Cohort Study for Patients Using Fuzeon (Enfuvirtide)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections Antiretroviral Treatment

Keywords

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Treatment Experienced

Study Design

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Observational Model Type

NATURAL_HISTORY

Study Time Perspective

OTHER

Interventions

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Fuzeon (Enfuvirtide)

Intervention Type DRUG

Laboratory diagnostic (CD4-cells)

Intervention Type PROCEDURE

Laboratory diagnostics (HIV-1 viral load)

Intervention Type PROCEDURE

antiretroviral co-medication beside Fuzeon

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Inability to understand or sign inform consent

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Andreas Plettenberg, MD

Role: STUDY_CHAIR

ifi-Institute for Interdisciplinary Infectiology

Locations

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Ifi-Institute for Interdisciplinary Infectiology

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Radata Fuzeon Cohort

Identifier Type: -

Identifier Source: org_study_id