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

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ClinicalTrials.gov Identifier: NCT00451984
Recruitment Status : Unknown
Verified October 2007 by Aalborg Universitetshospital.
Recruitment status was:  Recruiting
First Posted : March 26, 2007
Last Update Posted : November 1, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Hepatitis A Hepatitis B Biological: Twinrix Biological: interleukin-2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Antibody response to hepatitis A and hepatitis B

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00451984     History of Changes
Other Study ID Numbers: VN2005/32
First Posted: March 26, 2007    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: October 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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs