Cohort Study for Patients Using Fuzeon (Enfuvirtide)

NCT00216359 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2005-10-25

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Antiretroviral Treatment

Interventions

DRUG

Fuzeon (Enfuvirtide)

PROCEDURE

Laboratory diagnostic (CD4-cells)

PROCEDURE

Laboratory diagnostics (HIV-1 viral load)

DRUG

antiretroviral co-medication beside Fuzeon

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY
  • Institute for Interdisciplinary Infectiology

    lead OTHER

Principal Investigators

  • Andreas Plettenberg, MD · ifi-Institute for Interdisciplinary Infectiology

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Completion
2006-12-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00216359 on ClinicalTrials.gov