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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 | Clinical Trials | Clareo Health

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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 II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Enfuvirtide Dosing Versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment-experienced Patients.

NCT00089492•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•HIV-1 infected adults or adolescents \>=16 years of age;
•HIV-1 RNA \>=5000 copies/mL;
•prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).

Exclusion Criteria

•history of prior use of Fuzeon or T-1249;
•female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study;
•current severe illness;
•currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.

Locations (27)

Hobson City, Alabama, United States

Fountain Valley, California, United States

Los Angeles, California, United States

Denver, Colorado, United States

Bradenton, Florida, United States

Miami, Florida, United States

North Miami Beach, Florida, United States

Orlando, Florida, United States

Sarasota, Florida, United States

Key Dates

Start Date

July 1, 2004

Primary Completion Date

June 1, 2006

Completion Date

June 1, 2006

Last Updated

November 2, 2016

Enrollment

ACTUAL participants

Conditions

HIV Infections

Interventions

Optimized Background ARVs

DRUG

enfuvirtide [Fuzeon]

DRUG

enfuvirtide [Fuzeon]

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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