HIV InfectionANRSHBEP03NCT02323308
Isolated Anti-HBc Serological Profile in HIV Infected Patients: Immunological, Virological Characteristics and Response to Hepatitis B Vaccination
An observational study of HIV Infection and Hepatitis B, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
The aim of study is to describe the clinical, immunological, serological, virological and therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to assess the response to vaccination in these patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infection, Hepatitis B
- What is being tested?
- blood sampling
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Jun 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with HIV infection and presenting with "isolated anti-HBc" profile. HBV vaccination is recommended fot these patients.
Who may be able to join
- HIV+ adults patients
- negative HBsAg
- negative a-HBs Ab
- positive HBc Ab
- without HBV - vaccination
- CD4 cell above 200 /mm3
- HIV viral load below 50 copies/mL
Who cannot join
- positive HBs antigenemia in the past
- transaminitis above fivefold upper normal limit
- PT<50% or Platelet <50 000/mm3
- ongoing opportunistic infection
- ongoing or recent systemic corticoid or immunomodulatory therapy, splenectomy, pregnancy, contra-indication to intramuscular injection, familial history of neurological disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Immunological, Virological, Serological Characteristics of HIV+ Patients Harboring Isolated Anti-HBc Profile and Response to Hepatitis B Vaccination
The aim of study is to describe the clinical, immunological, serological, virological and therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to assess the response to vaccination in these patients.
- Conditions
- HIV Infection, Hepatitis B
- Being tested
- blood sampling
- Medical subject headings
- HIV Infections, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
| Study group | Role | What they receive |
|---|---|---|
| vaccination | Anti-HBV vaccine injection Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of immunological, virological and serological characteristics associated to "anti-HBc isolated" profile
Measured: at Day 0, inclusion visite
Average titers of anti-HBs Ab
Measured: at 4 weeks, 28 weeks and 18 months after the first vaccination HBV
Analysis of B-cell phenotype and maturation
Measured: at baseline and at week 28
Secondary outcomes (3)
Number of patients with HBsAb titers as protective titer>10 IU/L
Measured: at 4 weeks,28 weeks and 18 month after the first dose HBV vaccin
Detection of IgG+ memory B cells specific for HBcAg or HBs Ag
Measured: at baseline and 28 weeks after the first dose HBV vaccin
- Detection of HBV preS2 and S-specific T cells
Measured: at day 0 and week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startDec 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lionel Piroth, Principal investigator, CHU DIJON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323308
- Sponsor's protocol ID
- ANRS HB EP 03 CISOVAC
- Other IDs
- 2010-A00511-38
- Acronym
- ANRSHBEP03
- Status last verified
- Dec 2014
- First submitted
- 11 Jul 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Immunological, Virological, Serological Characteristics of HIV+ Patients Harboring Isolated Anti-HBc Profile and Response to Hepatitis B Vaccination
- ClinicalTrials.gov ID
- NCT02323308
- Acronym / sponsor ID
- ANRSHBEP03 / ANRS HB EP 03 CISOVAC
- Conditions
- HIV Infection, Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Dec 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Dec 2014 (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 aim of study is to describe the clinical, immunological, serological, virological and therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to assess the response to vaccination in these patients.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccination | – | Other: blood samplingAnti-HBV vaccine injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with HIV infection and presenting with "isolated anti-HBc" profile. HBV vaccination is recommended fot these patients.
Key inclusion criteria (7 listed)
- HIV+ adults patients
- negative HBsAg
- negative a-HBs Ab
- positive HBc Ab
- without HBV - vaccination
Key exclusion criteria (5 listed)
- positive HBs antigenemia in the past
- transaminitis above fivefold upper normal limit
- PT<50% or Platelet <50 000/mm3
- ongoing opportunistic infection
- ongoing or recent systemic corticoid or immunomodulatory therapy, splenectomy, pregnancy, contra-indication to intramuscular injection, familial history of neurological disease.
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 |
|---|---|---|
| blood sampling | Other | vaccination |
Primary outcome
Evaluation of immunological, virological and serological characteristics associated to "anti-HBc isolated" profile
Time frame: at Day 0, inclusion visite
Average titers of anti-HBs Ab
Time frame: at 4 weeks, 28 weeks and 18 months after the first vaccination HBV
Analysis of B-cell phenotype and maturation
Time frame: at baseline and at week 28
3 secondary outcomes
Number of patients with HBsAb titers as protective titer>10 IU/L
Time frame: at 4 weeks,28 weeks and 18 month after the first dose HBV vaccin
Detection of IgG+ memory B cells specific for HBcAg or HBs Ag
Time frame: at baseline and 28 weeks after the first dose HBV vaccin
- Detection of HBV preS2 and S-specific T cells
Time frame: at day 0 and week 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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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.
Lionel Piroth principal investigator
CHU DIJON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and Hepatitis B, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of immunological, virological and serological characteristics associated to "anti-HBc isolated" profile (time frame: at Day 0, inclusion visite). The study lists 3 primary outcomes in all. 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 23 Dec 2014.