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Quantification of Antisense HIV RNA in Patients

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: NCT05381844
Recruitment Status : Recruiting
First Posted : May 19, 2022
Last Update Posted : December 22, 2022
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
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Brief Summary:
The objective of this study is to quantify the expression levels of the HIV-1 unspliced sense transcript and of total HIV-1 antisense transcripts in PBMCs of HIV-1-infected persons, either still untreated or virologically controlled on treatment, and to investigate their correlations with the HIV reservoir as assessed by the quantification of total and integrated HIV-1 DNA.

Condition or disease Intervention/treatment
HIV-1-infection Other: Blood sampling

Detailed Description:

The research team will quantify the expression level of total HIV-1 antisense transcripts in PBMCs from two groups of HIV-1-infected persons: still untreated and virologically controllled on treatment.

The research team will also study (i) the correlation between the expression level of total HIV-1 antisense transcripts and the levels of total and integrated HIV-1 DNA in PBMCs, (ii) the correlation between the expression level of the unspliced HIV-1 sense transcript and the levels of total and integrated HIV-1 DNA in PBMCs, (iii) the correlation between the expression levels of total HIV-1 antisense transcripts and the level of the unspliced HIV-1 sense transcript in PBMCs, (iv) whether the correlations are different in the two groups of HIV-1-infected persons : still untreated patients vs. patients with virological control on antiretroviral treatment. Quantification of viral transcripts will rely on quantitative RT-PCRs, yielding the quantity of viral RNAs, normalized on the expression of 2 housekeeping genes, and on a digital RT-PCR, yielding the absolute number of viral RNA copies.

The quantification of total and integrated HIV-1 DNA will rely on a quantitative PCR yielding the number of HIV-1 DNA copies/million of PBMCs, according to the technique described in Tremeaux P et al, EBioMedicine 2019;41:455-64. The percentage of intact proviral DNA will be estimated according to the technique described in Bruner KM et al, Nature 2019; 566 :120-5

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantification of Antisense VIH-1 Transcripts and Comparison in Different Groups of Patients
Actual Study Start Date : October 20, 2022
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort Intervention/treatment
HIV-1-infected, untreated
Patients recently diagnosed with chronic HIV-1-infection with detectable HIV-1 RNA in plasma, sampled before treatment initiation
 Other: Blood sampling
30 ml blood sampling for virological research
HIV-1-infected, undetectable viral load
Patients with chronic HIV-1 infection on antiretroviral treatment for less than a year, with a plasma HIV-1 RNA < 50 copies/ml plasma since at least 6 months
 Other: Blood sampling
30 ml blood sampling for virological research


Outcome Measures
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Primary Outcome Measures :
  1. HIV-1 antisense transcripts in PBMCs [ Time Frame: 30 months ]
    Quantification of total antisense transcripts with quantitative PCR and digital RT-PCR


Secondary Outcome Measures :
  1. Correlation between HIV-1 antisense transcripts and HIV-1 DNA in PBMCs [ Time Frame: 30 months ]
    Study of the correlation between the expression level of total HIV-1 antisense transcripts and the level of total and integrated HIV-1 DNA in PBMCs

  2. Correlation between unspliced HIV-1 sense transcripts and HIV-1 DNA in PBMCs [ Time Frame: 30 months ]
    Study of the correlation between the expression level of unspliced HIV-1 sense transcripts and the level of total or integrated HIV-1 DNA in PBMCs

  3. Correlation between HIV-1 sense and antisense transcripts in PBMCs [ Time Frame: 30 months ]
    Study of the the correlation between the expression level of total HIV-1 antisense transcripts and the level of unspliced HIV-1 sense transcripts in PBMCs

  4. Comparison of untreated patients vs. patients with virological control on treatment. [ Time Frame: 30 months ]
    Study whether the correlations are different in HIV-1-infected persons with ongoing viral replication and persons with virological control on antiretroviral treatment.


Biospecimen Retention:   Samples Without DNA
Peripheral blood mononuclear cells obtained from a 30 ml EDTA blood sample. PBMCs will be frozen at -80°C before analyses.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-1-infected adults, before treatment, or with undetectable viral load on treatment
Criteria

Inclusion Criteria:

  • HIV-1 infection

  • ability to understand the objectives and protocols of the research and to sign the informed consent

    * group 1 : treatment-naive patients with a detectable HIV-1 viral load

  • Have not received any antiretroviral treatment

  • At the chronic stage as determined during the clinical examination and confirmed by a western blot complete HIV antigens ("env" bands (gp 120 and 160). + "gag" and "pol" bands) with the presence of p31+

    *Group 2: patients with chronic HIV-1 infection on antiretroviral therapy efficient

  • Have been on antiretroviral therapy for less than a year
  • With a plasma HIV RNA < 50 copies/mL of blood for at least 6 months

Exclusion Criteria:

  • ongoing HIV primary infection
  • coinfection with HIV-2 or HTLV-1/2
  • ongoing AIDS-defining clinical condition
  • ongoing infectious disease of any type
  • ongoing immunosuppressive treatment
  • incompetent adults, persons under the protection of a conservator, tutor or guardian
  • participation in a trial testing a medication in the 3 months preceding blood sampling
  • pregnant or lactating woman
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05381844


Contacts
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Contact: Jean-Paul VIARD, Pr 01 42 34 88 41 ext 0033 jean-paul.viard@aphp.fr
Contact: Claudine PIQUE, Dr 01 40 51 64 86 ext 0033 claudine.pique@inserm.fr

Locations
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France
Jean-Paul VIARD Recruiting
Paris, France, 75004
Contact: Jean-Paul VIARD    0142348841    jean-paul.viard@aphp.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT05381844    
Other Study ID Numbers: C21-16
2021-A02266-35 ( Registry Identifier: IDRCB )
First Posted: May 19, 2022    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
HIV-1