Cohort Study for Patients Using Fuzeon (Enfuvirtide)

The Radata-Fuzeon Cohort - An Observational Cohort-Study in HIV-Infected Patients Using Fuzeon (Enfuvirtide) as Part of Their Antiretroviral Combination Therapy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00216359

Enrollment

200

Registered

2005-09-22

Start date

2003-05-31

Completion date

2006-12-31

Last updated

2005-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiretroviral Treatment, HIV Infections

Keywords

Treatment Experienced

Brief summary

The Radata-Fuzeon cohort is an observational cohort study to gain a better understanding of Fuzeon (Enfuvirtide) in daily clinical practice. Patients planned to take this drug in a new antiretroviral combination therapy (ART) are eligible to participate in this observation. Physicians may register patients online via the internet. They are offered to get an expert advice suggesting therapeutics for a new ART. Observation interval is every three month. However physicians are allowed to initiate new diagnostics, expert advice and therapeutic changes independently from these intervals if necessary. Total observation time for each patients is planned for two years.

Interventions

DRUGFuzeon (Enfuvirtide)

PROCEDURELaboratory diagnostic (CD4-cells)

PROCEDURELaboratory diagnostics (HIV-1 viral load)

DRUGantiretroviral co-medication beside Fuzeon

Study design

Observational model

NATURAL_HISTORY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of HIV-Infection * Planned to switch to a Fuzeon-containing antiretroviral therapy

Exclusion criteria

* Inability to understand or sign inform consent

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026