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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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Atazanavir (Drug); Nelfinavir mesylate (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Michael Giordano, Study Director


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

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: 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.


Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

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

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

Downtown Infectious Diseases Clinic, Vancouver, British Columbia, Canada

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

Gary Richmond MD, Fort Lauderdale, Florida 33316, United States

North Broward Hosp District / HIV Clinical Research, Fort Lauderdale, Florida 33311, 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

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

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

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

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

McMaster Univ Med Ctr, Hamilton, Ontario, Canada

Sunnybrook Health Science Ctr, Toronto, Ontario, Canada

Research & Education Group, Portland, Oregon 97209, United States

Hahnemann Univ Hosp, Philadelphia, Pennsylvania 19102, United States

Clinique Medicale du Quartier Latin, Montreal, Quebec, Canada

Clinique Medicale L'Actuele, Montreal, Quebec, Canada

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

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: August 2001
Last updated: April 28, 2011

Page last updated: August 23, 2015

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