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NCT00000901 · ClinicalTrials.gov registry record · Phase 1

Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children

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

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00000901: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000901 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). 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

NCT00000901, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected children. IDV will be given either as a powder mixed into applesauce or as capsules given on an empty stomach.

Interventions

  • DRUG Lamivudine
  • DRUG Indinavir sulfate
  • DRUG Stavudine

Trial Details

FieldValue
Enrollment Target 24 participants
Est. Completion 2000-10
Phase Phase 1

What the finished NCT00000901 record still lists

NCT00000901 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 3 interventions - of which Lamivudine is the first listed.

NCT00000901 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000901 about?

NCT00000901 is a clinical study titled "Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children". The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected children. IDV will be given either as a powder mixed into applesauce or as capsules given on an empty stomach.

What is the current status of trial NCT00000901?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. Estimated completion is 2000-10.

What interventions are being tested in trial NCT00000901?

The interventions under investigation include: Lamivudine (DRUG), Indinavir sulfate (DRUG), Stavudine (DRUG).

Who is sponsoring clinical trial NCT00000901?

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 NCT00000901'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 NCT00000901, the US trial registry maintained by the National Library of Medicine. NCT00000901 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.