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| Descriptive Information Fields | |||||
| Brief Title † | A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs | ||||
| Official Title † | A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects | ||||
| Brief Summary | The purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines how long these drug combinations are effective in lowering viral load (level of HIV in the blood). |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | HIV Infections | ||||
| Intervention † | Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Didanosine |
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| MEDLINE PMIDs | |||||
| Links | BMS Clinical Trials Disclosure ![]() For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | March 1998 | ||||
| Completion Date | March 1998 | ||||
| Eligibility Criteria † | Inclusion Criteria Patients must have: Within 15 business days prior to randomization:
Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded:
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:
Greater than 4 weeks of nucleoside therapy or greater than 1 week of protease inhibitor therapy.
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. |
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00002411 | ||||
| Organization ID | 039E | ||||
| Secondary IDs †† | AI454-148 | ||||
| Study Sponsor † | Bristol-Myers Squibb | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Bristol-Myers Squibb | ||||
| Verification Date | August 2007 | ||||
| First Received Date † | November 2, 1999 | ||||
| Last Updated Date | August 15, 2007 | ||||