Immune Reconstitution Inflammatory SyndromeIRISNCT01557803
Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome
An observational study of Immune Reconstitution Inflammatory Syndrome and Opportunistic Infections, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Gabon.
Trial summary
The objective of this project is to determine clinical and biological predictors of Immune Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of this syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Reconstitution Inflammatory Syndrome, Opportunistic Infections
- How many people
- 107 participants
- Where
- 1 siteGabon
- Study dates
- Jan 2012to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult HIV patients starting anti retroviral therapy for the first time
Who may be able to join
- Age > 18 years
- Informed consent
- ART naive
Who cannot join
- No informed consent
- History of ART use
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Gabon1 site
Medical Research Unit - Albert Schweitzer Hospital
Lambaréné, Moyen Ogoué, BP118
About this study
Official title: Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome in Lambaréné, Gabon
The objective of this project is to determine clinical and biological predictors of Immune Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of this syndrome. The investigators will prospectively study HIV infected patients in Sub Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its different appearances. In these patients, the investigators will assess the value of clinical features and plasma biomarkers to predict IRIS, and the investigators will obtain insight into which inflammatory pathways become activated during IRIS. This project will provide novel knowledge about this clinically highly relevant healthcare problem in a resource poor setting, namely in Lambaréné, Gabon, in the Central African rainforest belt. In Gabon little research has been done in the field of HIV. The epidemiological pattern of IRIS in Gabon will be described. Promising putative plasma biomarkers will be validated for their use in daily practice.
- Keywords
- Immune reconstitution inflammatory syndrome, Biomarkers, HIV, ART, predictive factors, epidemiological pattern, Gabon
- Medical subject headings
- Immune Reconstitution Inflammatory Syndrome, Opportunistic 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 |
|---|---|---|
| Starting ART | Adult patients starting anti retroviral therapy for the first time |
What is being measured
The primary outcome is the main question the study is designed to answer.
IRIS
Development of immune reconstitution inflammatory syndrome
Measured: 12 months
Secondary outcomes (1)
Time to IRIS
Time to development of immune reconstitution inflammatory syndrome
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Reconstitution Inflammatory SyndromeStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, Albert Schweitzer Hospital
- Responsible party
- Principal investigator, S. Janssen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- MP Grobusch, MD, MSc, Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557803
- Sponsor's protocol ID
- MRU-HAS 006/2012
- Acronym
- IRIS
- Status last verified
- Jan 2015
- First submitted
- 16 Mar 2012
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome in Lambaréné, Gabon
- ClinicalTrials.gov ID
- NCT01557803
- Acronym / sponsor ID
- IRIS / MRU-HAS 006/2012
- Keywords
- Immune reconstitution inflammatory syndrome, Biomarkers, HIV, ART, predictive factors, epidemiological pattern, Gabon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- University Hospital Tuebingen, Albert Schweitzer Hospital
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Mar 2012 (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 objective of this project is to determine clinical and biological predictors of Immune Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of this syndrome. The investigators will prospectively study HIV infected patients in Sub Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its different appearances. In these patients, the investigators will assess the value of clinical features and plasma biomarkers to predict IRIS, and the investigators will obtain insight into which inflammatory pathways become activated during IRIS. This project will provide novel knowledge about this clinically highly relevant healthcare problem in a resource poor setting, namely in Lambaréné, Gabon, in the Central African rainforest belt. In Gabon little research has been done in the field of HIV. The epidemiological pattern of IRIS in Gabon will be described. Promising putative plasma biomarkers will be validated for their use in daily practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Starting ART | – | –Adult patients starting anti retroviral therapy for the first time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult HIV patients starting anti retroviral therapy for the first time
Key inclusion criteria (3 listed)
- Age > 18 years
- Informed consent
- ART naive
Key exclusion criteria (3 listed)
- No informed consent
- History of ART use
- Pregnancy
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
IRIS
Time frame: 12 months
Development of immune reconstitution inflammatory syndrome
1 secondary outcome
Time to IRIS
Time frame: 12 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 14 Jan 2015.
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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.
MP Grobusch, MD, MSc study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 Immune Reconstitution Inflammatory Syndrome and Opportunistic Infections, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Gabon.
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 3 inclusion and 3 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 14 Jan 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 Gabon. 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?
IRIS (time frame: 12 months). 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 14 Jan 2015.