- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00028067
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
Intervention / Treatment
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
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British Columbia
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Vancouver, British Columbia, Canada
- Downtown Infectious Diseases Clinic
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Ontario
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Hamilton, Ontario, Canada
- McMaster Univ Med Ctr
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Toronto, Ontario, Canada
- Sunnybrook Health Science Ctr
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Quebec
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Montreal, Quebec, Canada
- Clinique Medicale du Quartier Latin
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Montreal, Quebec, Canada
- Clinique Medicale L'Actuele
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Mexico City, Mexico
- Instituto Nacional de la Nutricion
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Mexico City, Mexico
- Hospital General de Mexico
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Mexico City, Mexico
- Instituto Nacional de Enfermedades Respiratorias
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Mexico City, Mexico
- Hospital Regional
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Ponce, Puerto Rico, 00732
- Ponce School of Medicine
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Santruce, Puerto Rico, 00909
- Hepatology / Infectious Diseases
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Bangkok, Thailand
- Program on AIDS / Thai Red Cross Society
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Bangkok, Thailand
- Ramathibodi Hosp
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Bangkok, Thailand
- Siriraj Hosp / Mahidol Univ
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Khonkaen, Thailand
- Khonkaen Univ
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Health for Life Clinic
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California
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Berkeley, California, United States, 94705
- East Bay AIDS Ctr
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Fountain Valley, California, United States, 92708
- Orange County Ctr for Special Immunology
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Los Angeles, California, United States, 90048
- Tower Infectious Diseases
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Sacramento, California, United States, 95825
- Kaiser Hospital
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San Francisco, California, United States, 94118
- Kaiser Foundation Hospital
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San Francisco, California, United States, 94114
- HIV Institute / Davies Med Ctr
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Florida
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Altamonte Springs, Florida, United States, 32701
- IDC Research Initiative
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Atlantis, Florida, United States, 33462
- Larry Bush
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Bradenton, Florida, United States, 34205
- Bach and Godofsky
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Fort Lauderdale, Florida, United States, 33316
- Gary Richmond MD
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Fort Lauderdale, Florida, United States, 33311
- North Broward Hosp District / HIV Clinical Research
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Sarasota, Florida, United States, 34239
- Infectious Diseases Associates
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Tampa, Florida, United States, 33614
- Infectious Disease Research Inst
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Tampa, Florida, United States, 33607
- Daniel Seekins
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Georgia
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Atlanta, Georgia, United States, 30309
- Philip Brachman
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Augusta, Georgia, United States, 30912
- Med College of Georgia
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Illinois
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Chicago, Illinois, United States, 60612
- Cook County Gen Hosp / Division of Infect Diseases
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Indiana
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Indianapolis, Indiana, United States, 46202
- Division of Inf Diseases/ Indiana Univ Hosp
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane Univ School of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Med Ctr
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Brookline, Massachusetts, United States, 02445
- Community Research Initiative of New England
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Springfield, Massachusetts, United States, 01107
- CRI - Springfield
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hosp
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Warren, Michigan, United States, 48089
- Infectious disease clinic
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Missouri
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St Louis, Missouri, United States, 63108
- Washington Univ School of Medicine
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New Jersey
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Somers Point, New Jersey, United States, 08244
- South Jersey Infectious Diseases Inc
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New York
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Bronx, New York, United States, 10461
- Albert Einstein College of Medicine
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New York, New York, United States, 10029
- Mount Sinai Med Ctr
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New York, New York, United States, 10019
- Saint Luke's - Roosevelt Hosp Ctr
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New York, New York, United States, 10018
- Community Research Initiative on AIDS
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North Carolina
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Charlotte, North Carolina, United States, 28232
- Carolinas Med Ctr
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Hickory, North Carolina, United States, 28602
- Piedmont Infectious Disease Consultants
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Huntersville, North Carolina, United States, 28078
- Jemsek Clinic
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Winston Salem, North Carolina, United States, 27157
- Wake Forest Univ School of Medicine
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Ohio
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Akron, Ohio, United States, 44304
- Summa Health System
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Oklahoma
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Tulsa, Oklahoma, United States, 74114
- Associates in Med and Mental Health
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Oregon
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Portland, Oregon, United States, 97209
- Research & Education Group
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19102
- Hahnemann Univ Hosp
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South Carolina
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Charleston, South Carolina, United States, 29414
- Ludwig Lettau Private Practice
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Columbia, South Carolina, United States, 29203
- Univ of South Carolina School of Medicine
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Texas
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Dallas, Texas, United States, 75390
- Univ of Texas Southwestern Med Ctr
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Dallas, Texas, United States, 75208
- North Texas Center for AIDS & Clinical Research
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Houston, Texas, United States, 77004
- Joseph Gathe
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Houston, Texas, United States, 77030
- Univ TX Health Science Ctr
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Virginia
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Hampton, Virginia, United States, 23666
- Hampton Roads Med Specialists
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Wisconsin
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Milwaukee, Wisconsin, United States, 53203
- Wisconsin AIDS Research Consortium
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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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Nelfinavir
- Atazanavir Sulfate
Other Study ID Numbers
- 302F
- AI424-037
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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