NCT00216359

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 25, 2005

Status Verified

September 1, 2005

First QC Date

September 14, 2005

Last Update Submit

October 21, 2005

Conditions

HIV InfectionsAntiretroviral Treatment

Keywords

Treatment Experienced

Interventions

Fuzeon (Enfuvirtide)DRUG
Laboratory diagnostic (CD4-cells)PROCEDURE
Laboratory diagnostics (HIV-1 viral load)PROCEDURE
antiretroviral co-medication beside FuzeonDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability to understand or sign inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ifi-Institute for Interdisciplinary Infectiology

Hamburg, D-20099, Germany

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Peptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsHIV Envelope Protein gp41Viral Fusion ProteinsMembrane Fusion ProteinsMembrane ProteinsProteinsHIV AntigensAntigens, ViralViral Proteinsenv Gene Products, Human Immunodeficiency VirusGene Products, envRetroviridae ProteinsHuman Immunodeficiency Virus ProteinsViral Envelope ProteinsViral Structural ProteinsAntigensBiological Factors

Study Officials

  • Andreas Plettenberg, MD

    ifi-Institute for Interdisciplinary Infectiology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

May 1, 2003

Study Completion

December 1, 2006

Last Updated

October 25, 2005

Record last verified: 2005-09

Locations

DE(1)