Back to resultsA Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor
Primary Purpose
HIV Infections
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atazanavir
Nelfinavir mesylate
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, Reverse Transcriptase Inhibitors, Viral Load, BMS 232632
Eligibility 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.
Sites / Locations
- Health for Life Clinic
- East Bay AIDS Ctr
- Orange County Ctr for Special Immunology
- Tower Infectious Diseases
- Kaiser Hospital
- HIV Institute / Davies Med Ctr
- Kaiser Foundation Hospital
- IDC Research Initiative
- Larry Bush
- Bach and Godofsky
- North Broward Hosp District / HIV Clinical Research
- Gary Richmond MD
- Infectious Diseases Associates
- Daniel Seekins
- Infectious Disease Research Inst
- Philip Brachman
- Med College of Georgia
- Cook County Gen Hosp / Division of Infect Diseases
- Division of Inf Diseases/ Indiana Univ Hosp
- Tulane Univ School of Medicine
- Beth Israel Deaconess Med Ctr
- Community Research Initiative of New England
- CRI - Springfield
- Henry Ford Hosp
- Infectious Disease Clinic
- Washington Univ School of Medicine
- South Jersey Infectious Diseases Inc
- Albert Einstein College of Medicine
- Community Research Initiative on AIDS
- Saint Luke's - Roosevelt Hosp Ctr
- Mount Sinai Med Ctr
- Carolinas Med Ctr
- Piedmont Infectious Disease Consultants
- Jemsek Clinic
- Wake Forest Univ School of Medicine
- Summa Health System
- Associates in Med and Mental Health
- Research & Education Group
- Hahnemann Univ Hosp
- Ludwig Lettau Private Practice
- Univ of South Carolina School of Medicine
- North Texas Center for AIDS & Clinical Research
- Univ of Texas Southwestern Med Ctr
- Joseph Gathe
- Univ TX Health Science Ctr
- Hampton Roads Med Specialists
- Wisconsin AIDS Research Consortium
- Downtown Infectious Diseases Clinic
- McMaster Univ Med Ctr
- Sunnybrook Health Science Ctr
- Clinique Medicale du Quartier Latin
- Clinique Medicale L'Actuele
- Hospital General De Mexico
- Hospital Regional
- Instituto Nacional de Enfermedades Respiratorias
- Instituto Nacional de la Nutricion
- Ponce School of Medicine
- Hepatology / Infectious Diseases
- Program on AIDS / Thai Red Cross Society
- Ramathibodi Hosp
- Siriraj Hosp / Mahidol Univ
- Khonkaen Univ
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00028067
Brief Title
A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Study Start Date
August 2001 (undefined)
Primary Completion Date
April 2002 (Actual)
Study Completion Date
April 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, Reverse Transcriptase Inhibitors, Viral Load, BMS 232632
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atazanavir
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Giordano
Official's Role
Study Director
Facility Information:
Facility Name
Health for Life Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Orange County Ctr for Special Immunology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Tower Infectious Diseases
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Kaiser Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
HIV Institute / Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Kaiser Foundation Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Larry Bush
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Bach and Godofsky
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
North Broward Hosp District / HIV Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Gary Richmond MD
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Infectious Diseases Associates
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Daniel Seekins
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Infectious Disease Research Inst
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Philip Brachman
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Cook County Gen Hosp / Division of Infect Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Division of Inf Diseases/ Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Beth Israel Deaconess Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Community Research Initiative of New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
CRI - Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Infectious Disease Clinic
City
Warren
State/Province
Michigan
ZIP/Postal Code
48089
Country
United States
Facility Name
Washington Univ School of Medicine
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
South Jersey Infectious Diseases Inc
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Community Research Initiative on AIDS
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Carolinas Med Ctr
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232
Country
United States
Facility Name
Piedmont Infectious Disease Consultants
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Jemsek Clinic
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Wake Forest Univ School of Medicine
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Associates in Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Research & Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
Hahnemann Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Ludwig Lettau Private Practice
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Univ of South Carolina School of Medicine
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
North Texas Center for AIDS & Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Joseph Gathe
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Univ TX Health Science Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Wisconsin AIDS Research Consortium
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53203
Country
United States
Facility Name
Downtown Infectious Diseases Clinic
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
McMaster Univ Med Ctr
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Science Ctr
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Clinique Medicale du Quartier Latin
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Clinique Medicale L'Actuele
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hospital General De Mexico
City
Mexico City
Country
Mexico
Facility Name
Hospital Regional
City
Mexico City
Country
Mexico
Facility Name
Instituto Nacional de Enfermedades Respiratorias
City
Mexico City
Country
Mexico
Facility Name
Instituto Nacional de la Nutricion
City
Mexico City
Country
Mexico
Facility Name
Ponce School of Medicine
City
Ponce
ZIP/Postal Code
00732
Country
Puerto Rico
Facility Name
Hepatology / Infectious Diseases
City
Santruce
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Program on AIDS / Thai Red Cross Society
City
Bangkok
Country
Thailand
Facility Name
Ramathibodi Hosp
City
Bangkok
Country
Thailand
Facility Name
Siriraj Hosp / Mahidol Univ
City
Bangkok
Country
Thailand
Facility Name
Khonkaen Univ
City
Khonkaen
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Atazanavir and Nelfinavir, Each in Combination With 2 NRTIs, in Patients Who Have Failed Treatments Without a Protease Inhibitor
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