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A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
Plain-language guide to NCT02582983: phase 4 interventional trial of Enfuvirtide, 23 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02582983
- Phase
- phase 4
- Status
- completed
- Start
- 2004-02
- Completion (planned or actual)
- 2009-12
- Participants
- 23 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- HIV Infections
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Enfuvirtide.
This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease.
The anticipated time on study treatment was based on the commercial availability of enfuvirtide in Thailand, and the target sample size was 30 individuals.
It had 1 arm (groups): Enfuvirtide (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 23 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: Individuals at least 16 years of age infected with HIV-1. Genotypic or phenotypic resistance and/or treatment-limiting toxicity on previous antiretroviral regimens.
The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: evidence of ongoing alcohol and/or drug or substance abuse; prior non-adherence to antiretroviral treatment regimens; evidence of active, untreated opportunistic infection, intercurrent illness, drug toxicity or any other condition.
How the Study Was Run
Design: 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 2004-02 with completion listed for 2009-12.
It ran at 5 sites in Thailand (5).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Number of Participants With Serious Adverse Events (SAEs) (time frame: Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)). Number of Participants With Premature Withdrawal Due to Adverse Events (time frame: Up to 96 weeks).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Enfuvirtide in 23 people.
Its size is small, so on its own it can only give an early look.
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.
Our Notes on the Compound
Enfuvirtide: A 36-amino-acid peptide (Fuzeon) that blocks HIV from entering cells.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.