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Hepatitis Vaccination in HIV Infection: Role of Adjuvant Interleukin-2

NCT ID: NCT00451984

Last Updated: 2007-11-01

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

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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The response to vaccination for hepatitis is reduced in patients with HIV infection. The hypothesis of the study is that adjuvant interleukin-2 administered subcutaneously at the time of vaccination improves the response rate.

Detailed Description

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Conditions

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HIV Infections Hepatitis A Hepatitis B

Keywords

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interleukin-2 vaccination treatment experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Twinrix

Intervention Type BIOLOGICAL

interleukin-2

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults with stable antiretroviral therapy and negative for hepatitis A or B

Exclusion Criteria

* Prior hepatitis A or B
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Henrik Nielsen, MD, DMSci

Role: STUDY_CHAIR

Aalborg Hospital, DK-9000 Aalborg, Denmark

Locations

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Department of Infectious Diseases, Aalborg Hospital

Aalborg, , Denmark

Site Status RECRUITING

Department of Infectious Diseases, Skejby Hospital

Aarhus, , Denmark

Site Status NOT_YET_RECRUITING

Countries

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Denmark

Central Contacts

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Henrik Nielsen, MD, DMSci

Role: CONTACT

Phone: +45-99326525

Email: [email protected]

Facility Contacts

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Alex Laursen, MD, DMSci

Role: primary

Other Identifiers

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VN2005/32

Identifier Type: -

Identifier Source: org_study_id