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

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. According to ClinicalTrials.gov, the official US trial registry.

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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

HIV Infections

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
Hoffmann-La Roche

909 total trials

What the finished NCT00002178 record still lists

NCT00002178 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (16% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00002178's enrollment target sits among peer trials

375 89th of 542 higher than 454 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections 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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Related registry views

Source: ClinicalTrials.gov NCT00002178, the US trial registry maintained by the National Library of Medicine. NCT00002178 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.