Observational Assessment of the Nation-wide Roll-out of Dolutegravir in Lesotho
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,433
- 试验地点
- 2
- 主要终点
- Quality of life screening score (change from baseline)
研究概览
简要总结
DO-REAL is an observational cohort study assessing the large-scale roll-out of the antiretroviral drug dolutegravir (DTG) in Lesotho.
DTG has been shown to have low side-effects and superior treatment outcomes for people living with HIV-1 when compared to other antiretroviral drugs currently in use in low-income countries. The use of DTG in first-line antiretroviral therapy (ART) regimens was recommended by the World Health Organisation in 2018 and adopted by the Ministry of Health in Lesotho in 2019. While DTG-based ART regimens have led to promising health outcomes in high-income and clinical trial settings, certain concerns remain regarding the risk of ART-experienced patients transitioning to a DTG-based ART regimen being placed on a functional monotherapy (increasing the otherwise low risk of viral resistance to DTG) as well as side-effects including psychological symptoms and weight gain.
Thus, the DO-REAL study intends to address these concerns and provide data on health outcomes of HIV patients on DTG in a "real-life" high-prevalence setting.
详细描述
SUMMARY: DO-REAL is an observational cohort study assessing the large-scale roll-out of the antiretroviral drug dolutegravir (DTG) in Lesotho.
BACKGROUND: DTG is a second-generation integrase strand transfer inhibitor with low side-effects and superior treatment outcomes for people living with HIV-1 when compared to other antiretroviral drugs currently in use in low-income countries. Though some cases have been described, HIV-1 resistance to DTG is rare in clinical settings when DTG is used as part of a combination therapy. The use of DTG in first-line antiretroviral therapy (ART) regimens was recommended by the World Health Organisation in 2018 and was adopted by the Ministry of Health in Lesotho in 2019. DTG now forms part of the recommended first-line therapy for many ART-naïve patients in Lesotho. In addition, many patients on a non-DTG-based first-line ART regimen will be transitioned to a DTG-based regimen.
OBJECTIVES: Despite the positive health outcomes observed in patients receiving DTG-based ART in high-income countries and in clinical trial settings, there is little data on virologic outcomes of patients on DTG during large-scale implementation in low- and lower middle-income countries. Concerns remain regarding the risk that some patients transitioning to a DTG-based regimen will be placed on a functional monotherapy. Furthermore, there are concerns as to psychological side-effects and observed weight gain. This observational study aims to assess the virologic outcomes (viral suppression rates as well as potential drug resistance) as well as side-effects of people living with HIV-1 and transitioning to a DTG-based ART regimen in Lesotho.
DO-REAL has two major objectives:
- To assess virologic outcomes after the programmatic shift to DTG-based regimens.
- To assess psychological and somatic wellbeing in patients before and after the programmatic shift to DTG-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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1-positive
- •Initiating or eligible to initiate (offered to initiate) a DTG-based ART regimen
- •Informed written consent (and assent, if applicable) provided
排除标准
- 未提供
研究组 & 干预措施
HIV-1-positive individuals
HIV-1-positive individuals eligible to receive a DTG-based ART regimen at enrolment.
干预措施: Dolutegravir (Drug)
结局指标
主要结局
Quality of life screening score (change from baseline)
时间窗: Change between time of initiation of a DTG-containing ART regimen and 4 months thereafter
12-Item Short Form Health Survey (SF-12; 12-item index in which questions are scored and weighted into 2 subscales, physical health and mental health; scores can range from 0-100 with higher scores indicating higher physical or mental health)
Virologic outcomes after programmatic transition to DTG-containing regimens
时间窗: 4 months after initiation of a DTG-containing regimen
Viral load
Depression screening score (change from baseline)
时间窗: Change between time of initiation of a DTG-containing ART regimen and 4 months thereafter
Patient Health Questionnaire-9 (PHQ-9; 9-item index with each item scored 0-3, providing a 0-27 severity score with a higher score indicating higher severity)
HIV symptom screening score (change from baseline)
时间窗: Change between time of initiation of a DTG-containing ART regimen and 4 months thereafter
Modified HIV Symptom Index (21-item index with each item scored 0-4, providing a 0-84 severity score with a higher score indicating higher severity)
次要结局
- Long-term virologic outcomes after programmatic transition to DTG-containing regimens(12 and 24 months after initiation of a DTG-containing regimen)
- Virologic status at programmatic transition to DTG-containing regimens(On day of initiation of a DTG-containing regimen)
- Viral drug resistance at programmatic transition to DTG-containing regimens(On day of initiation of a DTG-containing ART regimen)
- Reasons for discontinuation of a DTG-containing regimen(Up to 24 months after enrolment)
- Viral drug resistance after programmatic transition to DTG-containing regimens(4, 12 and 24 months after initiation of a DTG-containing regimen)
- Weight (change from baseline)(On day of initiation of a DTG-containing ART regimen and 4, 12 and 24 months thereafter)