NCT00451984

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3 hiv-infections

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2007

Completed
Last Updated

November 1, 2007

Status Verified

October 1, 2007

First QC Date

March 23, 2007

Last Update Submit

October 31, 2007

Conditions

HIV InfectionsHepatitis AHepatitis B

Keywords

interleukin-2vaccinationtreatment experienced

Outcome Measures

Primary Outcomes (1)

  • Antibody response to hepatitis A and hepatitis B

Interventions

TwinrixBIOLOGICAL
interleukin-2BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Prior hepatitis A or B

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Infectious Diseases, Aalborg Hospital

Aalborg, DK9000, Denmark

RECRUITING

Department of Infectious Diseases, Skejby Hospital

Aarhus, DK8200, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

HIV InfectionsHepatitis AHepatitis B

Interventions

twinrixInterleukin-2

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanEnterovirus InfectionsPicornaviridae InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepadnaviridae InfectionsDNA Virus Infections

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Henrik Nielsen, MD, DMSci

    Aalborg Hospital, DK-9000 Aalborg, Denmark

    STUDY CHAIR

Central Study Contacts

Henrik Nielsen, MD, DMSci

CONTACT

+45-99326525henrik.nielsen@rn.dk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 26, 2007

Study Start

March 1, 2007

Last Updated

November 1, 2007

Record last verified: 2007-10

Locations

DK(2)