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

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: enfuvirtide [Fuzeon] Drug: ARV regimen	Phase IV

MedlinePlus related topics:

AIDS AIDS Medicines

ChemIDplus related topics:

Enfuvirtide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	An Open-Label Study of a HAART (Highly Active Antiretroviral Therapy) Regimen Containing Subcutaneous Injection of Fuzeon on Quality of Life in Clinically Stable, Treatment-Experienced Patients With HIV-1 Infection

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

QoL (MOS-HIV) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in HIV-RNA [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Change from baseline in CD4 count [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment:	361
Study Completion Date:	October 2005

Arms	Assigned Interventions
1: Experimental	Drug: enfuvirtide [Fuzeon] 90mg sc bid for 12 weeks Drug: ARV regimen As prescribed

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232908

Show 75 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML18018
First Received:	October 4, 2005
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00232908
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Quality of Life

Retroviridae Infections

Enfuvirtide

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases

Anti-Infective Agents

RNA Virus Infections

Slow Virus Diseases

Anti-HIV Agents

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Infection

Antiviral Agents

Pharmacologic Actions

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00232908