Hepatitis Vaccination in HIV Infection: Role of Adjuvant... | NCT00451984

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

NCT00451984

Sponsor

Aalborg University Hospital

Status

Unknown status

Last Update Posted

Nov 1, 2007Estimated

Enrollment

80Estimated

Phase

Phase 3

Conditions

HIV Infections
Hepatitis A
Hepatitis B

Interventions

Twinrix
interleukin-2

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 23, 2007

First Submission Date that Met QC Criteria

Mar 23, 2007

First Posted Date

Mar 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2007

Last Update Posted Date

Nov 1, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Measure	Description	Time Frame
Antibody response to hepatitis A and hepatitis B

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Prior hepatitis A or B

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Henrik Nielsen, MD, DMSci	Contact	+45-99326525		henrik.nielsen@rn.dk

Overall Officials

Name	Affiliation	Role
Henrik Nielsen, MD, DMSci	Aalborg Hospital, DK-9000 Aalborg, Denmark	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Infectious Diseases, Aalborg Hospital	Recruiting	Aalborg		DK9000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D006506	Hepatitis A
D006509	Hepatitis B

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C433226	twinrix
D007376	Interleukin-2

Ancestor Terms

ID	Term
D007378	Interleukins
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Twinrix	Biological
interleukin-2	Biological