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A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs

This study has been completed.
Study NCT00002411.   Last updated on August 15, 2007.   Information provided by Bristol-Myers Squibb

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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).

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
MEDLINE PMIDs
Links BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site
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:

  • 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

Co-existing Condition:

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.

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 
Principal Investigator:     . .     .    
Information Provided By Bristol-Myers Squibb
Verification Date August 2007
First Received Date  November 2, 1999
Last Updated Date August 15, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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