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Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients

Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03941210
Acronym
miRNA
Enrollment
134
Registered
2019-05-07
Start date
2018-03-01
Completion date
2020-03-01
Last updated
2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection, Tuberculosis Infection

Keywords

microRNA, HIV, Tuberculosis, IRIS, Biomarkers

Brief 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. 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 1. Identify miRNA expression profile as potential novel predictive and prognostic biomarkers for IRIS. 2. Identify the miRNA expression profile in HIV patients, in TB patients and in HIV/TB co-infected patients.

Interventions

OTHERDetection of molecular Biomarkers

MicroRNA expression profile analysis by flow cytometry

Sponsors

ANRS, Emerging Infectious Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

For HIV+/TB+ participants: Inclusion Criteria * cf the CAMELIA clinical trial (NCT00226434)

Exclusion criteria

* cf the CAMELIA clinical trial (NCT00226434) For HIV+/TB- participants: Inclusion Criteria * Age ≥ 18 years * HIV+ * CD4 cell count ≤ 200 x 106 cells/l * No evidence of tuberculosis infection.

Design outcomes

Primary

MeasureTime frameDescription
miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolutionMarch 1st 2018 - March 1st 2020Evaluate, 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.

Countries

Cambodia

Contacts

Primary ContactPolidy PEAN, MD, PhD
polidy@pasteur-kh.org+85512552182

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026