Observational Study for the Evaluation of the Role of HIV-1 Tat Protein and Anti-Tat Immune Response in Peripheral Blood HIV Reservoir Dynamics
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- HIV proviral DNA levels
研究概览
简要总结
A longitudinal observational study in HIV-infected subjects receiving cART addressed to explore the effect of the Tat protein and anti-Tat immunity on the formation and maintenance of HIV-1 virus reservoir.
详细描述
The study is designed as a longitudinal observational study addressed to identify the effects of Tat protein and humoral/cellular anti-Tat immune responses (induced in the natural infection or by Tat vaccination) in HIV-1 reservoir dynamics in blood of HIV infected patients receiving cART. HIV DNA data will be used for analyzing the decay dynamics.
The primary objective of the study is to determine the rate of decay of total HIV DNA in blood of anti-Tat antibody (Ab) positive versus anti-Tat Ab negative HIV patients receiving cART.
The secondary objectives of the study are to relate the HIV DNA decay data to:
- the persistence of anti-Tat humoral responses;
- biomarkers of HIV reservoir stability potentially affected by the Tat protein or anti-Tat immune responses, including: i) apoptotic/survival index of CD4+ T cells; ii) reactivation dynamics of latent HIV in resting CD4+ T cells upon exposure to Tat protein and/or activation stimuli; iii) cellular and humoral biomarkers relevant to inflammation and immune dysregulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age ≥18 years
- •Diagnosis of HIV-1 infection
- •To be under cART treatment
- •CD4+ T-cell count ≥250 cells/microliters
- •Testing for anti-Tat Ab performed during pre-screening
- •Signed informed consent
排除标准
- •Current therapy with immunomodulators or immunosuppressive drugs or chemotherapy for neoplastic disorders.
结局指标
主要结局
HIV proviral DNA levels
时间窗: Baseline and through study completion, an average of 3 years
Changes of total HIV-1 proviral DNA copies/1.000.000 CD4+ T-cells
HIV plasma viremia
时间窗: Baseline and through study completion, an average of 3 years
Changes of HIV plasma viral load (copies/mL)
CD4+ and CD8+ T-cell levels
时间窗: Baseline and through study completion, an average of 3 years
Changes of CD4+ and CD8+ T-cell counts (cells/microL)
次要结局
- Anti-Tat Ab isotypes(Baseline and through study completion, an average of 3 years)
- Induction of replication of competent latent HIV-1 from resting CD4+ T-cell(Baseline and through study completion, an average of 3 years)
- lymphocytes subset apoptosis(Baseline and through study completion, an average of 3 years)
- Inflammation/immune activation biomarkers(Baseline and through study completion, an average of 3 years)
研究者
Barbara Ensoli, MD, PhD
Director, National HIV/AIDS Research Center (CNAIDS)
Istituto Superiore di Sanità