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



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

For Condition: HIV Infections
Status: Terminated
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: The purpose of this study is to compare the atazanavir and nelfinavir (NFV) treatments in their ability to reduce viral load.
Details: 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:
Study Type:
  Interventional, Treatment, Active Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 500

Location and Contact Information:

Overall Study Official:
MichaelGiordano,  Study Director, 

Hahnemann Univ Hosp
Philadelphia,  Pennsylvania,  19102
United States
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

Larry Bush
Atlantis,  Florida,  33462
United States
 

CRI - Springfield
Springfield,  Massachusetts,  01107
United States
 

Albert Einstein College of Medicine
Bronx,  New York,  10461
United States
 

Daniel Seekins
Tampa,  Florida,  33607
United States
 

Carolinas Med Ctr
Charlotte,  North Carolina,  28232
United States
 

Instituto Nacional de la Nutricion
Mexico City,  , 
Mexico
 

Ponce School of Medicine
Ponce,  ,  00732
Puerto Rico
 

South Jersey Infectious Diseases Inc
Somers Point,  New Jersey,  08244
United States
 

Sunnybrook Health Science Ctr
Toronto,  Ontario, 
Canada
 

Henry Ford Hosp
Detroit,  Michigan,  48202
United States
 

Downtown Infectious Diseases Clinic
Vancouver,  British Columbia, 
Canada
 

Infectious Disease Clinic
Warren,  Michigan,  48089
United States
 

Univ of South Carolina School of Medicine
Columbia,  South Carolina,  29203
United States
 

Univ of Texas Southwestern Med Ctr
Dallas,  Texas,  75390
United States
 

Med College of Georgia
Augusta,  Georgia,  30912
United States
 

Jemsek Clinic
Huntersville,  North Carolina,  28078
United States
 

East Bay AIDS Ctr
Berkeley,  California,  94705
United States
 

Hospital General De Mexico
Mexico City,  , 
Mexico
 

Siriraj Hosp / Mahidol Univ
Bangkok,  , 
Thailand
 

Summa Health System
Akron,  Ohio,  44304
United States
 

Tulane Univ School of Medicine
New Orleans,  Louisiana,  70112
United States
 

Clinique Medicale du Quartier Latin
Montreal,  Quebec, 
Canada
 

Clinique Medicale L'Actuele
Montreal,  Quebec, 
Canada
 

Washington Univ School of Medicine
St. Louis,  Missouri,  63108
United States
 

Univ TX Health Science Ctr
Houston,  Texas,  77030
United States
 

Orange County Ctr for Special Immunology
Fountain Valley,  California,  92708
United States
 

Khonkaen Univ
Khonkaen,  , 
Thailand
 

IDC Research Initiative
Altamonte Springs,  Florida,  32701
United States
 

Kaiser Hospital
Sacramento,  California,  95825
United States
 

Community Research Initiative on AIDS
New York City,  New York,  10018
United States
 

Hepatology / Infectious Diseases
Santruce,  ,  00909
Puerto Rico
 

Joseph Gathe
Houston,  Texas,  77004
United States
 

McMaster Univ Med Ctr
Hamilton,  Ontario, 
Canada
 

Gary Richmond MD
Ft. Lauderdale,  Florida,  33316
United States
 

Beth Israel Deaconess Med Ctr
Boston,  Massachusetts,  02215
United States
 

Ludwig Lettau Private Practice
Charleston,  South Carolina,  29414
United States
 

Kaiser Foundation Hospital
San Francisco,  California,  94118
United States
 

Associates in Med and Mental Health
Tulsa,  Oklahoma,  74114
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
 

Health for Life Clinic
Little Rock,  Arkansas,  72205
United States
 

HIV Institute / Davies Med Ctr
San Francisco,  California,  94114
United States
 

Instituto Nacional de Enfermedades Respiratorias
Mexico City,  , 
Mexico
 

Infectious Diseases Associates
Sarasota,  Florida,  34239
United States
 

Community Research Initiative of New England
Brookline,  Massachusetts,  02445
United States
 

Bach and Godofsky
Bradenton,  Florida,  34205
United States
 

Hospital Regional
Mexico City,  , 
Mexico
 

Ramathibodi Hosp
Bangkok,  , 
Thailand
 

Hampton Roads Med Specialists
Hampton,  Virginia,  23666
United States
 

Piedmont Infectious Disease Consultants
Hickory,  North Carolina,  28602
United States
 

Wake Forest Univ School of Medicine
Winston Salem,  North Carolina,  27157
United States
 

Tower Infectious Diseases
Los Angeles,  California,  90048
United States
 

Philip Brachman
Atlanta,  Georgia,  30309
United States
 

North Broward Hosp District / HIV Clinical Research
Ft. Lauderdale,  Florida,  33311
United States
 

Saint Luke's - Roosevelt Hosp Ctr
New York City,  New York,  10019
United States
 

Program on AIDS / Thai Red Cross Society
Bangkok,  , 
Thailand
 

North Texas Center for AIDS & Clinical Research
Dallas,  Texas,  75208
United States
 

Wisconsin AIDS Research Consortium
Milwaukee,  Wisconsin,  53203
United States
 

Infectious Disease Research Inst
Tampa,  Florida,  33614
United States
 

Research & Education Group
Portland,  Oregon,  97209
United States
 


Additional Information:
Study ID Numbers:
  302F;  AI424-037
Study Start Date: August 2001
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028067

Other Hiv Infections Studies:
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2. A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection

3. A Test of Behavioral Intervention for Women at High Risk for HIV Infection

4. Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune System's Response to HIV

5. A Study of Mitoguazone Dihydrochloride in Patients with AIDS-Related Non-Hodgkin's Lymphoma

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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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