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: September 22, 2014
Last verified: September 2014

October 4, 2005
September 22, 2014
June 2004
October 2005   (final data collection date for primary outcome measure)
QoL (MOS-HIV)\n [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00232908 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: ARV regimen
    As prescribed
  • Drug: enfuvirtide [Fuzeon]
    90mg sc bid for 12 weeks
Experimental: 1
Interventions:
  • Drug: ARV regimen
  • Drug: enfuvirtide [Fuzeon]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
361
October 2005
October 2005   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00232908
ML18018
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP