A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor

April 28, 2011 updated by: Bristol-Myers Squibb

A Phase III Study Comparing the Antiviral Efficacy and Safety of Atazanavir With Nelfinavir: Each in Combination With Dual Nucleoside Therapy in HIV-Infected Subjects Who Have Failed a Regimen Not Containing a Protease Inhibitor

The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.

Study Overview

Status

Terminated

Conditions

Detailed Description

In this double-blind, double-placebo, randomized, 2-arm study, atazanavir and NFV each are given in combination with 2 open-label nucleoside reverse transcriptase inhibitors (NRTIs) over 48 weeks. Patients assigned to atazanavir will receive placebo capsules which are identical in size and appearance to NFV. Patients assigned to NFV will receive placebo capsules which are identical in size and appearance to atazanavir. HIV levels are monitored.

Study Type

Interventional

Enrollment

500

Phase

  • Phase 3

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

    • British Columbia
      • Vancouver, British Columbia, Canada
        • Downtown Infectious Diseases Clinic
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster Univ Med Ctr
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Ctr
    • Quebec
      • Montreal, Quebec, Canada
        • Clinique Medicale du Quartier Latin
      • Montreal, Quebec, Canada
        • Clinique Medicale L'Actuele
      • Mexico City, Mexico
        • Instituto Nacional de la Nutricion
      • Mexico City, Mexico
        • Hospital General de Mexico
      • Mexico City, Mexico
        • Instituto Nacional de Enfermedades Respiratorias
      • Mexico City, Mexico
        • Hospital Regional
      • Ponce, Puerto Rico, 00732
        • Ponce School of Medicine
      • Santruce, Puerto Rico, 00909
        • Hepatology / Infectious Diseases
      • Bangkok, Thailand
        • Program on AIDS / Thai Red Cross Society
      • Bangkok, Thailand
        • Ramathibodi Hosp
      • Bangkok, Thailand
        • Siriraj Hosp / Mahidol Univ
      • Khonkaen, Thailand
        • Khonkaen Univ
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Health for Life Clinic
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • Fountain Valley, California, United States, 92708
        • Orange County Ctr for Special Immunology
      • Los Angeles, California, United States, 90048
        • Tower Infectious Diseases
      • Sacramento, California, United States, 95825
        • Kaiser Hospital
      • San Francisco, California, United States, 94118
        • Kaiser Foundation Hospital
      • San Francisco, California, United States, 94114
        • HIV Institute / Davies Med Ctr
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • IDC Research Initiative
      • Atlantis, Florida, United States, 33462
        • Larry Bush
      • Bradenton, Florida, United States, 34205
        • Bach and Godofsky
      • Fort Lauderdale, Florida, United States, 33316
        • Gary Richmond MD
      • Fort Lauderdale, Florida, United States, 33311
        • North Broward Hosp District / HIV Clinical Research
      • Sarasota, Florida, United States, 34239
        • Infectious Diseases Associates
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Inst
      • Tampa, Florida, United States, 33607
        • Daniel Seekins
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Philip Brachman
      • Augusta, Georgia, United States, 30912
        • Med College of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Gen Hosp / Division of Infect Diseases
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Division of Inf Diseases/ Indiana Univ Hosp
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Univ School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med Ctr
      • Brookline, Massachusetts, United States, 02445
        • Community Research Initiative of New England
      • Springfield, Massachusetts, United States, 01107
        • CRI - Springfield
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp
      • Warren, Michigan, United States, 48089
        • Infectious disease clinic
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Washington Univ School of Medicine
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
        • South Jersey Infectious Diseases Inc
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10019
        • Saint Luke's - Roosevelt Hosp Ctr
      • New York, New York, United States, 10018
        • Community Research Initiative on AIDS
    • North Carolina
      • Charlotte, North Carolina, United States, 28232
        • Carolinas Med Ctr
      • Hickory, North Carolina, United States, 28602
        • Piedmont Infectious Disease Consultants
      • Huntersville, North Carolina, United States, 28078
        • Jemsek Clinic
      • Winston Salem, North Carolina, United States, 27157
        • Wake Forest Univ School of Medicine
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Associates in Med and Mental Health
    • Oregon
      • Portland, Oregon, United States, 97209
        • Research & Education Group
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Hahnemann Univ Hosp
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Ludwig Lettau Private Practice
      • Columbia, South Carolina, United States, 29203
        • Univ of South Carolina School of Medicine
    • Texas
      • Dallas, Texas, United States, 75390
        • Univ of Texas Southwestern Med Ctr
      • Dallas, Texas, United States, 75208
        • North Texas Center for AIDS & Clinical Research
      • Houston, Texas, United States, 77004
        • Joseph Gathe
      • Houston, Texas, United States, 77030
        • Univ TX Health Science Ctr
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Hampton Roads Med Specialists
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53203
        • Wisconsin AIDS Research Consortium

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Have a viral load of 1000 or more copies/ml within 3 weeks before randomization. Have a CD4 cell count of 50 or more cells/mm3 within 3 weeks prior to randomization.
  • Are at least 16 years old (or the minimum age by local requirements).
  • Have had more than 16 weeks of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and/or nucleoside reverse transcriptase inhibitor (NRTI).
  • Use effective barrier method of contraception.
  • Give written informed consent.
  • Are available for follow-up for at least 52 weeks.

Exclusion Criteria

Patients may not be eligible for this study if they:

  • Have used a protease inhibitor (PI) treatment for more than 7 days or within 30 days prior to screening.
  • Have a newly-diagnosed HIV-related infection or any medical condition requiring relatively short but intense therapy at the time of enrollment.
  • Have hepatitis in the 30 days before the study. Patients with long-term hepatitis are eligible if their liver function meets certain requirements.
  • Are unable to demonstrate responsiveness to a provided NRTI.
  • Have had previous or expect a need for therapy with agents that may cause damage to nerve tissue, the pancreas, the liver, bone marrow, or cells within 3 months of study start.
  • Use too much alcohol or drugs to be able to follow the study therapy; or if they use enough to increase the risk of developing pancreatitis or chemical hepatitis.
  • Have severe diarrhea within 30 days prior to study entry.
  • Are pregnant or breast-feeding.
  • Have a history of hemophilia.
  • Have history or signs of bilateral peripheral neuropathy.
  • Have cardiomyopathy.
  • Have certain heart problems.
  • Cannot tolerate oral medication.
  • Have any other problems that would interfere with the study.

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

Collaborators and Investigators

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

Investigators

  • Study Director: Michael Giordano

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, 2001

Primary Completion (Actual)

April 1, 2002

Study Completion (Actual)

April 1, 2002

Study Registration Dates

First Submitted

December 10, 2001

First Submitted That Met QC Criteria

December 10, 2001

First Posted (Estimate)

December 11, 2001

Study Record Updates

Last Update Posted (Estimate)

May 4, 2011

Last Update Submitted That Met QC Criteria

April 28, 2011

Last Verified

April 1, 2011

More Information

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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