Treatment Switch From Efavirenz to Rilpivirine in Virologically-suppressed HIV-infected Thai Adolescents
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 主要终点
- Proportion of adolescents with HIV-RNA <50 copies/ml at 48 weeks after switching.
研究概览
简要总结
To describe the immunologic and virologic outcomes (HIV RNA, CD4) following switching from EFV to RPV in virologically suppressed adolescents
详细描述
Study Procedures:
At screening, the informed consent process will be provided to participant, or participant legally acceptable representatives before any study procedure. Only adolescents who know their HIV status will be asked to give assent.
Twenty adolescents followed at HIV-NAT and the Department of Pediatrics, Faculty of Medicine, Chulalongkorn University will be asked to participate in the PK sub study. Participant who are enrolled in the PK substudy will be asked to take RPV in the morning after breakfast and then commence the PK evaluations after this witnessed dose. After the PK study at week 4, Participant will be followed with the other 80 adolescents until the end of the study. Participant will be asked to provide a small hair sample for RPV concentrations at weeks 4, 12, 24, and 48 after switching. This is an option therefore participant can refuse to provide their hair samples at any visits. HIV RNA levels will be performed at baseline, week 12, 24 and 48 visits. If the HIV-RNA at any visits is between >50 copies/ml, the HIV-RNA test will be repeated within 4-8 weeks with adherence improvement counseling. At any visit, if HIV-RNA is ≥1000 copies/ml, genotypic resistance testing will be performed. Modification of treatment both for resistance and safety consideration will be subject to the site principal investigator's decision.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected adolescents aged 12-18 years;
- •Body weight >25 kilograms;
- •Currently treated with stable EFV-based HAART (EFV plus two nucleoside or nucleotide reverse transcriptase inhibitors [N(t)RTI]) for >3 months prior to enrollment;
- •Plasma HIV RNA <50 copies/ml within the last 12 months;
- •ALT <200 IU/L within the last 12 months;
- •Caregivers give written informed consent and adolescents who know their HIV status (i.e., have been fully disclosed to) give assent
排除标准
- •Has evidence of NNRTI-associated resistance mutation(s) from previous genotypic resistance testing;
- •Currently has PI(s) in the HAART regimen;
- •Has currently active HIV-related infection(s), (The subject can be enrolled after the infection is under controlled);
- •Has significant medical problem(s) that would compromise study results (in the site principal investigator's opinion);
- •Pregnancy (postpartum women are allowed);
- •Concomitant treatment with drugs known to effect the PK of RPV (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin, omeprazole, esomeprazole, lansoprazole, erythromycin, clarithromycin, azithromycin, roxithromycin)
研究组 & 干预措施
opened label
Open-label, single-arm study, rilpivirine is the study drug
干预措施: Rilpivirine (Drug)
结局指标
主要结局
Proportion of adolescents with HIV-RNA <50 copies/ml at 48 weeks after switching.
时间窗: 48 weeks
次要结局
- Change in fasting blood sugar after switching to RPV-containing regime(Baseline, week 24, and week 48)
- Change in quality of life (QOL) score(Baseline, week 4 and week 24)
- Intensive PK parameter (Area under the plasma concentration-time curve; AUC0-24) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.(week 4)
- Change in neuropsychiatric test scores(Baseline and week 24)
- Intensive PK parameter (maximum observed concentration of drug in plasma ;(Cmax) ) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.(week 4)
- Change in lipid profiles after switching to RPV-containing regimens(Baseline, week 24, and week 48)
- Intensive PK parameter (Minimum concentration of drug in plasma; (Ctrough)) of RPV in 20 subjects at 4 weeks after switching to RPV-containing regimens.(week 4)
- Description of resistance mutations in the adolescents with RPV treatment failure(baseline, week 12, week 24 and week 48)