BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.

What Was Tested

The trial (phase 4) is built around Enfuvirtide.

The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled.

The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.

It had 1 arm (groups): Enfuvirtide+PI+ARV's (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 142 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: Adult patients, \>=18 years of age;. Seropositive for HIV-1;. Enrolled in an early access program for a new investigational PI;. Naive to Fuzeon, and the investigational PI;. Treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: females who are pregnant or breast-feeding;; evidence of active, untreated opportunistic infection;; malignancy requiring chemotherapy or radiotherapy.

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 2006-03 with completion listed for 2007-04.

It ran at 38 sites in United States (32) and Australia (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL (time frame: Week 24). Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL (time frame: Week 24).

It also tracked 15 secondary outcomes, for example Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL, Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL, Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL, Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL, Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load and Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Enfuvirtide in 142 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.