HIV Study on MEasuring the Reservoir on Cellular Level to CUre Infection (HIV-Mercuri)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04305665|
Recruitment Status : Not yet recruiting
First Posted : March 12, 2020
Last Update Posted : October 14, 2020
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
The aim of this study is to gain new insights into HIV latency and reversal through extensive blood and tissues sampling (lymph node and colon biopsies) from 25 individuals under ART.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||HIV Study on MEasuring the Reservoir on Cellular Level to CUre Infection|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2025|
|HIV-1 positive persons|
Primary Outcome Measures :
- Quantification of HIV DNA and RNA [ Time Frame: 5 years ]Digital PCR
- Integration site analysis [ Time Frame: 5 years ]HIV/host DNA junctions will be amplified using the Integration Site Loop Amplification (ISLA) assay, and resulting chimeric amplicons will be sequenced by Sanger.
- Full-length HIV genome analysis [ Time Frame: 5 years ]Full-Length Individual Proviral Sequencing (FLIPS) assay: nested PCR with Illumina MiSeq.
- Epigenetic analysis [ Time Frame: 5 years ]Methylation (bisulfite conversion) and chromatin accessibility (Assay for Transposase-Accessible Chromatin using sequencing)
- Transcriptome analysis [ Time Frame: 5 years ]
- Bulk RNA sequencing on extracted RNA (Illumina Hiseq 2500 with 10-100 ng input of ribodepleted RNA)
- Single cell RNA sequencing (10x genomics technology )
- High dimensional phenotyping [ Time Frame: 5 years ]CyTOF (mass cytometry, Fluidigm) combined with bioinformatics approach to extensively characterize the phenotype of latently infected cells
- Immunohistochemistry, RNA- and DNA In Situ Hybridization [ Time Frame: 5 years ]Immunochemistry will be used to study the expression of activation and exhaustion markers on tissues samples , while viral expression will be assessed through DNAScope and RNAScope technologies
- Extracellular vesicles analysis [ Time Frame: 5 years ]Extracellular vesicles (EV) will be isolated through size-exclusion chromatography (SEC) and Optiprep density gradient (ODG). The isolated EVs will be visualized by microscopy, western blot and PCR. Proteomics and RNA sequencing will be performed to assess the EV content.
- Immunometabolic profile analysis [ Time Frame: 5 years ]Mass spectrometry metabolomics will be used to study the immunometabolic profile of latently infected cells
- p24 quantification [ Time Frame: 5 years ]p24 SIMOA assay: ultra-sensitive digital immunoassay providing 1000 times improvement in detection limits compared with a traditional ELISA. This assay will be used to assess the capacity of various latency reversing agents and immunomodulators at reactivating HIV from latency.
- Detection of translation-competent reservoirs [ Time Frame: 5 years ]HIV-Flow assay: flow cytometry based assay using a combination of 2 antibodies targeting the p24 protein and allowing the detection of cells containing translation-competent viruses. p24+ cells detected by this assay can be sorted for downstream applications and further characterization of translation-competent reservoirs.
No Contacts or Locations Provided