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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 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Comparison of Atazanavir and Nelfinavir, Each in Combination with 2 NRTIs, in Patients Who Have Failed Treatments without a Protease Inhibitor conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Comparison of Atazanavir and Nelfinavir, Each in Combination with 2 NRTIs, in Patients Who Have Failed Treatments without a Protease Inhibitor Clinical research trials and A Comparison of Atazanavir and Nelfinavir, Each in Combination with 2 NRTIs, in Patients Who Have Failed Treatments without a Protease Inhibitor healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including 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 Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Comparison of Atazanavir and Nelfinavir, Each in Combination with 2 NRTIs, in Patients Who Have Failed Treatments without a Protease Inhibitor clinical trial. Test subjects typically receive the most effective healthcare possible for their A Comparison of Atazanavir and Nelfinavir, Each in Combination with 2 NRTIs, in Patients Who Have Failed Treatments without a Protease Inhibitor condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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
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:
1. The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections
2. Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 in HIV Infected Patients
3. A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC
4. Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
5. The Effect of Alendronate, Calcium, and Vitamin D on Bone Mineral Density in HIV Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
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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