A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy

What Was Tested

In this phase 4 trial, researchers set out to test Enfuvirtide.

The researchers hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction phase of HAART therapy will lead to faster clearance of virus and infected cells, and lower number of minority variant HIV-1 strains.

It had two arms (groups): Standard Treatment (active comparator) and Standard Treatment Plus Enfuvirtide (experimental).

The registry classes the interventions as drug.

More on the Plan

This is an 48 week Phase 4, open label, randomized, prospective, pilot proof of concept study to evaluate the use of Enfuvirtide in an induction/maintenance treatment model.

Patients meeting inclusion criteria will be stratified into two groups according to HIV-1 RNA viral loads (less than 300,000 copies/ml and greater than 300,000 copies/ml).

Thereafter, patients will be block randomized (the size of each block will be two patients) into one of two treatment arms.

Who Took Part

2 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age: 18 to 70 years of age. Sex: Male or Female. Documented HIV-1 seropositive by Western Blot, Elisa, or HIV-1 viral load. Naïve to HAART. Viral load \>100,000c/ml.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: patients with malabsorption or severe chronic diarrhea for more than 30 days; inability to consume adequate oral intake (defined as inability to eat at least 1 meal per day); current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

How the Study Was Run

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

Because people in this Enfuvirtide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Enfuvirtide group and the comparison group ran side by side rather than switching.

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.

It started in 2005-01 with completion listed for 2007-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to viral suppression below 50c/ml (time frame: Individual).

It also tracked 11 secondary outcomes, for example Development of clinical mutations, Development of sub-clinical mutations (minority variants), Viral suppression (below 50c/ml) at 24 and 48 weeks, Time to loss of viral response. Loss of viral response defined as:, Inability to achieve Viral load <50c/ml by week 12 and Viral load >50c/ml on 2 consecutive measurements taken 2 weeks apart after viral.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Enfuvirtide in 2 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.