Cohort Study for Patients Using Fuzeon (Enfuvirtide)

Institute for Interdisciplinary Infectiology

Status: Unknown

Conditions: Antiretroviral Treatment; HIV Infections

Treatments: Drug: antiretroviral co-medication beside Fuzeon; Drug: Fuzeon (Enfuvirtide); Procedure: Laboratory diagnostic (CD4-cells); Procedure: Laboratory diagnostics (HIV-1 viral load)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00216359

Radata Fuzeon Cohort

Details and patient eligibility

About

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.

Sex: All

Volunteers: No 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