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

Primary Purpose

HIV Infections, Hepatitis A, Hepatitis B

Status

Unknown status

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Twinrix

interleukin-2

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring interleukin-2, vaccination, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Prior hepatitis A or B

Sites / Locations

Department of Infectious Diseases, Aalborg HospitalRecruiting
Department of Infectious Diseases, Skejby Hospital

Outcomes

Primary Outcome Measures

Antibody response to hepatitis A and hepatitis B

Secondary Outcome Measures

Full Information

NCT ID

NCT00451984

First Posted

March 23, 2007

Last Updated

October 31, 2007

Sponsor

Aalborg University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00451984

Brief Title

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

Acronym

HEPVACHIV

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Aalborg University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Hepatitis A, Hepatitis B

Keywords

interleukin-2, vaccination, treatment experienced

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Twinrix

Intervention Type

Biological

Intervention Name(s)

interleukin-2

Primary Outcome Measure Information:

Title

Antibody response to hepatitis A and hepatitis B

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults with stable antiretroviral therapy and negative for hepatitis A or B Exclusion Criteria: Prior hepatitis A or B

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Henrik Nielsen, MD, DMSci

Phone

+45-99326525

henrik.nielsen@rn.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henrik Nielsen, MD, DMSci

Organizational Affiliation

Aalborg Hospital, DK-9000 Aalborg, Denmark

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Infectious Diseases, Aalborg Hospital

City

Aalborg

ZIP/Postal Code

DK9000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raquel M Iguacel, MD

First Name & Middle Initial & Last Name & Degree

Henrik Nielsen, MD, DMSci

Facility Name

Department of Infectious Diseases, Skejby Hospital

City

Aarhus

ZIP/Postal Code

DK8200

Country

Denmark

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alex Laursen, MD, DMSci

Phone

+45-89495566

First Name & Middle Initial & Last Name & Degree

Ole Søgaard, MD

12. IPD Sharing Statement

Learn more about this trial

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

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