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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Aalborg Universityhospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT00451984
First received: March 23, 2007
Last updated: October 31, 2007
Last verified: October 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Antibody response to hepatitis A and hepatitis B

Estimated Enrollment: 80
Study Start Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 Universityhospital
Investigators
Study Chair: Henrik Nielsen, MD, DMSci Aalborg Hospital, DK-9000 Aalborg, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00451984     History of Changes
Other Study ID Numbers: VN2005/32
Study First Received: March 23, 2007
Last Updated: October 31, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Aalborg Universityhospital:
interleukin-2
vaccination
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis B
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
 Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 28, 2013