Cohort Study for Patients Using Fuzeon (Enfuvirtide) | NCT00216359

Studies
Cohort Study for Patients Using Fuzeon (Enfuvirtide)

NCT00216359

Sponsor

Institute for Interdisciplinary Infectiology

Status

Unknown status

Last Update Posted

Oct 25, 2005Estimated

Enrollment

200

Phase

Not provided

Conditions

HIV Infections
Antiretroviral Treatment

Interventions

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

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2005

Last Update Posted Date

Oct 25, 2005Estimated

Name	Class
Hoffmann-La Roche	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fuzeon (Enfuvirtide)	Drug
Laboratory diagnostic (CD4-cells)	Procedure
Laboratory diagnostics (HIV-1 viral load)	Procedure
antiretroviral co-medication beside Fuzeon	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Inability to understand or sign inform consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Plettenberg, MD	ifi-Institute for Interdisciplinary Infectiology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ifi-Institute for Interdisciplinary Infectiology		Hamburg		D-20099	Germany

Label	URL
Radata-Homepage (German language)	View source

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077560	Enfuvirtide

Ancestor Terms

ID	Term
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D015700	HIV Envelope Protein gp41

Browse Leaves

Not provided

Browse Branches

Not provided