HIV InfectionsNCT00806845
Examination of B Cell Responses in Human Blood
An observational study of HIV Infections, run by Regenerative Medicine Network at 1 site in Germany.
Trial summary
The aim of this study is the assessment B-cell immune responses in HIV-infected individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Feb 2010
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV patients and controls attending specialised clinics, Germany
Who may be able to join
- HIV-infected individuals
- controls
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gewinnung Humaner antikörperproduzierender Zellen Aus Dem Blut
The aim of this study is the assessment B-cell immune responses in HIV-infected individuals.
Read the detailed description
Groups of patients with different immune competencies will be examined. The impact of HIV infection on immune response will be assessed.
- Conditions
- HIV Infections
- Keywords
- HIV, B-lymphocyte
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV infected individuals, HIV controllers | CD4+ T cell count > 350/µl, HIV load < 1000 copies/ml | |
| HIV infected individuals, early progressors | CD4+ T cell count > 350/µl, HIV load > 1000 copies/ml | |
| HIV infected individuals, late progressors | CD4+ T cell count < 200/µl | |
| HIV infected individuals, late progressors with therapy | CD4+ T cell count < 200/µl, under ART | |
| Healthy individuals | Uninfected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antigen specific B-cell responses
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenerative Medicine Network
- Sponsor type
- Research network
- Collaborators
- University of Leipzig
- Responsible party
- Principal investigator, Christian Jassoy, Regenerative Medicine Network
- Investigators
- Christian Jassoy, MD, Study director, Universität Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806845
- Sponsor's protocol ID
- RegMedNet-001
- Status last verified
- May 2015
- First submitted
- 10 Dec 2008
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bussmann BM, Reiche S, Bieniek B, Krznaric I, Ackermann F, Jassoy C. Loss of HIV-specific memory B-cells as a potential mechanism for the dysfunction of the humoral immune response against HIV. Virology. 2010 Feb 5;397(1):7-13. doi: 10.1016/j.virol.2009.11.003. Epub 2009 Dec 4.
PubMed 19962720Kunz K, Reiche S, Dwai Y, Cordes C, Krznaric I, Bussmann BM, Jassoy C. A broad spectrum of functional HIV-specific memory B cells in the blood of infected individuals with high CD4+ T-cell counts. J Acquir Immune Defic Syndr. 2011 Jul 1;57(3):e56-8. doi: 10.1097/QAI.0b013e31821dd9d1. No abstract available.
PubMed 21860350Reiche S, Nestler C, Sieg M, Schulz K, Cordes C, Krznaric I, Jassoy C. Hepatitis C virus (HCV)-specific memory B-cell responses in transiently and chronically infected HIV positive individuals. J Clin Virol. 2014 Apr;59(4):218-22. doi: 10.1016/j.jcv.2014.01.023. Epub 2014 Feb 4.
PubMed 24566009
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gewinnung Humaner antikörperproduzierender Zellen Aus Dem Blut
- ClinicalTrials.gov ID
- NCT00806845
- Acronym / sponsor ID
- RegMedNet-001
- Conditions
- HIV Infections
- Keywords
- HIV, B-lymphocyte
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Regenerative Medicine NetworkResearch network
- Collaborators
- University of Leipzig
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Dec 2008 (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 this study is the assessment B-cell immune responses in HIV-infected individuals.
Detailed description
Groups of patients with different immune competencies will be examined. The impact of HIV infection on immune response will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HIV infected individuals, HIV controllers | – | –CD4+ T cell count > 350/µl, HIV load < 1000 copies/ml |
| HIV infected individuals, early progressors | – | –CD4+ T cell count > 350/µl, HIV load > 1000 copies/ml |
| HIV infected individuals, late progressors | – | –CD4+ T cell count < 200/µl |
| HIV infected individuals, late progressors with therapy | – | –CD4+ T cell count < 200/µl, under ART |
| Healthy individuals | – | –Uninfected |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV patients and controls attending specialised clinics, Germany
Key inclusion criteria (2 listed)
- HIV-infected individuals
- controls
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antigen specific B-cell responses
Time frame: 18 months
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 13 May 2015.
- Results publication: PubMed 19962720Bussmann BM, Reiche S, Bieniek B, Krznaric I, Ackermann F, Jassoy C. Loss of HIV-specific memory B-cells as a potential mechanism for the dysfunction of the humoral immune response against HIV. Virology. 2010 Feb 5;397(1):7-13. doi: 10.1016/j.virol.2009.11.003. Epub 2009 Dec 4.
- Results publication: PubMed 21860350Kunz K, Reiche S, Dwai Y, Cordes C, Krznaric I, Bussmann BM, Jassoy C. A broad spectrum of functional HIV-specific memory B cells in the blood of infected individuals with high CD4+ T-cell counts. J Acquir Immune Defic Syndr. 2011 Jul 1;57(3):e56-8. doi: 10.1097/QAI.0b013e31821dd9d1. No abstract available.
- Results publication: PubMed 24566009Reiche S, Nestler C, Sieg M, Schulz K, Cordes C, Krznaric I, Jassoy C. Hepatitis C virus (HCV)-specific memory B-cell responses in transiently and chronically infected HIV positive individuals. J Clin Virol. 2014 Apr;59(4):218-22. doi: 10.1016/j.jcv.2014.01.023. Epub 2014 Feb 4.
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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.
Christian Jassoy, MD study director
Universität Leipzig
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 Infections, run by Regenerative Medicine Network at 1 site in Germany.
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 2 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: finished, as of the sponsor's last update on 13 May 2015. 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 Germany. 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?
Antigen specific B-cell responses (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00806845, which also lists 3 linked publications.
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 13 May 2015.