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

May 9, 2011 updated by: Pfizer

A Double Blind- Randomized, Placebo-controlled Study of Two Doses of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Infected Patients Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

179

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

  • France
      • Nantes, France, 44035
        • Pfizer Investigational Site
    • Cedex 02
      • Lyon, Cedex 02, France, 69288
        • Pfizer Investigational Site
    • Cedex 10
      • Paris, Cedex 10, France, 74575
        • Pfizer Investigational Site
    • Cedex 3
      • Lyon, Cedex 3, France, 69437
        • Pfizer Investigational Site
  • Germany
    • Bavaria
      • Ulm, Bavaria, Germany, 89070
        • Pfizer Investigational Site
  • Italy
      • Brescia, Italy, 25123
        • Pfizer Investigational Site
      • Milano, Italy, 20127
        • Pfizer Investigational Site
      • Milano, Italy, 20157
        • Pfizer Investigational Site
      • Roma, Italy, 00149
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa, 7925
        • Pfizer Investigational Site
      • Cape Town, South Africa, 7405
        • Pfizer Investigational Site
      • Johannesburg, South Africa, 2193
        • Pfizer Investigational Site
      • Johannesburg, South Africa, 02198
        • Pfizer Investigational Site
      • Johannesburg, South Africa, 2008
        • Pfizer Investigational Site
      • Pietermaritzburg, South Africa, 3201
        • Pfizer Investigational Site
      • Port Elizabeth, South Africa, 6001
        • Pfizer Investigational Site
      • Pretoria North, South Africa, 0182
        • Pfizer Investigational Site
      • Soweto, South Africa, 2013
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Pfizer Investigational Site
      • Cordoba, Spain, 14004
        • Pfizer Investigational Site
    • Bilbao, Vizcaya
      • Baracaldo, Bilbao, Vizcaya, Spain, 48903
        • Pfizer Investigational Site
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48903
        • Pfizer Investigational Site
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90813
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92663
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94121
        • Pfizer Investigational Site
      • West Hollywood, California, United States, 90069
        • Pfizer Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33311
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33137
        • Pfizer Investigational Site
      • Safety Harbor, Florida, United States, 34695
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33602
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30339-3915
        • Pfizer Investigational Site
      • Jonesboro, Georgia, United States, 30236
        • Pfizer Investigational Site
      • Tucker, Georgia, United States, 30084
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Pfizer Investigational Site
    • New York
      • Brooklyn, New York, United States, 11203
        • Pfizer Investigational Site
      • New York, New York, United States, 10003
        • Pfizer Investigational Site
      • Stony Brook, New York, United States, 11794
        • Pfizer Investigational Site
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27157-1042
        • Pfizer Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44304
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45267
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97209
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Galveston, Texas, United States, 77555
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77009
        • 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:

  • 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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective was to determine whether the addition of capravirine to a regimen of VIRACEPT and 2 new nucleoside reverse transcriptase inhibitors would provide a higher virologic response rate over 48 weeks
when compared to a 3-drug regimen without capravirine in patients who had experienced virologic failure while on a nonnucleoside reverse transcriptase inhibitor regimen.

Secondary Outcome Measures

Outcome Measure
The safety and tolerability of 2 doses of capravirine.
The difference between 2 doses of capravirine in terms of tolerability, efficacy, and pharmacokinetics
The relationship of HIV resistance (genotype and phenotype) to virologic response.
The immunologic response as determined by CD4 and CD8 absolute lymphocyte counts
The population pharmacokinetics of capravirine and VIRACEPT
The pharmacokinetics of potential drug-drug interactions.

Collaborators and Investigators

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

Sponsor

Pfizer

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

August 1, 2002

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

January 16, 2003

First Submitted That Met QC Criteria

January 17, 2003

First Posted (Estimate)

January 20, 2003

Study Record Updates

Last Update Posted (Estimate)

May 10, 2011

Last Update Submitted That Met QC Criteria

May 9, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4311002

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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