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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232908
• Other study ID #: ML18018
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2005
• Last updated: November 1, 2016
• Start date: June 2004
• Est. completion date: October 2005

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infection

Intervention

Drug:
• ARV regimen
As prescribed
• enfuvirtide [Fuzeon]
90mg sc bid for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoL (MOS-HIV)\n		Baseline and Week 12	No
Secondary	Change from baseline in HIV-RNA		Week 12	No
Secondary	Change from baseline in CD4 count		Week 12	No