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NCT00089492 · ClinicalTrials.gov registry record · Phase 2

A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

A Phase 2 study of HIV Infections, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
64
Enrollment target
20
Study locations

NCT00089492 is a Phase 2 study of HIV Infections that has completed, run by Hoffmann-La Roche. The registered enrollment target is 64 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT00089492, a Phase 2 study of HIV Infections, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
64 participants
Enrollment target
20
Study locations

Study Summary

This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions Studied

HIV Infections

Interventions

  • DRUG Optimized Background ARVs
  • DRUG enfuvirtide [Fuzeon]

Study Locations (20)

Florida

  • - Bradenton
  • - Miami
  • - North Miami Beach
  • - Orlando
  • - Sarasota

California

  • - Fountain Valley
  • - Los Angeles
  • - Los Angeles

Pennsylvania

  • - Allentown
  • - Philadelphia
  • - Philadelphia

Alabama

  • - Hobson City

Colorado

  • - Denver

Georgia

  • - Atlanta

Louisiana

  • - New Orleans

Massachusetts

  • - Boston

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2004-07
Est. Completion 2006-06
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT00089492

The ClinicalTrials.gov registry entry for NCT00089492 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (86% 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 2 interventions - of which Optimized Background ARVs is the first listed.

NCT00089492 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, California, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00089492 about?

NCT00089492 is a clinical study titled "A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients". This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by t...

What is the current status of trial NCT00089492?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2004-07. Estimated completion is 2006-06.

What conditions does trial NCT00089492 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00089492?

The interventions under investigation include: Optimized Background ARVs (DRUG), enfuvirtide [Fuzeon] (DRUG).

Who is sponsoring clinical trial NCT00089492?

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

Where is trial NCT00089492 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. 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.