Quantification of Antisense VIH-1 Transcripts and Comparison in Different Groups of Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- HIV-1 antisense transcripts in PBMCs
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
HIV-1 antisense transcripts in PBMCs
时间窗: 30 months
Quantification of total antisense transcripts with quantitative PCR and digital RT-PCR
次要结局
- 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)