A Test and Treat Strategy in Barcelona: A Prospective Study in New HIV Diagnosis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) at week 4
研究概览
简要总结
This is an open-label, single arm, single-centre prospective study to evaluate the feasibility, efficacy and safety of a once daily fixed dose combination regimen, Biktarvy, as a rapid treatment strategy in newly HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit Patients with confirmed HIV-1 diagnosis who wish to start ARV treatment immediately will receive bictegravir 50 mg + emtricitabine 200 mg + tenofovir alafenamide 25 mg within the first week since the HIV-1 confirmation during 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Having confirmed HIV-1 positive test.
- •Patients not previously treated with antiretroviral treatment (post-exposure prophylaxis will be allowed if not done in the previous 6 months).
- •Clinically stable patients, in the opinion of the investigator, at the time of inclusion.
- •Women of child-bearing potential* must have a negative pregnancy test in urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: hormonal contraceptive methods intrauterine device, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
- •Written informed consent.
排除标准
- •Pregnant or breastfeeding women at the time of the study inclusion or anticipating pregnancy during the follow-up period.
- •Suspicion of an active opportunistic infection that defers initiating antiretroviral treatment > 7 days since HIV confirmation.
- •Known hypersensitivity or intolerance of any of the components of Biktarvy®.
- •Patients on treatment with any prohibited medication (see section 5.2: Concomitant, nonpermitted and permitted medication).
- •Any condition which, in the opinion of the principal investigator, may interfere with adequate understanding, cooperation or compliance with the study.
研究组 & 干预措施
Biktarvy
This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide.
干预措施: Biktarvy (Drug)
结局指标
主要结局
Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) at week 4
时间窗: week 4
Patients will be considered non-eligible if they meet one or more of the following creiteria at week 4: * Presence of HLA-B\* 5701 or lack of HLA test * Presence of HIV genotypic resistance mutations to at least one class of ARV drug that decrease efficacy of antiretroviral treatment * CD4 count \< 200 cells/mm3 * Viral load \> 100.000 copies/mL * Comorbidities such as: Osteopenia measured by DXA (T score less than 1), medical history of cardiovascular risk measured by Framingham risk score \> 10% at 10 years, Kidney function (eGFR \<50mL/min), * Concomitant medication that can cause potential interactions with ARV (evaluating the risk of drug-drug interactions for drugs no totally safe (green colour) using the Liverpool website for DDI) * Hepatitis B (HBV) coinfection or lack of serology
次要结局
- Proportion of patients who start Biktarvy within the first week since HIV confirmation at the first visit at the HIV unit.(week 4)
- Days since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated.(week 4)
- Days since first HIV test was performed until Biktarvy is initiated.(week 4)
- Proportion of patients with plasma viral load (VIH-1 RNA) < 50 copies/mL at 4, 12, 24 and 48 weeks.(week 4, week 12, week 24 and week 48)
- Changes from week 0 in CD4 and CD8 count and CD4/CD8 ratio at 24 and 48 weeks.(week 24 and week 48)
- Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks.(week 24 and week 48)
- Proportion of patients with treatment-related adverse events during the study period.(week 48)
- Changes from baseline in systemic inflammatory and coagulation response evaluated by measurement of soluble markers including, but not limited to IL-6, ultrasensitive PCR, Dimer-D at 48 weeks.(week 48)
- Changes from baseline in senescence response evaluated by measurement of soluble markers of senescence including, but not limited to, bcl-2 apoptosis marker at 24 and 48 weeks.(week 24 and week 48)
- Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks.(week 48)
- Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period.(week 48)
- Proportion of patients who discontinue study treatment due to adverse events at 48 weeks.(week 48)
- Patient perception of rapid start of Biktarvy therapy using a specific questionnaire (CESTA) at 48 weeks.(week 48)
研究者
Judit Pich Martínez
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica