- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03941210
Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients (miRNA)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Polidy PEAN, MD, PhD
- Phone Number: +85512552182
- Email: polidy@pasteur-kh.org
Study Locations
-
-
-
Phnom Penh, Cambodia
- Recruiting
- Institut Pasteur du Cambodge
-
Contact:
- Polidy PEAN, MD, PhD
- Phone Number: +85512552182
- Email: polidy@pasteur-kh.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- 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.
- 20 HIV ART naïve patients will be enrolled in Sihanouk Hospital Center of HOPE in Cambodia.
- 20 newly active tuberculosis patients will be enrolled in Sihanouk Hospital Center of HOPE in Cambodia.
- 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.
Description
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+
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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 |
MicroRNA expression profile analysis by flow cytometry
|
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 |
MicroRNA expression profile analysis by flow cytometry
|
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 |
MicroRNA expression profile analysis by flow cytometry
|
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. |
MicroRNA expression profile analysis by flow cytometry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
March 1st 2018 - March 1st 2020
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANRS 12358
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infection
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
Sociedad Andaluza de Enfermedades InfecciosasConsejeria de Salud. Junta de Andalucia. SpainCompletedHIV Infection | HIV-1 InfectionSpain
-
Beckman Coulter, Inc.CompletedHIV I Infection | HIV-2 InfectionFrance
-
Allegheny Singer Research Institute (also known...Active, not recruitingHIV Infections | HIV-1-infection | HIV I InfectionUnited States
-
Rockefeller UniversityCompletedHIV Infection | Healthy Volunteers | HIV-1 InfectionUnited States
-
Erasmus Medical CenterRecruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
Erasmus Medical CenterActive, not recruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
AIDS Healthcare FoundationUniversity of California, Los AngelesCompleted
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...CompletedHIV-1 Infection | HIV Antibodies | Neutralizing Antibody | Viral Load | Monoclonal AntibodyUnited States
Clinical Trials on Detection of molecular Biomarkers
-
University GhentUniversity Hospital, GhentCompleted
-
Istituto Clinico HumanitasIstituto Superiore di Sanità; Ospedale San Raffaele; University of Paris 5 -... and other collaboratorsUnknown
-
Assistance Publique - Hôpitaux de ParisUnknown
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingAcute Kidney Injury | Renal TransplantationFrance
-
University Medical Center GroningenRecruitingOropharynx Cancer | Unknown Primary TumorsNetherlands
-
University of MichiganCompletedKidney Diseases | Inflammation | Covid19 | SARS-CoV InfectionUnited States
-
University of FloridaCompleted
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingHereditary Transthyretin AmyloidosisItaly
-
Assistance Publique Hopitaux De MarseilleCompleted