Targeted Clinical Strategies and Low Abundance HIV Viraemia in Boosted-PI Therapy: an Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in primary protease inhibitor mutations on the HIV genome as defined by IAS-USA drug resistance mutations list.
研究概览
简要总结
The purpose of the study is to look at possible reasons why some HIV positive people who take their drugs properly and have no resistance to these drugs, still have low amounts of virus detectable in their blood. This is known as Low Level Viraemia (LLV). When low levels of HIV virus are present, some can mutate and make the drugs less effective (i.e. some variants of the virus become more resistant). Currently, however, these resistance mutations may be difficult to detect using standard tests for resistance because the amount of virus in the blood is very low and the standard tests aren't sensitive enough to pick up the mutations. The investigators will use more sensitive mutation detection methods, known as Next Generation Sequencing (NGS), to look at whether see if there are any low levels of drug resistant HIV virus developing in the blood when LLV occurs. The investigators will look at the different treatment strategies that are used in routine standard practice when LLV is detected and evaluate which is most effective in preventing development of resistance. The investigators hope this research will help to inform guidelines on the best way to treat HIV in the future.
详细描述
Phase of Study: Non-Drug Study
Objectives:
- Primary To investigate the causes of low level viraemia (LLV) in HIV-infected individuals with no PI resistance associated mutations (RAMs) on conventional genotyping who have a detectable plasma HIV viral load (pVL) and report >95% adherence* to their ARV regimens containing a boosted protease inhibitor.
*in case the questionnaire cannot be performed, clinical documentation of adherence will be used for interpretation of adherence level. 2. Secondary To observe the evolution in virologic and immunologic responses following routine clinical intervention in HIV-infected individuals with no primary protease inhibitor mutations (IAS, USA) on conventional genotyping who have a detectable plasma HIV viral load (pVL) and report >95% adherence* to antiretroviral regimens containing a boosted protease inhibitor.
- in case the questionnaire cannot be performed, clinical documentation of adherence will be used for interpretation of adherence level.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •A subject will be eligible for inclusion in the study if ALL of the following criteria apply:
- •Chronic HIV-1 infection (adult male, female or transgender)
- •Age >18 years
- •Current HIV clinic attendee at the Chelsea and Westminster Hospital, St Mary's Hospital, and Guy's and St Thomas' Hospital [defined as at least 1 attended clinic visit since January 2010]
- •Receiving a boosted protease inhibitor-containing antiretroviral regimen (bPI ARV)
- •HIV plasma viral load (pVL) of 41-2000 copies/ml (c/ml) on two consecutive tests after being <40 c/ml on at least two occasions on a bPI-containing regimen OR HIV pVL of 41-2000 c/ml on two consecutive tests having never achieved <40 c/ml on a bPI containing regimen after more than six months of treatment.
排除标准
- •A subject will NOT be eligible for inclusion in this clinical trial if the following criteria apply:
- •Demonstrable detectable HIV VL after stopping ARV
- •8-item Morisky score of 2 or more or documented poor adherence to combination ARV. (<95% adherence*)
- •in case the questionnaire cannot be performed, clinical documentation of adherence will be used for interpretation of adherence level
结局指标
主要结局
Change in primary protease inhibitor mutations on the HIV genome as defined by IAS-USA drug resistance mutations list.
时间窗: Change between baseline and 12 months after first detectble viral load
次要结局
- Proportion of patients achieving an undetectable HIV VL following an intervention following LLV on ARV regimens containing a bPI(12 months after first detectable VL on bPI)
- Change in cell count following an intervention during periods of LLV on ARV regimens containing a bPI(Change in CD4 cell count from baseline to 1 year)