Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 Identifier:
First received: March 23, 2007
Last updated: October 31, 2007
Last verified: October 2007

March 23, 2007
October 31, 2007
March 2007
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Antibody response to hepatitis A and hepatitis B
Same as current
Complete list of historical versions of study NCT00451984 on Archive Site
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Hepatitis Vaccination in HIV Infection: Role of Adjuvant Interleukin-2
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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.

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Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infections
  • Hepatitis A
  • Hepatitis B
  • Biological: Twinrix
  • Biological: interleukin-2
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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Inclusion Criteria:

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

Exclusion Criteria:

  • Prior hepatitis A or B
18 Years and older
Contact: Henrik Nielsen, MD, DMSci +45-99326525
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Aalborg Universitetshospital
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Study Chair: Henrik Nielsen, MD, DMSci Aalborg Hospital, DK-9000 Aalborg, Denmark
Aalborg Universitetshospital
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP