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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00232908

Enrollment

361

Registered

2005-10-05

Start date

2004-06-30

Completion date

2005-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

DRUGARV regimen

As prescribed

DRUGenfuvirtide [Fuzeon]

90mg sc bid for 12 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
QoL (MOS-HIV)\n	Baseline and Week 12

Secondary

Measure	Time frame
Change from baseline in HIV-RNA	Week 12
Change from baseline in CD4 count	Week 12

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026