A Prospective Longitudinal Cohort Study to Determine the Incidence of HIV-associated Non-AIDS Conditions in Newly Diagnosed HIV-infected Individuals Initiating Integrase Inhibitor-based and Other Anti-retroviral Regimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- Prevalences of HIV-associated Non-AIDS Conditions (HANA)
研究概览
简要总结
With the availability of effective anti-retroviral therapy, HIV-infected individuals are expected not to die of AIDS and have longer life expectancy. But at the same time, HIV-associated non-AIDS (HANA) conditions are becoming more important in their clinical management. It is currently uncertain whether patients started on different anti-retroviral regimens will have different incidence of HANA conditions.
This study aims to evaluate the incidence of various HANA conditions in a cohort of newly diagnosed HIV-infected individuals in Hong Kong initiating anti-retroviral treatment. The incidence of various HANA conditions will be evaluated for those receiving INSTI versus other non-INSTI-based regimens.
The HANA conditions evaluated will include 1. Hypertension 2. Diabetes and insulin resistance 3. Dyslipidemia 4. Lipodystrophy 5. Metabolic syndrome 6. Osteopenia and osteoporosis 7. Vitamin D deficiency 8. Renal impairment and kidney tubular dysfunction and 9. Liver fibrosis. Patients will be assessed prior to initiation of anti-retroviral therapy, and 48 weeks and 96 weeks after initiation of treatment. The incidence of development of each HANA condition will be determined and compared between those initiated different anti-retroviral regimens.
详细描述
This is a prospective, longitudinal, cohort study. 150 newly diagnosed HIV-infected individuals attending HIV clinics in Hong Kong will be recruited. Clinical assessment, and laboratory and imaging studies will be performed at baseline prior to initiation of anti-retroviral regimen, then annually thereafter for 5 years. Choice of anti-retroviral regimen will be decided by the in-charge HIV physician. Incidence of development of various HANA will be determined in those initiated INSTI-based regimens and other anti-retroviral regimens. An electronic platform will be used to formulate risk prediction for various clinical outcomes, and serve as a clinical decision support tool.
Statistical analysis;
- The incidence rate of each HANA defined as above will be calculated as:
- The incidence rate of each HANA will be determined for subjects started INSTI-based regimens and other non-INSTI-anti-retroviral regimens.
- Variables, including demographic, clinical, treatment-related, and laboratory parameters, will be evaluated for association with development of various HANA, in univariate and multivariate analyses. Analyses will be performed for the whole cohort, and subgroup analyses will be performed in those initiated INSTI-based regimens and other non-INSTI-based regimens.
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
- •Confirmed HIV infection by HIV antibody or RNA test
- •Age ≥18 years old
- •Anti-retroviral treatment naïve
- •Agree to initiate anti-retroviral therapy (ART) as determined by in-charge HIV physician
排除标准
- •Unable to give informed consent
结局指标
主要结局
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
时间窗: Baseline
Participants who were assessed at baseline and at least one of follow-up visits were included in the data analysis for prevalence of HIV-associated non-AIDS conditions (HANA) Prevalences of the following HIV-associated non-AIDS conditions (HANA) were assessed at baseline. * hypertension * diabetes mellitus * insulin resistance * dyslipidemia * metabolic syndrome * osteoporosis * osteopenia * vitamin D deficiency * renal disease * kidney tubular dysfunction * intermediate or advanced fibrosis (FIB-4 \>1.3) * advanced fibrosis (FIB-4 \>2.67)
Incidence Rates of HANA Conditions for At-risk Groups
时间窗: Enrollment to 2 years
Participants who were assessed at baseline and at least one of follow-up visits were included in the data analysis for incidence rates of HANA Incidence rates of following HANA conditions were reported among at-risk INSTI and non-INSTI-based antiretroviral therapy at 2 years. * hypertension * diabetes mellitus * insulin resistance * dyslipidemia * metabolic syndrome * osteopenia * osteoporosis * vitamin D deficiency * renal disease * kidney tubular dysfunction * intermediate or advanced fibrosis (FIB-4 \> 1.3) * advanced fibrosis (FIB-4 \>2.67)
次要结局
未报告次要终点
研究者
Grace Lui
Clinical Assistant Professor
Chinese University of Hong Kong