HIV Infection Clinical Trial
— miRNAOfficial title:
Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients
NCT number | NCT03941210 |
Other study ID # | ANRS 12358 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | March 1, 2020 |
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.
Status | Recruiting |
Enrollment | 134 |
Est. completion date | March 1, 2020 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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. Exclusion Criteria: - Age <18 years - Pregnancy or breastfeeding - CD4 cell count > 200 x 106 cells/l - Evidence of tuberculosis infection - Non ART naive at inclusion For HIV-/TB+ participants: Inclusion Criteria - Age = 18 years - HIV- - Confirmed tuberculosis infection. Exclusion Criteria: - Age <18 years - Pregnancy or breastfeeding - AFB negative or MTB/RIF negative for MTB, - History of TB infection - HIV+ For HIV-/TB- participants: Inclusion Criteria - Age = 18 years - HIV- - No evidence of tuberculosis infection. Exclusion Criteria: - Age <18 years - Pregnancy or breastfeeding - Evidence of tuberculosis infection - HIV+ |
Country | Name | City | State |
---|---|---|---|
Cambodia | Institut Pasteur du Cambodge | Phnom Penh |
Lead Sponsor | Collaborator |
---|---|
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) |
Cambodia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
March 1st 2018 - March 1st 2020 |
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