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

What Was Tested

The trial (phase 4) is built around Enfuvirtide.

This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents.

The anticipated time on study treatment is 3-12 months, and the target sample size is 9 individuals.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 6 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: Adult or adolescent patients greater than (\>)16 years of age. CD4 count less than (\<)350/cubic millimeters (mm\^3). HIV RNA viral load \>10,000 copies per milliliter (copies/mL) while on highly active antiretroviral therapy (HAART). Documented resistance, treatment-limiting toxicity, and/or \>=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: women who are pregnant or breastfeeding;; patients unable to self-inject;; active, untreated opportunistic infection.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Everyone knew when Enfuvirtide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2005-04 with completion listed for 2007-10.

It ran at 1 site in Bulgaria.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of participants who discontinue enfuvirtide due to adverse events\n (time frame: Up to 102 weeks). Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections (time frame: Up to 102 weeks). Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events (time frame: Up to 102 weeks).

It also tracked 2 secondary outcomes, for example Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Enfuvirtide in 6 people.

Its size is small, so on its own it can only give an early look.

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.