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