Quantification of Antisense HIV RNA in Patients

NCT05381844 | Completed

• 2 other identifiers: C21-162021-A02266-35
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Keywords

HIV-1

Outcome Measures

Primary Outcomes (1)

• HIV-1 antisense transcripts in PBMCs

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

  30 months

Secondary Outcomes (4)

• Correlation between HIV-1 antisense transcripts and HIV-1 DNA in PBMCs

  30 months

• Correlation between unspliced HIV-1 sense transcripts and HIV-1 DNA in PBMCs

  30 months

• Correlation between HIV-1 sense and antisense transcripts in PBMCs

  30 months

• Comparison of untreated patients vs. patients with virological control on treatment.

  30 months

Study Arms (2)

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

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

Interventions

Blood sampling OTHER

30 ml blood sampling for virological research

HIV-1-infected, undetectable viral load; HIV-1-infected, untreated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-1-infected adults, before treatment, or with undetectable viral load on treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Jean-Paul VIARD

Paris, 75004, France

Location

Related Publications (2)

• Tremeaux P, Lenfant T, Boufassa F, Essat A, Melard A, Gousset M, Delelis O, Viard JP, Bary M, Goujard C, Rouzioux C, Meyer L, Avettand-Fenoel V; ANRS-SEROCO and PRIMO cohorts. Increasing contribution of integrated forms to total HIV DNA in blood during HIV disease progression from primary infection. EBioMedicine. 2019 Mar;41:455-464. doi: 10.1016/j.ebiom.2019.02.016. Epub 2019 Feb 23.

  PMID: 30803934 BACKGROUND

• Bruner KM, Wang Z, Simonetti FR, Bender AM, Kwon KJ, Sengupta S, Fray EJ, Beg SA, Antar AAR, Jenike KM, Bertagnolli LN, Capoferri AA, Kufera JT, Timmons A, Nobles C, Gregg J, Wada N, Ho YC, Zhang H, Margolick JB, Blankson JN, Deeks SG, Bushman FD, Siliciano JD, Laird GM, Siliciano RF. A quantitative approach for measuring the reservoir of latent HIV-1 proviruses. Nature. 2019 Feb;566(7742):120-125. doi: 10.1038/s41586-019-0898-8. Epub 2019 Jan 30.

  PMID: 30700913 BACKGROUND

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.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: October 20, 2022
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

FR (1)