Prospective Observational Study of HIV Positive Individuals on Suppressive HAART With Malignancy Undergoing Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Proviral DNA
研究概览
简要总结
Human Immunodeficiency Virus (HIV) infection is very successfully treated with a type of therapy called Highly Active AntiRetroviral Therapy (HAART). Although HAART has made a great improvement to the health and lives of all people living with HIV, HAART cannot be stopped because it is not able to 'cure' or eliminate the HIV virus from all cells in the body - the remaining viruses are referred to as 'latent' or sleeping virus. As soon as the HAART treatment is stopped the virus comes back (wakes up). It is for this reason that stopping HAART treatment is not recommended. However, it may be that other drugs if given with HAART could have a stronger effect on the latent virus. There is some evidence from laboratory research that suggests that some of the drugs we use to treat certain types of cancer may have an effect on the latent virus. The purpose of this research study is to use new laboratory research technology to measure the amount of 'latent' virus in people who are treated with HAART who then need to use chemotherapy treatments for cancer. We will look at whether the levels of HIV virus are reduced in patients having chemotherapy by looking at the virus levels before, during and after chemotherapy treatment. We do not know very much about how HIV persists in the body despite therapy and unless new approaches are developed, removal of the HIV virus from all cells in the body will not be possible.
详细描述
STUDY DESIGN This study will be performed at one investigational site in the UK. This is a single centre, prospective observational cohort study of HIV positive individuals on suppressive HAART with malignancy undergoing chemotherapy.
ELIGIBILITY Individuals receiving HAART and diagnosed with either lymphoma or Kaposi's sarcoma receiving combination chemotherapy agents, which include the vinca alkaloids and taxanes, will be eligible for this study.
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
- •Aged ≥ 18 years and able to give written informed consent
- •Be aware of their HIV status and the diagnosis of malignancy
- •Have a plasma viral load of < 50 HIV-1 RNA copies/ml (on suppressive HAART) at enrolment
- •Be designated to receive cytotoxic chemotherapy including one or more of the following agents: R-CHOP, ABVD, Liposomal doxorubicin (Caelyx) or liposomal daunorubicin (Daunoxome) or Paclitaxel
排除标准
- •Patients not receiving HAART
- •A detectable (>50 HIV-1 RNA copies/ml) HIV plasma viral load at screening
- •Opportunistic infections
- •Unable or unwilling to give informed consent
结局指标
主要结局
Proviral DNA
时间窗: 12 weeks postcompletion of chemotherapy
Comparison of proviral DNA quantification between baseline and at 12 weeks postcompletion of chemotherapy
次要结局
- Proviral DNA(Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy)
- Immune activation levels(Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy)
- Viral RNA(Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy)
- Ultra-low viral load(Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy)
- Histone deacetylase inhibition(Baseline, prior to mid cycle of chemotherapy, prior to the final cycle of chemotherapy, 4 weeks post chemotherapy and 12 weeks post chemotherapy)