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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00232908
First received: October 4, 2005
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: enfuvirtide [Fuzeon]
Drug: ARV regimen
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: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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: July 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014