Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus

What Was Tested

This registered not phased trial tested Enfuvirtide.

Drug resistance may develop in HIV infected patients who take anti-HIV drugs, but most patients do well if they continue taking them.

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

Participants will receive enfuvirtide for 6 months.

The registry classes the interventions as drug.

More on the Plan

While an HIV infected patient is taking highly active antiretroviral therapy (HAART), drug-resistant HIV may emerge; however, it has been observed that HIV viral loads while on HAART are usually lower than baseline levels.

Expansion of the T cell population during early HAART may explain this phenomenon.

It is hoped that a short but aggressive HAART regimen to treatment-experienced patients who have drug-resistant virus will produce immune cells that will better control drug-resistant virus.

This study will last 48 weeks.

Who Took Part

The registry lists 20 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: HIV viral load of more than 1000 copies/ml. On stable antiretroviral therapy. Have multidrug resistance.

The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: require immunomodulatory drugs.

How the Study Was Run

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

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

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

It started in 2003-03 with completion listed for 2005-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HIV viral load (time frame: Throughout study).

It also tracked 1 secondary outcome, for example Frequency of HIV-specific T cells.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Enfuvirtide in 20 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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