Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults

What Was Tested

The trial (not phased) is built around Enfuvirtide.

HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells.

Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor.

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

The registry classes the interventions as drug.

More on the Plan

A possible explanation for this failure is the persistence of virus in long-lived reservoirs.

Resting memory CD4 cells have been proposed as providing a cellular reservoir.

Addition of the fusion inhibitor T-20 to ART including reverse transcriptase inhibitors and protease inhibitors (PIs) may help achieve this goal.

This study will evaluate whether treatment naive, chronically infected HIV patients treated with T-20 plus emtricitabine (FTC), ritonavir (RTV), saquinavir (SQV), and tenofovir disoproxil fumarate (TDF) have a measurable decline in the latently infected CD4 cell reservoir.

Who Took Part

19 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: Viral load of 1,000 copies/ml or greater within 60 days prior to study entry. CD4 count of 100 cells/mm3 or greater within 60 days prior to study entry. Willing to use acceptable methods of contraception.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: previous treatment with any nucleoside analogue, nonnucleoside reverse transcriptase inhibitor, or fusion inhibitor for longer than 7 days; any previous treatment with t-20, lamivudine, or ftc; HIV-related vaccine within 6 months prior to study entry.

How the Study Was Run

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

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 2003-10 with completion listed for 2007-12.

It ran at 7 sites in United States (6) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 12 secondary outcomes, for example - Level of HIV-1 DNA in PBMC, - Frequency of 2-LTR in PBMC, -Sequence of HIV env and HIV pol genes, -CD8/CD38 antibody binding capacity (ABC), - Level of HIV-1 RNA in cerebrospinal fluid and - Level of HIV-1 RNA in genital fluid.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Enfuvirtide in 19 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.