A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor
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
2 other identifiers
interventional
500
5 countries
62
Brief Summary
The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
Started Aug 2001
Shorter than P25 for phase_3 hiv-infections
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 10, 2001
CompletedFirst Posted
Study publicly available on registry
December 11, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2002
CompletedMay 4, 2011
April 1, 2011
8 months
December 10, 2001
April 28, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Health for Life Clinic
Little Rock, Arkansas, 72205, United States
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708, United States
Tower Infectious Diseases
Los Angeles, California, 90048, United States
Kaiser Hospital
Sacramento, California, 95825, United States
HIV Institute / Davies Med Ctr
San Francisco, California, 94114, United States
Kaiser Foundation Hospital
San Francisco, California, 94118, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Larry Bush
Atlantis, Florida, 33462, United States
Bach and Godofsky
Bradenton, Florida, 34205, United States
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, 33311, United States
Gary Richmond MD
Fort Lauderdale, Florida, 33316, United States
Infectious Diseases Associates
Sarasota, Florida, 34239, United States
Daniel Seekins
Tampa, Florida, 33607, United States
Infectious Disease Research Inst
Tampa, Florida, 33614, United States
Philip Brachman
Atlanta, Georgia, 30309, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
Cook County Gen Hosp / Division of Infect Diseases
Chicago, Illinois, 60612, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Community Research Initiative of New England
Brookline, Massachusetts, 02445, United States
CRI - Springfield
Springfield, Massachusetts, 01107, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Infectious Disease Clinic
Warren, Michigan, 48089, United States
Washington Univ School of Medicine
St Louis, Missouri, 63108, United States
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244, United States
Community Research Initiative on AIDS
New York, New York, 10018, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28232, United States
Piedmont Infectious Disease Consultants
Hickory, North Carolina, 28602, United States
Jemsek Clinic
Huntersville, North Carolina, 28078, United States
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, 27157, United States
Summa Health System
Akron, Ohio, 44304, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114, United States
Research & Education Group
Portland, Oregon, 97209, United States
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102, United States
Ludwig Lettau Private Practice
Charleston, South Carolina, 29414, United States
Univ of South Carolina School of Medicine
Columbia, South Carolina, 29203, United States
North Texas Center for AIDS & Clinical Research
Dallas, Texas, 75208, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75390, United States
Joseph Gathe
Houston, Texas, 77004, United States
Univ TX Health Science Ctr
Houston, Texas, 77030, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
Wisconsin AIDS Research Consortium
Milwaukee, Wisconsin, 53203, United States
Downtown Infectious Diseases Clinic
Vancouver, British Columbia, Canada
McMaster Univ Med Ctr
Hamilton, Ontario, Canada
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Hospital General De Mexico
Mexico City, Mexico
Hospital Regional
Mexico City, Mexico
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico
Instituto Nacional de la Nutricion
Mexico City, Mexico
Ponce School of Medicine
Ponce, 00732, Puerto Rico
Hepatology / Infectious Diseases
Santruce, 00909, Puerto Rico
Program on AIDS / Thai Red Cross Society
Bangkok, Thailand
Ramathibodi Hosp
Bangkok, Thailand
Siriraj Hosp / Mahidol Univ
Bangkok, Thailand
Khonkaen Univ
Khonkaen, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Giordano
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 10, 2001
First Posted
December 11, 2001
Study Start
August 1, 2001
Primary Completion
April 1, 2002
Study Completion
April 1, 2002
Last Updated
May 4, 2011
Record last verified: 2011-04