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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00002411 |
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).
Condition | Intervention |
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HIV Infections |
Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Didanosine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Principal Investigator: | . . | . |
Study ID Numbers: | 039E, AI454-148 |
Study First Received: | November 2, 1999 |
Last Updated: | August 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00002411 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV-1 Didanosine Drug Therapy, Combination Zidovudine Stavudine |
Lamivudine RNA, Viral Nelfinavir Anti-HIV Agents Viral Load |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Stavudine Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Antiviral Agents |
Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors Virus Diseases Didanosine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Nelfinavir Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Nelfinavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |