Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Portion of patients with a VL (viral load)< 50 Copies at week 48
研究概览
简要总结
The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with less of 100 days post HIV infection
详细描述
After providing informed consent, patients will undergo to a screening visit. If they meet the inclusion criteria and none of the exclusion will be included in this trial. Patients will take one tablet of Biktarvy at day for 48 weeks. Then the results will be compared with a cohort of 66 patients treated with 2 nucleoside analogues and one integrase chain transfer inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18-65 years
- •ART naïve
- •HIV infection of less than 100 days post-infection (documented 3 month previous negative serology or incomplete WB test with negative p31 band)
- •Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner.
排除标准
- •Known hypersensitivity to any drug included in Bictegravir/FTC/TAF regimen
- •AST >5 times UNL
- •Creatinine Clearance <30 mL/min/1.73m2
- •Any end-stage organ disease
- •Acute or chronic HCV co-infection
- •Use of PrEP with Truvada® until 4 weeks before the onset of symptoms of PHI (risk of acquired-drug resistance to FCT or TDF).
研究组 & 干预措施
Biktarvy
Patients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks
干预措施: 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide (Drug)
结局指标
主要结局
Portion of patients with a VL (viral load)< 50 Copies at week 48
时间窗: 48 weeks
Portion of patients with rapid ART (Antiretroviral therapy) initiation who reached a VL\< 50 copies at 48 week in the intention to treat population determined by PCR
次要结局
- Portion of patients with > 900 cells CD4+(weeks 24 and 48)
- Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population(week 48)
- AE rate(week 48)
- CD4, CD4/CD8 ratio(weeks 4,8,12,24,48)
- Number of required regimen changes(week 48)
- Viral Load at 4,8,12,24 y 48 weeks(weeks 4,8,12,24,48)
- Viral reservoir, inflammatory and immunological markers and fecal microbiome composition(weeks 0,48)
- Days elapsed between diagnosis and bictegravir/FTC/TAF initiation(week 48)
- AE (adverse event) leading to discontinuation rate(week 48)
- Quality of life and satisfaction: questionnaire(day 0, week 4 and 48)
研究者
Anna Cruceta
Project Manager
Fundacion Clinic per a la Recerca Biomédica