A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience

What Was Tested

The trial (phase 4) is built around Enfuvirtide.

It had two arms (groups): ENF + HAART (experimental) and HAART (active comparator).

Participants received an oral highly active antiretroviral treatment (HAART) regimen, consisting of 3-5 antivirals for up to 48 weeks.

The registry classes the interventions as drug.

More on the Plan

This study consisted of two phases.

Participants who achieved viral suppression \< 50 copies/mL by week 24, confirmed by week 28 or earlier, qualified to enter the Maintenance Phase which started at Baseline 2 (BL2), four weeks after confirmation of response.

The Maintenance Phase consisted of three treatment groups: * M1: HAART continued (patients from I1) Patients on ENF+HAART (I2) were re-randomized (at a 1:1 ratio) at BL2 to: * M2: Enfuvirtide stopped and HAART continued * M3: Enfuvirtide + HAART continued.

The duration of the Maintenance Phase was from BL2 up to 48 weeks after BL1.

Who Took Part

47 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-1 infected adults \>=18 years of age;. Currently on antiretroviral (ARV) therapy;. Previously treated with 2 or 3 different antiretroviral classes;. HIV-1 Ribonucleic acid (RNA) \>=1,000 copies/mL;. Cluster differentiation antigen four (CD4) lymphocyte count \>=200 cells/mm\^3;.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: history of prior use of enfuvirtide or t-1249;; women who are pregnant, breastfeeding or planning to become pregnant during the study;; active, untreated opportunistic infection;.

How the Study Was Run

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

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 2005-11 with completion listed for 2007-11.

It ran at 39 sites in Spain (14), Italy (7), France (5), Germany (4), United States (3) and Netherlands (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase (time frame: From Baseline 1 to Week 28).

It also tracked 13 secondary outcomes, for example Time to Achieving HIV-1 RNA < 50 Copies/mL During the Induction Phase, Number of Participants With Viral Suppression HIV-1 RNA < 400 Copies/mL During the Induction Phase, Change From Baseline to Week 24 in Viral Load, Change From Baseline to Week 24 in Cluster Differentiation Antigen Four Positive (CD4+) Cell Counts, Percentage of Induction Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks and Percentage of Maintenance Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Enfuvirtide in 47 people.

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.