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Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen

NCT ID: NCT00051844

Last Updated: 2011-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2004-11-30

Brief Summary

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This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Capravirine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female at least 18 years old
* HIV RNA level \>1000 copies/mL at screening
* CD4 \>50 cells/uL at screening
* Patient is currently taking a regimen that includes an NNRTI plus 2 NRTIs for at least 28 days and is currently failing this regimen
* Patient has adequate hematology tests (absolute neutrophil count \>1000/uL, Platelets\>75,000uL, hemoglobin 9g/L)
* Patient has adequate renal function (serum creatinine of \<1.5 upper limit of normal)
* Patient has adequate liver function (AST, ALT, and bilirubin \< 2.5 upper limit of normal)

Exclusion Criteria

* Previous use of protease inhibitors (except if patient has short duration of PI and was switched for tolerability reasons when viral load was \<50 copies) This exception does not include Viracept
* Women who are pregnant or lactating
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Locations

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Pfizer Investigational Site

Beverly Hills, California, United States

Site Status

Pfizer Investigational Site

Long Beach, California, United States

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Pfizer Investigational Site

Newport Beach, California, United States

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Pfizer Investigational Site

San Francisco, California, United States

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Pfizer Investigational Site

San Francisco, California, United States

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Pfizer Investigational Site

West Hollywood, California, United States

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Pfizer Investigational Site

Fort Lauderdale, Florida, United States

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Pfizer Investigational Site

Miami, Florida, United States

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Pfizer Investigational Site

Safety Harbor, Florida, United States

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Pfizer Investigational Site

Tampa, Florida, United States

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Pfizer Investigational Site

Atlanta, Georgia, United States

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Pfizer Investigational Site

Jonesboro, Georgia, United States

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Pfizer Investigational Site

Tucker, Georgia, United States

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Pfizer Investigational Site

Chicago, Illinois, United States

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Wichita, Kansas, United States

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Jackson, Mississippi, United States

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Brooklyn, New York, United States

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Pfizer Investigational Site

New York, New York, United States

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Pfizer Investigational Site

Stony Brook, New York, United States

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Pfizer Investigational Site

Huntersville, North Carolina, United States

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Pfizer Investigational Site

Winston-Salem, North Carolina, United States

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Pfizer Investigational Site

Akron, Ohio, United States

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Pfizer Investigational Site

Cincinnati, Ohio, United States

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Pfizer Investigational Site

Portland, Oregon, United States

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Pfizer Investigational Site

Portland, Oregon, United States

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Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

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Pfizer Investigational Site

Austin, Texas, United States

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Pfizer Investigational Site

Dallas, Texas, United States

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Pfizer Investigational Site

Galveston, Texas, United States

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Pfizer Investigational Site

Houston, Texas, United States

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Pfizer Investigational Site

Lyon, Cedex 02, France

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Pfizer Investigational Site

Paris, Cedex 10, France

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Pfizer Investigational Site

Lyon, Cedex 3, France

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Pfizer Investigational Site

Nantes, , France

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Pfizer Investigational Site

Ulm, Bavaria, Germany

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Pfizer Investigational Site

Brescia, , Italy

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Pfizer Investigational Site

Milan, , Italy

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Pfizer Investigational Site

Milan, , Italy

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Pfizer Investigational Site

Roma, , Italy

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Pfizer Investigational Site

Cape Town, , South Africa

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Pfizer Investigational Site

Cape Town, , South Africa

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Pfizer Investigational Site

Johannesburg, , South Africa

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Pfizer Investigational Site

Johannesburg, , South Africa

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Pfizer Investigational Site

Johannesburg, , South Africa

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Pfizer Investigational Site

Pietermaritzburg, , South Africa

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Pfizer Investigational Site

Port Elizabeth, , South Africa

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Pfizer Investigational Site

Pretoria North, , South Africa

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Pfizer Investigational Site

Soweto, , South Africa

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Pfizer Investigational Site

Barakaldo, Bilbao, Vizcaya, Spain

Site Status

Pfizer Investigational Site

Bilbao, Vizcaya, Spain

Site Status

Pfizer Investigational Site

Barcelona, , Spain

Site Status

Pfizer Investigational Site

Córdoba, , Spain

Site Status

Countries

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United States France Germany Italy South Africa Spain

Other Identifiers

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A4311002

Identifier Type: -

Identifier Source: org_study_id

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