HIV InfectionmiRNANCT03941210
Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients
An observational study of HIV Infection and Tuberculosis Infection, run by ANRS, Emerging Infectious Diseases at 1 site in Cambodia.
Trial summary
The role of miRNAs in HIV disease is yet to be completely defined. Host miRNAs target certain HIV genes, thus can affect HIV replication and participate in viral control. miRNAs can also block HIV production through disruption of Gag assembly on cell membranes. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Tuberculosis Infection
- What is being tested?
- Detection of molecular Biomarkers
- How many people
- 134 participants
- Where
- 1 siteCambodia
- Study dates
- 1 Mar 2018to 1 Mar 2020
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. 74 TB - HIV co-infected patients (37 TB-IRIS and 37 non TB-IRIS) whose plasma were stored during the ANRS 12095 CAMELIA clinical trial (NCT00226434) and ANRS 12153 CAPRI NK study will be included in the study. 2. 20 HIV ART naïve patients will be enrolled in Sihanouk Hospital Center of HOPE in Cambodia. 3. 20 newly active tuberculosis patients will be enrolled in Sihanouk Hospital Center of HOPE in Cambodia. 4. 20 healthy individuals will be recruited from the patients coming to Pasteur Institute in Cambodia for pre-marital test for HIV and who agree to participate in the study.
Who may be able to join
- cf the CAMELIA clinical trial (NCT00226434)
- Age ≥ 18 years
- HIV+
- CD4 cell count ≤ 200 x 106 cells/l
- No evidence of tuberculosis infection.
- Age ≥ 18 years
Show all 11Show fewer
- HIV-
- Confirmed tuberculosis infection.
- Age ≥ 18 years
- HIV-
- No evidence of tuberculosis infection.
Who cannot join
- cf the CAMELIA clinical trial (NCT00226434)
- For HIV+/TB- participants:
- Age <18 years
- Pregnancy or breastfeeding
- CD4 cell count > 200 x 106 cells/l
- Evidence of tuberculosis infection
Show all 18Show fewer
- Non ART naive at inclusion
- For HIV-/TB+ participants:
- Age <18 years
- Pregnancy or breastfeeding
- AFB negative or MTB/RIF negative for MTB,
- History of TB infection
- HIV+
- For HIV-/TB- participants:
- Age <18 years
- Pregnancy or breastfeeding
- Evidence of tuberculosis infection
- HIV+
Trial locations and contacts
1 site in 1 country.
Cambodia1 site, 1 recruiting
- Recruiting
Institut Pasteur du Cambodge
Phnom Penh
Polidy PEAN, MD, PhD, +85512552182, polidy@pasteur-kh.org
About this study
The role of miRNAs in HIV disease is yet to be completely defined. Host miRNAs target certain HIV genes, thus can affect HIV replication and participate in viral control. miRNAs can also block HIV production through disruption of Gag assembly on cell membranes. miRNA expression can characterize HIV disease phenotype, as has been shown in HIV elite controllers who have a well-defined miRNA expression profile. However, the studies of miRNA in acute infection and co-infections like tuberculosis are lacking. The investigators showed that during immune reconstitution syndrome (IRIS) in HIV/TB coinfected patients, innate immune response play a role as through NK cell degranulation, therefore testing for this could be used as a predictive marker of IRIS.
One of the limitations of miRNA detection is the technique, which is time-consuming, and needs laboratories that are specialized and equipped for molecular biology techniques. In contrast, flow cytometry has been developed in routine labs and has well-standardized techniques. For the routine detection of miRNA, flow cytometry could be the best way to perform high throughput screening for clinical applications.
Read more
Flow cytometry is a simple and effective way to evaluate miRNAs expression. In this project the investigators propose to evaluate, using flow cytometry, whether circulating miRNA pattern might be applicable as potential biomarkers in prediction and prognosis of IRIS in HIV/TB co-infected patients. The investigators propose to study the miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution. As controls, the investigators propose to analyze expression of miRNAs in healthy controls as well as TB and HIV mono-infected patients.
AIMS OF THE PROPOSAL
- Identify miRNA expression profile as potential novel predictive and prognostic biomarkers for IRIS.
- Identify the miRNA expression profile in HIV patients, in TB patients and in HIV/TB co-infected patients.
- Conditions
- HIV Infection, Tuberculosis Infection
- Being tested
- Detection of molecular Biomarkers
- Keywords
- microRNA, HIV, Tuberculosis, IRIS, Biomarkers
- Medical subject headings
- HIV Infections, Latent Tuberculosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of molecular BiomarkersOther
MicroRNA expression profile analysis by flow cytometry
| Study group | Role | What they receive |
|---|---|---|
| HIV+/TB+ | Frozen samples and data from participants recruited in the ANRS 12095 CAMELIA clinical trial and the ANRS 12153 CAPRI NK study will be used for this study arm
All plasma samples were collected before any treatment during IRIS diagnosis and at W8 post TB treatment initiation Receives: Other: Detection of molecular Biomarkers | |
| HIV+/TB- | Participants included in this study arm will be HIV+ and TB-
One time collection of 5 ml of blood will be drawn in EDTA tube for each patient before starting cART and sent to the laboratory for protocol analysis Receives: Other: Detection of molecular Biomarkers | |
| HIV-/TB+ | Participants included in this study arm will be HIV- and TB+
Collection of 5 ml of blood drawing in EDTA tube will be requested for each patient before starting TB drug treatment and after week 2 and 8 of treatment Receives: Other: Detection of molecular Biomarkers | |
| HIV-/TB- | Participants included in this study arm will be HIV- and TB-
Clinical examination to rule out overt evidence of TB and, whenever needed, routine TB testing as per national guidelines (sputum smear ± chest X-ray) in case of symptoms/clinical manifestations suggestive of TB. Receives: Other: Detection of molecular Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution
Evaluate, using flow cytometry, whether circulating miRNA (in plasma and/or exosomes) pattern might be applicable as potential biomarkers in prediction and prognosis of IRIS in HIV/TB co-infected patients.
Description of miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution.
Measured: March 1st 2018 - March 1st 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Mar 2018
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
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
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941210
- Sponsor's protocol ID
- ANRS 12358
- Acronym
- miRNA
- Status last verified
- Jan 2020
- First submitted
- 6 May 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients
- ClinicalTrials.gov ID
- NCT03941210
- Acronym / sponsor ID
- miRNA / ANRS 12358
- Conditions
- HIV Infection, Tuberculosis Infection
- Keywords
- microRNA, HIV, Tuberculosis, IRIS, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 7 May 2019 (actual)
- 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 role of miRNAs in HIV disease is yet to be completely defined. Host miRNAs target certain HIV genes, thus can affect HIV replication and participate in viral control. miRNAs can also block HIV production through disruption of Gag assembly on cell membranes. miRNA expression can characterize HIV disease phenotype, as has been shown in HIV elite controllers who have a well-defined miRNA expression profile. However, the studies of miRNA in acute infection and co-infections like tuberculosis are lacking. The investigators showed that during immune reconstitution syndrome (IRIS) in HIV/TB coinfected patients, innate immune response play a role as through NK cell degranulation, therefore testing for this could be used as a predictive marker of IRIS.
One of the limitations of miRNA detection is the technique, which is time-consuming, and needs laboratories that are specialized and equipped for molecular biology techniques. In contrast, flow cytometry has been developed in routine labs and has well-standardized techniques. For the routine detection of miRNA, flow cytometry could be the best way to perform high throughput screening for clinical applications.
Flow cytometry is a simple and effective way to evaluate miRNAs expression. In this project the investigators propose to evaluate, using flow cytometry, whether circulating miRNA pattern might be applicable as potential biomarkers in prediction and prognosis of IRIS in HIV/TB co-infected patients. The investigators propose to study the miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution. As controls, the investigators propose to analyze expression of miRNAs in healthy controls as well as TB and HIV mono-infected patients.
AIMS OF THE PROPOSAL
- Identify miRNA expression profile as potential novel predictive and prognostic biomarkers for IRIS.
- Identify the miRNA expression profile in HIV patients, in TB patients and in HIV/TB co-infected patients.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV+/TB+ | – | Other: Detection of molecular BiomarkersFrozen samples and data from participants recruited in the ANRS 12095 CAMELIA clinical trial and the ANRS 12153 CAPRI NK study will be used for this study arm All plasma samples were collected before any treatment during IRIS diagnosis and at W8 post TB treatment initiation |
| HIV+/TB- | – | Other: Detection of molecular BiomarkersParticipants included in this study arm will be HIV+ and TB- One time collection of 5 ml of blood will be drawn in EDTA tube for each patient before starting cART and sent to the laboratory for protocol analysis |
| HIV-/TB+ | – | Other: Detection of molecular BiomarkersParticipants included in this study arm will be HIV- and TB+ Collection of 5 ml of blood drawing in EDTA tube will be requested for each patient before starting TB drug treatment and after week 2 and 8 of treatment |
| HIV-/TB- | – | Other: Detection of molecular BiomarkersParticipants included in this study arm will be HIV- and TB- Clinical examination to rule out overt evidence of TB and, whenever needed, routine TB testing as per national guidelines (sputum smear ± chest X-ray) in case of symptoms/clinical manifestations suggestive of TB. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. 74 TB - HIV co-infected patients (37 TB-IRIS and 37 non TB-IRIS) whose plasma were stored during the ANRS 12095 CAMELIA clinical trial (NCT00226434) and ANRS 12153 CAPRI NK study will be included in the study. 2. 20 HIV ART naïve patients will be enrolled in Sihanouk Hospital Center of HOPE in Cambodia. 3. 20 newly active tuberculosis patients will be enrolled in Sihanouk Hospital Center of HOPE in Cambodia. 4. 20 healthy individuals will be recruited from the patients coming to Pasteur Institute in Cambodia for pre-marital test for HIV and who agree to participate in the study.
Key inclusion criteria (11 listed)
- cf the CAMELIA clinical trial (NCT00226434)
- Age ≥ 18 years
- HIV+
- CD4 cell count ≤ 200 x 106 cells/l
- No evidence of tuberculosis infection.
Key exclusion criteria (18 listed)
- cf the CAMELIA clinical trial (NCT00226434)
- Age <18 years
- Pregnancy or breastfeeding
- CD4 cell count > 200 x 106 cells/l
- Evidence of tuberculosis infection
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 |
|---|---|---|
| Detection of molecular BiomarkersMicroRNA expression profile analysis by flow cytometry | Other | HIV+/TB+, HIV+/TB-, HIV-/TB+, HIV-/TB- |
Primary outcome
miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution
Time frame: March 1st 2018 - March 1st 2020
Evaluate, using flow cytometry, whether circulating miRNA (in plasma and/or exosomes) pattern might be applicable as potential biomarkers in prediction and prognosis of IRIS in HIV/TB co-infected patients. Description of miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: No
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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.
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 Tuberculosis Infection, run by ANRS, Emerging Infectious Diseases at 1 site in Cambodia.
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 11 inclusion and 18 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 7 Jan 2020. 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 Cambodia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Polidy PEAN, MD, PhD (+85512552182, polidy@pasteur-kh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution (time frame: March 1st 2018 - March 1st 2020). 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 7 Jan 2020.