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NCT00002164 · ClinicalTrials.gov registry record · Phase 1

Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants

A Phase 1 study, sponsored by Agouron Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00002164: Completed Phase 1 study, sponsored by Agouron Pharmaceuticals.

NCT00002164 is a Phase 1 study that has completed, run by Agouron Pharmaceuticals. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00002164, a Phase 1 study, has completed, sponsored by Agouron Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age). An evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard tablet formulation in older children (7 to 13 years of age) will also be conducted.

Interventions

  • DRUG Nelfinavir mesylate

Trial Details

FieldValue
Enrollment Target 24 participants
Phase Phase 1
Agouron Pharmaceuticals

10 total trials

What the finished NCT00002164 record still lists

NCT00002164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 1 intervention - of which Nelfinavir mesylate is the first listed.

NCT00002164 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00002164 about?

NCT00002164 is a clinical study titled "Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants". To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age). An evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard tablet formulation in old...

What is the current status of trial NCT00002164?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants.

What interventions are being tested in trial NCT00002164?

The interventions under investigation include: Nelfinavir mesylate (DRUG).

Who is sponsoring clinical trial NCT00002164?

This trial is sponsored by Agouron Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00002164's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 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 NCT00002164, the US trial registry maintained by the National Library of Medicine. NCT00002164 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.