

Site Status

Pfizer Investigational Site

Campinas, São Paulo, Brazil

Site Status

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Kota Bharu, Kelantan, Malaysia

Site Status

Pfizer Investigational Site

Warsaw, , Poland

Site Status

Pfizer Investigational Site

Lisbon, , Portugal

Site Status

Pfizer Investigational Site

Porto, , Portugal

Site Status

Pfizer Investigational Site

Ponce, , Puerto Rico

Site Status

Pfizer Investigational Site

Santurce, , Puerto Rico

Site Status

Pfizer Investigational Site

Dundee, KwaZulu-Natal, South Africa

Site Status

Pfizer Investigational Site

Cape Town, Western Cape, South Africa

Site Status

Pfizer Investigational Site

Lugano, , Switzerland

Site Status

Pfizer Investigational Site

Sankt Gallen, , Switzerland

Site Status

Pfizer Investigational Site

Donetsk, , Ukraine

Site Status

Pfizer Investigational Site

Edinburgh, , United Kingdom

Site Status

Pfizer Investigational Site

Edinburgh, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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United States Argentina Brazil Italy Malaysia Poland Portugal Puerto Rico South Africa Switzerland Ukraine United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5271038&StudyName=A%20Rollover%20Study%20For%20Subjects%20Discontinuing%20From%20UK-453%2C061%20Studies%20For%20The%20Treatment%20Of%20HIV-1

To obtain contact information for a study center near you, click here.

Other Identifiers

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A5271038

Identifier Type: -

Identifier Source: org_study_id

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