HIV InfectionsPhase 3HEPVACHIVNCT00451984
Hepatitis Vaccination in HIV Infection: Role of Adjuvant Interleukin-2
A Phase 3 study testing Twinrix and interleukin-2 in people with HIV Infections and Hepatitis A, run by Aalborg University Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Hepatitis A, Hepatitis B
- What is being tested?
- Twinrix and interleukin-2
- How many people
- 80 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2007to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with stable antiretroviral therapy and negative for hepatitis A or B
Who cannot join
- Prior hepatitis A or B
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Department of Infectious Diseases, Aalborg Hospital
Aalborg, DK9000
Raquel M Iguacel, MD
Henrik Nielsen, MD, DMSci
- Not yet recruiting
Department of Infectious Diseases, Skejby Hospital
Aarhus, DK8200
Alex Laursen, MD, DMSci, +45-89495566
Ole Søgaard, MD
About this study
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.
- Conditions
- HIV Infections, Hepatitis A, Hepatitis B
- Being tested
- Twinrix, interleukin-2
- Keywords
- interleukin-2, vaccination, treatment experienced
- Medical subject headings
- HIV Infections, Hepatitis A, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TwinrixBiological
interleukin-2Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response to hepatitis A and hepatitis B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2007 (estimated)
- Study startMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Henrik Nielsen, MD, DMSci, Study chair, Aalborg Hospital, DK-9000 Aalborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451984
- Sponsor's protocol ID
- VN2005/32
- Acronym
- HEPVACHIV
- Status last verified
- Oct 2007
- First submitted
- 23 Mar 2007
- Last updated
- 1 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis Vaccination in HIV Infection: Role of Adjuvant Interleukin-2
- ClinicalTrials.gov ID
- NCT00451984
- Acronym / sponsor ID
- HEPVACHIV / VN2005/32
- Conditions
- HIV Infections, Hepatitis A, Hepatitis B
- Keywords
- interleukin-2, vaccination, treatment experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Mar 2007
- First posted
- 26 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with stable antiretroviral therapy and negative for hepatitis A or B
Key exclusion criteria (1 listed)
- Prior hepatitis A or B
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Twinrix | Biological | – |
| interleukin-2 | Biological | – |
Primary outcome
Antibody response to hepatitis A and hepatitis B
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Nielsen, MD, DMSci study chair
Aalborg Hospital, DK-9000 Aalborg, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Twinrix and interleukin-2 in people with HIV Infections and Hepatitis A, run by Aalborg University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henrik Nielsen, MD, DMSci (+45-99326525, henrik.nielsen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody response to hepatitis A and hepatitis B. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2007.