A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients

What Was Tested

In this phase 4 trial, researchers set out to test Enfuvirtide.

It had two arms (groups): Phase I (experimental) and Phase II (experimental).

The registry classes the interventions as drug.

Who Took Part

29 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Adult patients, \>=18 years of age. Triple class treatment-experienced, Fuzeon- and integrase-inhibitor naive. GSS \>= 3 ; nucleosides excluded.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: adverse clinical or laboratory experience \>actg grade 4; untreated infection, intercurrent illness, drug toxicity or other condition contraindicating an antiretroviral regimen; malignancy requiring chemotherapy or radiotherapy.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Enfuvirtide and who got the comparison, which limits bias.

The Enfuvirtide group and the comparison group ran side by side rather than switching.

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

It started in 2007-06 with completion listed for 2008-10.

It ran at 43 sites in United States (41) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL (time frame: Between Week I-4 and Week I-12 of Phase I of the study). Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16 (time frame: Week II-16).

It also tracked 5 secondary outcomes, for example Virologic Response Over Time in Phase I of the Study, HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study, Virologic Response Over Time in Phase II of the Study, CD4+ Lymphocyte Count Change From Baseline and Percentage of Patients With Ongoing Injection Site Reactions (ISRs).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Enfuvirtide in 29 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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