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 Universitetshospital.
Recruitment status was  Recruiting
Information provided by:
Aalborg Universitetshospital
ClinicalTrials.gov Identifier:
First received: March 23, 2007
Last updated: October 31, 2007
Last verified: October 2007
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:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior hepatitis A or B
  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

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

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
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 
Study First Received: March 23, 2007
Last Updated: October 31, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Aalborg Universitetshospital:
treatment experienced

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

ClinicalTrials.gov processed this record on May 25, 2016