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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02266-35 | Registry Identifier | IDRCB |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-1-infected, untreated | Patients recently diagnosed with chronic HIV-1-infection with detectable HIV-1 RNA in plasma, sampled before treatment initiation |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other | 30 ml blood sampling for virological research |
|
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 antisense transcripts in PBMCs | Quantification of total antisense transcripts with quantitative PCR and digital RT-PCR | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between HIV-1 antisense transcripts and HIV-1 DNA in PBMCs | 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 | 30 months |
| Correlation between unspliced HIV-1 sense transcripts and HIV-1 DNA in PBMCs |
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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:
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HIV-1-infected adults, before treatment, or with undetectable viral load on treatment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean-Paul VIARD | Paris | 75004 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30700913 | 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. | |
| 30803934 |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Peripheral blood mononuclear cells obtained from a 30 ml EDTA blood sample. PBMCs will be frozen at -80°C before analyses.
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 |
| 30 months |
| Correlation between HIV-1 sense and antisense transcripts in PBMCs | 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 | 30 months |
| Comparison of untreated patients vs. patients with virological control on treatment. | Study whether the correlations are different in HIV-1-infected persons with ongoing viral replication and persons with virological control on antiretroviral treatment. | 30 months |
| Result |
| 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. |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |