A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

What Was Tested

The trial (phase 2) is built around Enfuvirtide.

Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician.

The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 64 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: HIV-1 infected adults or adolescents \>=16 years of age;. HIV-1 RNA \>=5000 copies/mL;. Prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: history of prior use of fuzeon or t-1249;; female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study;; current severe illness;.

How the Study Was Run

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

Because people in this Enfuvirtide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Enfuvirtide study did not mask who received what.

It started in 2004-07 with completion listed for 2006-06.

It ran at 27 sites in United States (21), Canada (3) and Puerto Rico (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Viral load.\n\n (time frame: Week 48).

It also tracked 2 secondary outcomes, for example CD4 lymphocyte count and AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Enfuvirtide in 64 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.