Advanced HIV: Outcomes for Rapid ART
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Viral Suppression
研究概览
简要总结
AHORA is designed as a single-arm, open label, non-comparative, real-world prospective, observational study evaluating the outcomes for viral control and CD4 recovery/immune reconstitution in predominantly Hispanic/Latinx patients of the Rio Grande Valley (RGV) with advanced HIV who are rapidly initiated on bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) at Valley AIDS Council (VAC) dba Westbrook Clinic (WBC). This research will help to fill data gaps still present for Biktarvy in a rapid start setting among an Hispanic/Latinx population, including those with advanced HIV.
详细描述
VAC is the primary provider of HIV prevention, education and testing services and the only Ryan White funded agency providing medical care and supportive services for people with HIV in the RGV. VAC provides services to over 1700 patients with HIV, 52% of patients at VAC are diagnosed with advanced HIV disease. Generally speaking, HIV clinical trials have often lacked representation and enrollment of patients of Hispanic/Latinx ethnicity, and those with advanced HIV and this study has the potential to fill in those data gaps.
For AHORA, data from ART-naive, newly diagnosed HIV-1+ adults (18 years of age and older) with late presentation (CD4<200 or diagnosed Opportunistic infection/AIDS-defining illness) initiated on Biktarvy within 7 days from diagnosis will be collected and analyzed. Patients will be enrolled through VAC's linkage to care and RAPIDO (Rapid Start) programs. Patients appropriate for Rapid ART initiation with Biktarvy will be recruited, with a goal of 50 enrollees. Patients who agree to participate will have data collected at weeks 1,4,12, 24, 36, and 48 weeks for evaluation of time to viral suppression and efficacy, as well as evaluation of CD4 cell recovery.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ART-naive adults,18 years of age and older
- •diagnosed with HIV within 7 days of study entry
- •diagnosis of Advanced HIV: clinical (diagnosed Opportunistic Infection/AIDS-defining illness) or laboratory (CD4<200) diagnosis of advanced HIV.
排除标准
- •Known severe renal impairment (CrCl <30 mL/min/1.73 m2);
- •Known or suspected severe hepatic impairment or unstable liver disease (Child Pugh Class C);
- •Use of rifamycins for treatment of OIs
- •use of concomitant medications that would be contraindicated for coadministration with Biktarvy;
- •OI diagnosis requiring initiation of OI treatment for >7 days prior to initiation of ART.
- •pregnant at time of diagnosis
研究组 & 干预措施
AHORA group
All 50 prospective subjects are enrolled into a single cohort, all subjects must meet inclusion/exclusion criteria
干预措施: Bictegravir/emtricitabine/tenofovir alafenamide (Drug)
结局指标
主要结局
Viral Suppression
时间窗: 24 weeks
To evaluate efficacy and time to HIV viral suppression of Biktarvy in Rapid Start setting for persons with Advanced HIV
次要结局
- Viral Suppression(48 weeks)
- CD4 cell recovery(48 weeks)