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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2007 by Aalborg Universitetshospital.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Aalborg Universitetshospital

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 Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A

U.S. FDA Resources

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


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

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


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 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

ClinicalTrials.gov processed this record on June 27, 2017

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