Optimizing Treatment for Treatment-Experienced, HIV-Infected People

What Was Tested

In this phase 3 trial, researchers set out to test Enfuvirtide.

Long-term control of HIV requires at least two anti-HIV drugs that are active against the virus.

Drug resistance is a problem for many treatment-experienced, HIV-infected people.

It had three arms (groups): A (experimental), B (experimental) and C (other).

Regimen with higher predicted activity assigned by the study plus at least 2 NRTIs (personalized choice from expert recommendation) for 96 weeks. A 3-4 drug regimen was selected from the drugs listed to the right.

Regimen with higher predicted activity assigned by the study without NRTIs for 96 weeks. A 3-4 drug regimen was selected from the drugs listed to the right.

Regimen with lower predicted activity assigned plus at least 2 NRTIs (personalized choice from expert recommendation) for 96 weeks. A 3-4 drug regimen was selected from the drugs listed to the right.

The registry classes the interventions as drug.

More on the Plan

Two or more fully active antiretrovirals (ARVs) are recommended for successful suppression of HIV.

In people infected with resistant HIV virus, finding two drugs that are fully active against HIV can be a challenge.

However, the new generation of anti-HIV drugs has been designed to suppress drug-resistant HIV.

These drugs include the FDA-approved protease inhibitors (PIs) darunavir and tipranavir, the investigational non-nucleoside transcriptase inhibitor (nNRTI) etravirine, the FDA-approved fusion inhibitor enfuvirtide, the recently FDA-approved CCR5 inhibitor maraviroc, and the investigational integrase inhibitor raltegravir.

Who Took Part

517 actual participants took part.

It was open to people of any sex aged from 16 years with no upper age limit.

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

Examples of who could join: Triple-class drug experience or resistance. More information on this criterion can be found in the protocol. HIV viral load of 1000 copies/ml or more. Hepatitis B surface antigen negative within 90 days of study entry. Able to obtain NRTIs and ritonavir and have required ARVs at time of starting study intervention. Willing to use acceptable forms of contraception.

The full record lists 13 inclusion and 8 exclusion criteria; among the exclusions: chronic, active hepatitis b virus infection (hepatitis b surface antigen positive or hbv dna positive); taking certain medications. more information on this criterion can be found in the protocol; active drug or alcohol use that, in the opinion of the investigator, may interfere with the study.

How the Study Was Run

The set-up was 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2008-01 with completion listed for 2012-05.

It ran at 64 sites in United States (61) and Puerto Rico (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent of Participants With Regimen Failure, Defined as a Confirmed Virologic Failure or Discontinuation of Randomized NRTI Component of Study Treatment (time frame: From study entry to end of Week 48 evaluation window).

It also tracked 14 secondary outcomes, for example Time From Treatment Dispensation to First Study ARV Modification (Excluding NRTIs, if Applicable), Time From Randomization to Discontinuation of Randomized NRTI Component of Study Treatment, Time From Randomization to Confirmed Virological Failure, Number of Participants With Plasma HIV-1 Viral Load < 50 Copies/ml, Change in Plasma HIV-1 Viral Load From Baseline to Week 1 and Change in Summarized Quality of Life Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Enfuvirtide in 517 people.

With 517 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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