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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 103 participants
Start Date 1997-10
Est. Completion 2002-12
Phase Phase 1

What the finished NCT00000893 record still lists

NCT00000893 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher).

The record links to 0 conditions, and to 2 interventions - of which Efavirenz is the first listed.

NCT00000893 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00000893's enrollment target sits among peer trials

103 541st of 2000 higher than 1,458 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00000893, the US trial registry maintained by the National Library of Medicine. NCT00000893 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.