Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.
试验速览
- 阶段
- 2 期
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks
研究概览
简要总结
Phase IIa, open clinical trial, pilot, single arm and proof of concept.
详细描述
Proof of concept trial evaluating safety and efficacy of treatment with Dolutegravir (DTG) + lamivudine (3TC) once daily in suppressed participants with history of previous treatment with 3TC or emtricitabine (FTC). Half of the participants will have history of failure with 3TC or FTC and M184V/I or K65R/E/N mutations in previous plasma genotypes, although to be eligible these mutations cannot be detectable at study entry in proviral DNA.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected patients.
- •Age> 18 years.
- •Receiving stable antiretroviral treatment for at least 3 months.
- •Current or historical treatment with 3TC or FTC.
- •Willing to change antiretroviral treatment due to intolerance or interest in simplification.
- •Undetectable viral load (<50 cop/mL) for at least 1 year prior to the inclusion. A single viral load >50cop/ml (≤500 copies/ml) is allowed before the three months prior to inclusion in the study, preceded and followed by an undetectable determination.
- •Current level of CD4> 350 cells/μL.
- •Naïve to integrase inhibitors.
- •Patient able to understand and give written informed consent.
- •For those included in group 1 (20 patients): No previous history of virological failure with ART regimen that included 3TC or FTC or previous virological failure had a population genotype without M184V/I or K65R/E/N mutations.
- •For those included in group 2 (20 patients): previous history of virological failure with ART regimen that included 3TC or FTC and historical genotype with M184V/I or K65R/E/N mutations.
排除标准
- •Detection of any of the following mutations in proviral DNA in peripheral blood by conventional sequencing: M184V/I or K65R/E/N.
- •Pregnant, lactating or child-bearing women who do not commit to using an adequate contraceptive method.
研究组 & 干预措施
Dolutegravir (DTG) + Lamivudine (3TC)
Eligible subjects will receive one 50 mg tablet of DTG plus 300 mg 3TC tablet orally once daily upto 48 weeks
干预措施: Dolutegravir (DTG) (Drug)
Dolutegravir (DTG) + Lamivudine (3TC)
Eligible subjects will receive one 50 mg tablet of DTG plus 300 mg 3TC tablet orally once daily upto 48 weeks
干预措施: Lamivudine (3TC) (Drug)
结局指标
主要结局
Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks
时间窗: Week 48
- Efficacy: Proportion of patients with undetectable viral load (\<50 copies / mL) at 48 weeks of follow-up, according to the FDA snapshot algorithm in the population "by intention to treat-exposed". The intention-to-treat population includes all patients who have received at least one dose of DTG and 3TC.
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Since baseline visits to week 48)
- Evaluation of the appearance of genotypic resistance mutations (1)(Week 48)
- Proportion of patients with virological failure at 24 weeks(Week 24)
- Proportion of patients with virological failure at 48 weeks(Week 48)