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

What Was Tested

The trial (phase 4) is built around Enfuvirtide.

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.

It had 1 arm (groups): 1 (experimental).

The registry classes the interventions as drug.

Who Took Part

361 actual participants took part.

It was open to people of any sex aged from 16 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults or adolescents at least 16 years of age;. Clinically stable, treatment-experienced;. Evidence of HIV-1 replication despite ongoing antiretroviral therapy;. CD4 + count greater than 50 cells/mm3.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: previous use of fuzeon and/or t-1249;; active, untreated opportunistic infection;; inability to self-inject, unless a reliable caregiver is available to inject.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Nothing was hidden in this open-label Enfuvirtide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2004-06 with completion listed for 2005-10.

It ran at 106 sites in United States (103) and Puerto Rico (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: QoL (MOS-HIV)\n (time frame: Baseline and Week 12).

It also tracked 2 secondary outcomes, for example Change from baseline in HIV-RNA and Change from baseline in CD4 count.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Enfuvirtide in 361 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Enfuvirtide compound page, all human trials.