Fuzeon Viral Decay Pilot Study

What Was Tested

In this not phased trial, researchers set out to test Enfuvirtide.

It had two arms (groups): Did not receive enfuvirtide (placebo comparator) and enfuvirtide (active comparator).

Patients were randomized to either receive enfuviratide or not receive it.

The registry classes the interventions as drug.

Who Took Part

18 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Patient must be HIV infected. Patient must be \> 18 years old. Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years. Patient must have a CD4 count above 400 cells/mm3 in last 3 months. Female patient must agree to use two methods of birth control or abstinence during the period of the study.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: patient who would have difficulty participating in a trial due to non-adherence or substance abuse; patient who have taken mono or dual antiretroviral therapy; patient who have had a viral load \> 50 copies/ml on any antiretroviral regimen.

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.

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.

It started in 2006-02 with completion listed for 2007-07.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6 (time frame: 6 months).

It also tracked 8 secondary outcomes, for example To determine the change of proviral HIV-1 DNA from baseline to month 3, To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm, To quantify plasma HIV (limit of detection 2 copies/ml of plasma), To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells, To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays and To determine the half-life of HIV in resting CD4+ T cells.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Enfuvirtide in 18 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.