Efficacy and Safety of First-line Antiretroviral Therapy (ART) With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Introduced at the First Clinical Visit: a Real-life Retrospective Single Arm Single Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Virological suppression (HIV-1 RNA below 50 copies/mL plasma)
研究概览
简要总结
Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is a recommended first-line antiretroviral regimen. Croatia has a centralized care for people living with HIV (PLWH) and all persons are seen and treated in a single center, preferably in a same-day initiation model whenever suitable. This retrospective cohort study evaluated antiretroviral therapy (ART) naïve PLWH who initiated BIC/FTC/TAF, in a same-day model. The goal of the study is to assess safety and efficacy of this model by collecting information from the electronic database of the Croatian HIV Reference Centre.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •HIV seropositivity confirmed by a fourth generation test
- •the subject had not previously taken ART
- •ART was started within 24 hours of the first examination
排除标准
- •persons under 18 years of age
- •people who are pregnant, breastfeeding or planning to become pregnant
- •unacceptable interaction with a drug that the subject is already taking
结局指标
主要结局
Virological suppression (HIV-1 RNA below 50 copies/mL plasma)
时间窗: 12±3 months of ART (BIC/FTC/TAF)
Virological suppression (HIV-1 RNA below 50 copies/mL plasma) after 12±3 months of antiretroviral treatment with first-line ART (BIC/FTC/TAF) initiated at first clinical contact
次要结局
- Side effect to the drug BIC/FTC/TAF(through study completion, an average of 1 year)
- Change in CD4+/CD8+ T-lymphocytes ratio(6 and 12 months of treatment)
- HIV-1 RNA 50-200 copies/mL(6 and 12 months of treatment)
- HIV-1 RNA above 200 copies/mL(6 and 12 months of treatment)
- Virological failure(6 and 12 months of treatment)
- Number of CD4+ T-lymphocytes(6 and 12 months of treatment)
- Change in weight(6 and 12 months of treatment)
- Change in eGFR(6 and 12 months of treatment)
- Lipids concentration(6 and 12 months of treatment)
- Change in liver enzymes(6 and 12 months of treatment)