Trial Information

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

Status: Completed

Protocol Number: ML18018

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific 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

Brief Summary: 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. Target sample size is 325.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: HIV Infections

Intervention Type: Drug

Intervention Name: enfuvirtide [Fuzeon]

Primary Outcome: 1. QoL (MOS-HIV) Time frame: Baseline and Week 12

Key Secondary Outcomes: 1. Change from baseline in HIV-RNA Time frame: Week 12 2. Change from baseline in CD4 count Time frame: Week 12

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 16 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/26/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:36:59 PM