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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: October 4, 2005
Last updated: May 4, 2016
Last verified: May 2016
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: ARV regimen
Drug: enfuvirtide [Fuzeon]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • QoL (MOS-HIV)\n [ 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 Start Date: June 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ARV regimen
As prescribed
Drug: enfuvirtide [Fuzeon]
90mg sc bid for 12 weeks


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

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

  Show 106 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00232908     History of Changes
Other Study ID Numbers: ML18018 
Study First Received: October 4, 2005
Last Updated: May 4, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Viral Fusion Protein Inhibitors

ClinicalTrials.gov processed this record on May 30, 2016