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Completed

NCT Number: NCT05381844

Quantification of Antisense HIV RNA in Patients

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jean-Paul VIARD

Paris, 75004, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

30 ml blood sampling for virological research

Primary outcomes

  1. HIV-1 antisense transcripts in PBMCs

    Time frame: 30 months

    Quantification of total antisense transcripts with quantitative PCR and digital RT-PCR

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

Quantification of Antisense VIH-1 Transcripts and Comparison in Different Groups of Patients

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 19, 2022
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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