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NCT00002383 · ClinicalTrials.gov registry record · Phase 1

A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients

A Phase 1 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
80
Enrollment target

NCT00002383: Completed Phase 1 study, sponsored by Hoffmann-La Roche.

NCT00002383 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00002383, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
80 participants
Enrollment target

Study Summary

To compare the antiviral activity, safety, and pharmacokinetics of saquinavir hard gel capsule (HGC) formulation, to 1 of 3 doses of saquinavir soft gel capsule (SGC) formulation administered orally every 8 hours for 4 weeks.

Interventions

  • DRUG Saquinavir

Trial Details

FieldValue
Enrollment Target 80 participants
Phase Phase 1
Hoffmann-La Roche

909 total trials

What the finished NCT00002383 record still lists

NCT00002383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).

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

NCT00002383 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00002383 about?

NCT00002383 is a clinical study titled "A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients". To compare the antiviral activity, safety, and pharmacokinetics of saquinavir hard gel capsule (HGC) formulation, to 1 of 3 doses of saquinavir soft gel capsule (SGC) formulation administered orally every 8 hours for 4 weeks.

What is the current status of trial NCT00002383?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants.

What interventions are being tested in trial NCT00002383?

The interventions under investigation include: Saquinavir (DRUG).

Who is sponsoring clinical trial NCT00002383?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00002383's enrollment target sits among peer trials

80 672nd of 2000 higher than 1,305 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 NCT00002383, the US trial registry maintained by the National Library of Medicine. NCT00002383 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.