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NCT00000893 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
NCT00000893 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 103 participants.
The verdict
NCT00000893, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
Study Summary
Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with NFV. Cohort II: The purpose of this study is to see how safe it is to give EFZ syrup combined with NFV and to measure the levels of EFZ and NFV in the blood. (This purpose reflects a change from the original since there are now 2 different cohorts of patients.) EFZ is an effective anti-HIV medication that easily can be combined with other drugs to treat HIV. This is an early study to determine a safe and effective dose for HIV-positive children. This study also will examine the correct dose of NFV to use in combination with EFZ.
Interventions
- DRUG Efavirenz
- DRUG Nelfinavir mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 1997-10 |
| Est. Completion | 2002-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000893
The ClinicalTrials.gov registry entry for NCT00000893 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Efavirenz is the first listed.
NCT00000893 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000893 about?
NCT00000893 is a clinical study titled "Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children". Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with NFV. Cohort II: The purpose of this study is to see how safe it is to ...
What is the current status of trial NCT00000893?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 1997-10. Estimated completion is 2002-12.
What interventions are being tested in trial NCT00000893?
The interventions under investigation include: Efavirenz (DRUG), Nelfinavir mesylate (DRUG).
Who is sponsoring clinical trial NCT00000893?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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