Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals

What Was Tested

In this early phase 1 trial, researchers set out to test Enfuvirtide.

To find out if it is possible for HIV-1 patients to maintain antiretroviral medications during allogeneic bone marrow transplant.

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

The registry classes the interventions as drug.

More on the Plan

Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic hematopoietic stem cell transplant (HSCT).

The primary outcome is the fraction of patients who maintain any form of anti-retroviral therapy, including enfuvirtide monotherapy, through day 60 post-transplant.

If patients are unable to take oral anti-retroviral medications, but are able to tolerate subcutaneous enfuvirtide monotherapy this will be considered maintenance of ART.

Failure to maintain ART will be defined as ≥ 24 hours without any anti-retroviral therapy.

Who Took Part

The registry lists 11 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: Patients must be ≥ 18 years of age.

The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: patients with a known history of enfuvirtide resistance will not be eligible for this trial.

How the Study Was Run

The set-up was single-group and open-label.

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 2013-06 with completion listed for 2020-01-22.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic HSCT (time frame: 24 hours).

It also tracked 6 secondary outcomes, for example Number of copies of HIV-1 DNA in blood mononuclear cells at baseline, Number of copies of HIV-1 DNA in blood mononuclear cells at 12 weeks, Number of copies of HIV-1 DNA in blood mononuclear cells at 24 weeks, Number of copies of HIV-1 DNA in blood mononuclear cells at 36 weeks, Number of copies of HIV-1 DNA in blood mononuclear cells at 52 weeks and Number of copies of HIV-1 DNA in blood mononuclear cells at 2 years.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Enfuvirtide in 11 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.