HivNCT05783388
Measuring the HIV-1 Reservoir During Cure Interventions Studies (MERCI)
An observational study of Hiv, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The aim of this study is the gain new insights into HIV latency before and after cure intervention studies through extensive blood and tissue sampling (lymph node and colon biopsies) from 30 individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hiv
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2023to 1 Feb 2030
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-1 positive persons who are included in a cure intervention study
Who may be able to join
- Meets the inclusion criteria of the cure intervention study
Who cannot join
- Current history of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification), consisting of chronic HIV-1 infection.
- Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (=HBV antigen or viral load negative and positive HBV surface antibody)).
- Evidence of active HCV infection (HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry).
- Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease.
- Current history of cancer.
- History of HIV-related thrombocytopenia.
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- Pregnancy or breastfeeding.
- Any condition, including preexisting psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant.
- Abnormal results of standard of care laboratory tests:
- Confirmed haemoglobin <11g/dl for women and <12 g/dl for men
- Confirmed platelet count <100 000/µl *
- Confirmed neutrophil count <1000/μl
- Confirmed AST and/or ALT >10xULN
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry.
- The following treatment will be prohibited three months before screening and during the study:
- immunosuppressive drugs (inclusive corticosteroids) except for drugs used for topical use.
- Immunomodulatory drugs including but not limited to Granulocyte-colony stimulating factors, Granulocyte-monocyte colony-stimulating factor, interleukin 2, 7 \& 15.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring the HIV-1 Reservoir During Cure Interventions Studies
The aim of this study is the gain new insights into HIV latency before and after cure intervention studies through extensive blood and tissue sampling (lymph node and colon biopsies) from 30 individuals.
- Conditions
- Hiv
- Keywords
- HIV, Latency
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 positive persons | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of total and intact HIV DNA and HIV RNA
Rainbow assay: multiplex digital PCR approach that combines five different HIV-1 regions to quantify total HIV-1 DNA and intact HIV-1 DNA simultaneously (Qiacuity dPCR platform, Qiagen).
mutliplex digital PCR approach to quantify HIV RNA
Measured: 5 years
Integration site analysis
HIV/host DNA junctions will be amplified using the Integration Site Loop Amplification (ISLA) assay, and resulting chimeric amplicons will be sequenced by Sanger.
Measured: 5 years
Full-length HIV genome analysis
Full-Length Individual Proviral Sequencing (FLIPS) assay: nested PCR with Illumina MiSeq.
Measured: 5 years
Epigenetic analysis
Methylation (bisulfite conversion) and chromatin accessibility (Assay for Transposase-Accessible Chromatin using sequencing)
Measured: 5 years
Matched integration site and proviral sequencing
MIP-seq: captures full-length viral genome sequences in conjunction with its associated viral integration site
Measured: 5 years
Proviral UMI-mediated Long-read Sequencing
HIV-PULSE: characterize the composition of the viral reservoir using long-read sequencing. Involves pre-amplifying individual proviral genomes using PCR and tagging them with dual UMIs, followed by long-range PCR amplification and long-read sequencing on the Oxford Nanopore MinION platform
Measured: 5 years
Transcriptome analysis
- Bulk RNA sequencing on extracted RNA (Illumina Hiseq 2500 with 10-100 ng input of ribodepleted RNA)
- Single cell RNA sequencing (10x genomics technology )
Measured: 5 years
High dimensional phenotyping
CyTOF (mass cytometry, Fluidigm) combined with bioinformatics approach to extensively characterize the phenotype of latently infected cells
Measured: 5 years
Immunohistochemistry, RNA- and DNA In Situ Hybridization
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
Measured: 5 years
Immunometabolic profile analysis
Mass spectrometry metabolomics will be used to study the immunometabolic profile of latently infected cells
Measured: 5 years
Detection of translation-competent reservoirs
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.
The Simultaneous TCR Integration site and Provirus sequencing (STIP-seq) assay will be performed to sequence the proviral genome and matched integration sites of the translation-competent viruses, as well as phenotypic characterization and TCR sequencing of the host cell. characterization of translation-competent reservoirs.
Measured: 5 years
Immunological analysis-FACS
Immunophenotyping by flow cytometric assays will be performed of different cells to assess the phenotype of innate immune cells, using FACS analysis.
Measured: 5 years
Immunological analysis-ELISA
Immunophenotyping by flow cytometric assays will be performed of different cells to assess the phenotype of innate immune cells, using ELISA.
Measured: 5 years
Microbiome monitoring
Gut microbiome will be analyzed in stool and colon biopsies using next-generation sequencing (NGS) of rRNA gene amplicons to identify bacteria at genus/species level
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Jun 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2030 (estimated)
Why it stopped: The commercial partner decided not to proceed with this protocol at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linos Vandekerckhove, MD PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783388
- Sponsor's protocol ID
- ONZ-2022-0054 - MERCI
- Status last verified
- Sep 2024
- First submitted
- 13 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the HIV-1 Reservoir During Cure Interventions Studies
- ClinicalTrials.gov ID
- NCT05783388
- Acronym / sponsor ID
- ONZ-2022-0054 - MERCI
- Conditions
- Hiv
- Keywords
- HIV, Latency
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The commercial partner decided not to proceed with this protocol at this time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 24 Mar 2023 (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 aim of this study is the gain new insights into HIV latency before and after cure intervention studies through extensive blood and tissue sampling (lymph node and colon biopsies) from 30 individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-1 positive persons | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-1 positive persons who are included in a cure intervention study
Key inclusion criteria (1 listed)
- Meets the inclusion criteria of the cure intervention study
Key exclusion criteria (18 listed)
- Current history of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification), consisting of chronic HIV-1 infection.
- Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (=HBV antigen or viral load negative and positive HBV surface antibody)).
- Evidence of active HCV infection (HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry).
- Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease.
- Current history of cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantification of total and intact HIV DNA and HIV RNA
Time frame: 5 years
Rainbow assay: multiplex digital PCR approach that combines five different HIV-1 regions to quantify total HIV-1 DNA and intact HIV-1 DNA simultaneously (Qiacuity dPCR platform, Qiagen). mutliplex digital PCR approach to quantify HIV RNA
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)
Matched integration site and proviral sequencing
Time frame: 5 years
MIP-seq: captures full-length viral genome sequences in conjunction with its associated viral integration site
Proviral UMI-mediated Long-read Sequencing
Time frame: 5 years
HIV-PULSE: characterize the composition of the viral reservoir using long-read sequencing. Involves pre-amplifying individual proviral genomes using PCR and tagging them with dual UMIs, followed by long-range PCR amplification and long-read sequencing on the Oxford Nanopore MinION platform
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
Immunometabolic profile analysis
Time frame: 5 years
Mass spectrometry metabolomics will be used to study the immunometabolic profile of latently infected cells
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. The Simultaneous TCR Integration site and Provirus sequencing (STIP-seq) assay will be performed to sequence the proviral genome and matched integration sites of the translation-competent viruses, as well as phenotypic characterization and TCR sequencing of the host cell. characterization of translation-competent reservoirs.
Immunological analysis-FACS
Time frame: 5 years
Immunophenotyping by flow cytometric assays will be performed of different cells to assess the phenotype of innate immune cells, using FACS analysis.
Immunological analysis-ELISA
Time frame: 5 years
Immunophenotyping by flow cytometric assays will be performed of different cells to assess the phenotype of innate immune cells, using ELISA.
Microbiome monitoring
Time frame: 5 years
Gut microbiome will be analyzed in stool and colon biopsies using next-generation sequencing (NGS) of rRNA gene amplicons to identify bacteria at genus/species level
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Linos Vandekerckhove, MD PhD principal investigator
University Hospital, Ghent
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, run by University Hospital, Ghent at 1 site in Belgium.
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 1 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: withdrawn, as of the sponsor's last update on 19 Sep 2024. 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 Belgium. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of total and intact HIV DNA and HIV RNA (time frame: 5 years). The study lists 14 primary outcomes in all. 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 19 Sep 2024.