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NCT00232908

QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

361 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-10-31

Brief Summary

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This study will evaluate patient quality of life and tolerability of a HAART (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use a 31-gauge thin-walled 8mm needle to administer Fuzeon. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

ARV regimen

Intervention Type DRUG

As prescribed

enfuvirtide [Fuzeon]

Intervention Type DRUG

90mg sc bid for 12 weeks

Interventions

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ARV regimen

As prescribed

Intervention Type DRUG

enfuvirtide [Fuzeon]

90mg sc bid for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adults or adolescents at least 16 years of age;
* HIV-1 infection;
* clinically stable, treatment-experienced;
* evidence of HIV-1 replication despite ongoing antiretroviral therapy;
* CD4 + count greater than 50 cells/mm3.

Exclusion Criteria

* previous use of Fuzeon and/or T-1249;
* active, untreated opportunistic infection;
* inability to self-inject, unless a reliable caregiver is available to inject.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Phoenix, Arizona, United States

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Bakersfield, California, United States

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Berkeley, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Modesto, California, United States

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Oakland, California, United States

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Palm Springs, California, United States

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Rancho Mirage, California, United States

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San Mateo, California, United States

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Tarzana, California, United States

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Washington D.C., District of Columbia, United States

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Bay Pines, Florida, United States

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Boynton Beach, Florida, United States

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Brandon, Florida, United States

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Daytona Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Miami Beach, Florida, United States

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North Palm Beach, Florida, United States

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Oakland Park, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Pompano Beach, Florida, United States

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Port Saint Lucie, Florida, United States

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Sarasota, Florida, United States

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South Miami, Florida, United States

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Tallahassee, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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