Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai Patients in a Prospective Randomized Controlled Trial: a Proof-of-concept Study
试验速览
- 阶段
- 1 期
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- HIV RNA
研究概览
简要总结
Genetic polymorphisms of cytochrome P450 2B6 (CYP2B6) are associated with lower rate of EFV metabolism and lead to high exposure, as well as a higher risk of neuropsychiatric adverse event especially homozygous variant CYP2B6 *6/*6. This trial was designed to compare the proportion of patients who had undetectable HIV RNA at 24 weeks after ART initiation between patient who did CYP 2B6 guided EFV dose and who did not.
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
- Double (Participant, Investigator)
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
- •Anti-HIV positive
- •Naïve to antiretroviral drugs
- •Meet the criteria to start ART to Thai National guidelines
- •Sign inform consent
排除标准
- •Body mass index (BMI) >25 kg/m²
- •Pregnant women or breastfeeding
- •Received drugs that may have interaction with EFV e.g. rifampicin, fluconazole (400-800 mg), ergot alkaloid, midazolam, triazolam, ritonavir, carbamazepine, phenytoin, phenobarbitone, St John's Wort
- •Having active opportunistic infections e.g. tuberculosis, cryptococcosis, histoplasmosis, penicillosis
- •Hepatic dysfunction as indicated by:
- •Transaminases >5-10 × the upper limit of normal
- •ALP >5-10 × the upper limit of normal
- •Total bilirubin >2.5-5 × the upper limit of normal
研究组 & 干预措施
CYP2B6 guided group
Patients were assigned to perform CYP2B6 study before ART initiation. If CYP2B6 *6/*6 was found in CYP2B6 *6/*6, the patients will be initiated a low dose of 400 mg of efavirenz (2 tablets of 200 mg) with tenofovir 300 mg and lamivudine 300 mg.
干预措施: Efavirenz (Drug)
CYP2B6 guided group
Patients were assigned to perform CYP2B6 study before ART initiation. If CYP2B6 *6/*6 was found in CYP2B6 *6/*6, the patients will be initiated a low dose of 400 mg of efavirenz (2 tablets of 200 mg) with tenofovir 300 mg and lamivudine 300 mg.
干预措施: CYP450 2B6 (Other)
结局指标
主要结局
HIV RNA
时间窗: 24 weeks
次要结局
- Neuropsychiatric adverse events(24 weeks)
研究者
Pansachee DAMRONGLERD
Ramathibodi Hospital
Mahidol University