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NCT00000913 · ClinicalTrials.gov registry record · Phase 2

A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
50
Enrollment target

NCT00000913: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000913 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000913, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study Summary

The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs. SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors.

Interventions

  • DRUG Ritonavir
  • DRUG Nelfinavir mesylate
  • DRUG Saquinavir

Trial Details

FieldValue
Enrollment Target 50 participants
Est. Completion 2001-04
Phase Phase 2

What the finished NCT00000913 record still lists

NCT00000913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 3 interventions - of which Ritonavir is the first listed.

NCT00000913 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000913 about?

NCT00000913 is a clinical study titled "A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children". The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs. SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is ...

What is the current status of trial NCT00000913?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. Estimated completion is 2001-04.

What interventions are being tested in trial NCT00000913?

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

Who is sponsoring clinical trial NCT00000913?

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 NCT00000913's enrollment target sits among peer trials

50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00000913, the US trial registry maintained by the National Library of Medicine. NCT00000913 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.