Prospective Pilot Study of the Efficacy, Safety and Tolerability of Bictegravir-Based HIV ART Same-Day Treatment Evaluations (B-HASTE)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Viral Suppression
研究概览
简要总结
This study plans to learn about whether starting HIV treatment very soon after diagnosis is more beneficial than waiting until entering routine clinical care after diagnosis.
详细描述
Randomized two arm, multi-site (three sites), open label pilot study conducted with laboratory evaluation and visits at entry, 4 weeks, 12 weeks, 24 weeks, 48 weeks and 96 weeks with laboratory evaluations and assessment if participants remain engaged in care.
Participants will be randomly assigned with equal probability to one of two arms:
Arm A: Same day antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) + new diagnosis package with laboratory evaluations and social work referral.
Arm B: Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 15 years and older in Colorado and 19 years and older in Nebraska. A waiver of parental consent is planned for individuals 15-17 in accordance with Colorado law which allows minors to consent for treatment for sexually transmitted infections, including HIV.
- •Reactive HIV-1 on an approved fourth generation HIV-1 antibody/antigen test within 72 hours
- •Any primary language with access to an interpreter by phone is included.
排除标准
- •Pregnancy or intention to become pregnant in the next two years after enrollment
- •Symptomatic acute HIV (with fever, rash, influenza-like symptoms)
- •Creatinine clearance <30 mL/min by Cockcroft-Gault equation. (Therapy initiated will be terminated promptly in individuals who are found to have creatinine clearance <30 mL/min)
- •Prior history of known HIV diagnosis
- •Negative confirmatory HIV differentiation assays (therapy initiated will be terminated in individuals with negative tests and excluded from the primary analysis)
- •Allergy to bictegravir, emtricitabine or tenofovir alafenamide
- •Signs or symptoms of opportunistic infection with cryptococcal meningitis, tuberculosis or other infection that requires delay of initiation of antiretroviral therapy (up to the discretion of the site PI)
- •Vulnerable populations including prisoners and individuals without decision making capacity
- •Concommitant use of medications that are contraindicated with bictegravir, emtricitabine and tenofovir alafenamide including adefovir, carbamazepine, cladribine, dofetilide, fosphenytoin-phenytoin, oxcarbazepine, phenobarbital, primidone, rifampin, rifabutin, rifapentine, St. John's Wort, tipranavir
研究组 & 干预措施
Arm A: Rapid Start Group
Same day antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) + new diagnosis package with laboratory evaluations and social work referral.
干预措施: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) (Drug)
Arm B: Standard Group
Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.
干预措施: Standard initiation of antiretroviral therapy (ART) (Drug)
结局指标
主要结局
Viral Suppression
时间窗: 48 weeks
Proportion of participants with viral suppression to \<50 copies/mL at 48 weeks by FDA snapshot in the rapid-start ART arm compared to the standard of care arm.
次要结局
未报告次要终点