Dolutegravir and Clinical Outcomes Among ART-recipients in Brazil: A Population-based Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 3
- 主要终点
- frequency of therapy discontinuation due to any event for patients starting ART
研究概览
简要总结
Access to antiretroviral therapy (ART) in low-income and middle-income countries has been scaled-up effectively over recent years. Recently, the World Health Organization (WHO) guidelines changed to recommend the use of Dolutegravir (DTG) combined with two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir and lamivudine, for first-line ART; however, there is still a need for further data on the outcomes of DTG-based regimens for people with HIV-1.
This study aims to describe the outcomes of drug-naïve and experienced patients starting a dolutegravir (DTG)-based regimen in a large cohort of HIV - infected patients in Brazil and compare to outcomes obtained from a retrospective control group of subjects who initiated non-DTG-based ART.
详细描述
CODE is a multicenter prospective observational study to describe and quantify the outcomes of patients starting DTG-based regimens. The investigators will follow ART-naïve patients starting DTG-based regimens (Group 1), patients on stable ART regimens switching to DTG (any reason) (Group 2), and ART-experienced patients switching to DTG-containing regimens due to virological failure (Group 3). In addition, for comparison purposes, the investigators will collect data on patients who started a non-DTG containing regimen (Group 4) in the period for 2014-2016 and did not switch to DTG-based regimens (Figure 1). Enrolled patients will be followed for 36 months.
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
- •• Signed informed consent.
- •HIV infection documented by plasma HIV RNA viral load, a rapid HIV test or any licensed ELISA test; and confirmed by another test using a different method, including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.
- •Age ≥ 15 years.
- •For women of child-bearing potential, willingness to use effective contraceptives.
- •Starting use of DTG-based regimen, or being initiated on a non-DTG based ART between 2014 - 2016.
排除标准
- •• Any previous use of ART (drug-naïve group only).
- •Current imprisonment, or compulsory detention (involuntary incarceration). For treatment of a psychiatric or physical illness.
结局指标
主要结局
frequency of therapy discontinuation due to any event for patients starting ART
时间窗: 36 months
The key outcomes of interest include treatment discontinuation due to any event as well as specifically due to metabolic and psychiatric events, virologic outcomes (viral suppression at 12 months, failure to ART, and genotypic results of acquired resistance), clinical outcomes (including noted side effects, retention in care, death, weight changes, hyperglycemia, diabetes, lipid changes, AIDS-defining illnesses, and recorded psychiatric and CNS effects), and special outcomes / populations (pregnancy outcomes, IRIS events, changes in HRQoL, viral hepatitis flares, and tuberculosis outcomes)
therapy discontinuation due to any event for ART-eprerienced patients starting DTG-based regimens
时间窗: 36 months
therapy discontinuation due to any event for ART-experienced patients
次要结局
- Exploratory outcomes(36 months)
- Markers of CVD risk(36 months)
- Changes in quality of life for patients switching to DTG-based regimens(6 and 12 months)
- HIV drug resistance(36 months)