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Clinical Trials

MainTitle

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

The recruitment status of this study is unknown.

Verified October 2007

Sponsor
Aalborg Universitetshospital


Information provided by (Responsible Party)
Aalborg Universitetshospital
ClinicalTrials.gov Identifier
NCT00451984

First received: March 23, 2007
Last updated: October 31, 2007
Last Verified: October 2007
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections
Hepatitis A
Hepatitis B

Biological : Twinrix
Biological : interleukin-2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Further study details as provided by Aalborg Universitetshospital:

Primary Outcome Measures

  • Antibody response to hepatitis A and hepatitis B

Estimated Enrollment: 80
Study Start Date: March 2007

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

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


Exclusion Criteria:
  • Prior hepatitis A or B

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451984

Contacts

Contact:   Henrik Nielsen, MD, DMSci +45-99326525 henrik.nielsen@rn.dk

Locations

Denmark
Department of Infectious Diseases, Aalborg Hospital Recruiting
Aalborg, Denmark, DK9000
Principal Investigator: Raquel M Iguacel, MD
Sub-Investigator: Henrik Nielsen, MD, DMSci
Department of Infectious Diseases, Skejby Hospital Not yet recruiting
Aarhus, Denmark, DK8200
Contact: Alex Laursen, MD, DMSci    +45-89495566
Principal Investigator: Ole Søgaard, MD

Sponsors and Collaborators

Aalborg Universitetshospital

Investigators

Study Chair: Henrik Nielsen, MD, DMSci Aalborg Hospital, DK-9000 Aalborg, Denmark
More Information

More Information


Responsible Party: Aalborg Universitetshospital  
ClinicalTrials.gov Identifier: NCT00451984   History of Changes  
Other Study ID Numbers: VN2005/32  
Study First Received: March 23, 2007  
Last Updated: October 31, 2007  

Keywords provided by Aalborg Universitetshospital:

interleukin-2
vaccination
treatment experienced

Additional relevant MeSH terms:
Infection
Hepatitis
Hepatitis A
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis B
Interleukin-2

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.