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
Recruitment status was Recruiting
Sponsor:
Aalborg Universityhospital
Information provided by:
Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT00451984
First received: March 23, 2007
Last updated: October 31, 2007
Last verified: October 2007
| Tracking Information | |||||
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| First Received Date ICMJE | March 23, 2007 | ||||
| Last Updated Date | October 31, 2007 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Antibody response to hepatitis A and hepatitis B | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00451984 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hepatitis Vaccination in HIV Infection: Role of Adjuvant Interleukin-2 | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00451984 | ||||
| Other Study ID Numbers ICMJE | VN2005/32 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Aalborg Universityhospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Aalborg Universityhospital | ||||
| Verification Date | October 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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