A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs
NCT ID: NCT00002411
Last Updated: 2011-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
1998-03-31
1999-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Nelfinavir mesylate
Lamivudine
Stavudine
Zidovudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
Within 15 business days prior to randomization:
* CD4 cell count greater than or equal to 100 cells/mm3.
* HIV RNA greater than or equal to 2,000 copies/ml by Roche Amplicor Assay.
Exclusion Criteria
Patients with any of the following symptoms or conditions are excluded:
* Bilateral peripheral neuropathy.
* Intractable diarrhea.
* Proven or suspected acute hepatitis within 30 days prior to study entry.
Concurrent Medication:
Excluded:
\- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
Concurrent Treatment:
Excluded:
Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
Patients with the following prior conditions are excluded:
History of acute or chronic pancreatitis.
Prior Medication:
Excluded:
* Therapy for any previous disease that may interfere with patient ability to participate in this study.
* Excluded within 14 days prior to randomization:
Greater than 4 weeks of nucleoside therapy or greater than 1 week of protease inhibitor therapy.
* Excluded within 3 months of the start of this study or expected need at time of enrollment:
* Agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatotoxic, or cytotoxic potential.
* Inability to tolerate oral medication.
Prior Treatment:
Excluded:
Therapy for any previous disease that may interfere with patient ability to participate in this study.
Risk Behavior:
Excluded:
Active alcohol or substance abuse that, in the opinion of the investigator, is sufficient to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis.
12 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Locations
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Sorra Research Ctr / Med Forum
Birmingham, Alabama, United States
Body Positive
Phoenix, Arizona, United States
Hill Top Research Inc
Fresno, California, United States
UCLA Med Ctr / CARE BH-412 CHS
Los Angeles, California, United States
AIDS Healthcare Foundation
Los Angeles, California, United States
West Los Angeles VAMC
Los Angeles, California, United States
Sherman Oaks Hosp Research Institute
Sherman Oaks, California, United States
Harbor UCLA Med Ctr / Research and Educational Institute
Torrance, California, United States
Yale New Haven Hosp / Nathan Smith Clinic
New Haven, Connecticut, United States
GW Med Ctr / Clinical Trials Unit
Washington D.C., District of Columbia, United States
Med Alternatives
Fort Lauderdale, Florida, United States
Urgent Care Ctr
Fort Lauderdale, Florida, United States
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, United States
Hillsborough County Health Dept
Tampa, Florida, United States
Saint Josephs Hosp
Tampa, Florida, United States
Northwestern Univ / Div of Infect Diseases
Chicago, Illinois, United States
Rush Presbyterian / ST Lukes Med Ctr
Chicago, Illinois, United States
Univ of Kansas School of Medicine / Office of Rsch
Wichita, Kansas, United States
Ky Clinic Annex #4 / Room 205E / Speed Sort #0284
Lexington, Kentucky, United States
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, United States
NJCRI
Newark, New Jersey, United States
Infectious Disease Assoc of Central Jersey
Somerville, New Jersey, United States
UCT International
Farmingdale, New York, United States
St Luke Roosevelt Hosp
New York, New York, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, United States
SUNY at Stony Brook / Div of Infectious Disease
Stony Brook, New York, United States
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, United States
Stephen P Hauptman
Philadelphia, Pennsylvania, United States
Med Univ of South Carolina / Div of Infect Disease
Charleston, South Carolina, United States
Univ of Texas / Med Branch at Galveston
Galveston, Texas, United States
Joseph C Gathe
Houston, Texas, United States
Countries
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Other Identifiers
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AI454-148
Identifier Type: -
Identifier Source: secondary_id
039E
Identifier Type: -
Identifier Source: org_study_id
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