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NCT00002178 · ClinicalTrials.gov registry record · Phase 3

A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients

A Phase 3 study of HIV Infections, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
375
Enrollment target
2
Study locations

NCT00002178 is a Phase 3 study of HIV Infections that has completed, run by Hoffmann-La Roche. The registered enrollment target is 375 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (16% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00002178, a Phase 3 study of HIV Infections, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
375 participants
Enrollment target
2
Study locations

Study Summary

To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment. To collect safety data on the treatment regimens. To determine the percentage of patients without SQV soft gel capsules resistance-associated mutations at week 24.

Conditions Studied

Interventions

  • DRUG Ritonavir
  • DRUG Nelfinavir mesylate
  • DRUG Delavirdine mesylate
  • DRUG Saquinavir

Study Locations (2)

California

  • Dr Charles Farthing - Los Angeles

Massachusetts

  • Community Research Initiative - Brookline

Trial Details

FieldValue
Enrollment Target 375 participants
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT00002178

The ClinicalTrials.gov registry entry for NCT00002178 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 375 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (16% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Ritonavir is the first listed.

NCT00002178 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00002178 about?

NCT00002178 is a clinical study titled "A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients". To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment. To collect safety...

What is the current status of trial NCT00002178?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 375 participants.

What conditions does trial NCT00002178 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00002178?

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

Who is sponsoring clinical trial NCT00002178?

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

Where is trial NCT00002178 being conducted?

This trial has 2 study locations across California, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.