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

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00028067
First received: December 10, 2001
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Atazanavir
Drug: Nelfinavir mesylate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment: 500
Study Start Date: August 2001
Study Completion Date: April 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028067

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00028067     History of Changes
Other Study ID Numbers: 302F, AI424-037
Study First Received: December 10, 2001
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Drug Therapy, Combination
HIV Protease Inhibitors
RNA, Viral
Reverse Transcriptase Inhibitors
Viral Load
BMS 232632

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Atazanavir
HIV Protease Inhibitors
Nelfinavir
Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014