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NCT00038480 · ClinicalTrials.gov registry record · Phase 1

Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants

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

Completed
Registry status
Phase 1
Development phase
31
Enrollment target

NCT00038480: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00038480 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00038480, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
31 participants
Enrollment target

Study Summary

The purpose of this study is to find out if the drug lopinavir/ritonavir (LPV/RTV) is safe and well tolerated in HIV infected infants. This study will also determine the most effective dose of LPV/RTV for infants.

Interventions

  • DRUG Lopinavir/Ritonavir

Trial Details

FieldValue
Enrollment Target 31 participants
Est. Completion 2007-09
Phase Phase 1

What the finished NCT00038480 record still lists

NCT00038480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 1 intervention - of which Lopinavir/Ritonavir is the first listed.

NCT00038480 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00038480 about?

NCT00038480 is a clinical study titled "Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants". The purpose of this study is to find out if the drug lopinavir/ritonavir (LPV/RTV) is safe and well tolerated in HIV infected infants. This study will also determine the most effective dose of LPV/RTV for infants.

What is the current status of trial NCT00038480?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. Estimated completion is 2007-09.

What interventions are being tested in trial NCT00038480?

The interventions under investigation include: Lopinavir/Ritonavir (DRUG).

Who is sponsoring clinical trial NCT00038480?

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 NCT00038480's enrollment target sits among peer trials

31 1322nd of 2000 higher than 669 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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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT00038480, the US trial registry maintained by the National Library of Medicine. NCT00038480 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.