NCT04076423已完成4 期
A Phase IV, Multicenter, Open and Randomized Study to Assess the Impact of the Change From Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With Type 1 HIV Infection. InSTINCT Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 18
- 主要终点
- sCD14
研究概览
简要总结
242 patients (121 patients in each of the two treatment arms) will be included with a confirmed diagnosis of HIV-1 infection and with a stable antiretroviral treatment during more than 48 weeks with dual therapy (DTG + 3TC)
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
- 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
- •Men and women ≥ 18 years
- •Confirmed and documented diagnosis of HIV-1 infection
- •Virological suppression of more than 48 weeks (confirmed with HIV RNA <50 copies / ml). The determination of the CV of a routine prior analysis of ≤ 12 weeks prior to signature of consent.
- •ART in stable dual therapy (> 48 weeks) with DTG + 3TC
- •Signed informed consent
- •Negative pregnancy test in urine or blood
排除标准
- •Inability to obtain written informed consent to participate in the study
- •Pregnant or breastfeeding women or those who intend to become pregnant during the study period and do not undertake to use proven contraceptive methods.
- •Any suspicion or confirmation of resistance to TAF, 3TC, FTC, DTG or BIC. In case of have a study of baseline resistance mutations prior to the start of ART has to rule out resistance to investigational drugs.
- •Patients with hypersensitivity to any excipient used with TAF, FTC, DTG or BIC
- •Any chronic autoimmune or inflammatory disease
- •Use of immunomodulatory or immunosuppressive agents, including steroids Chronic treatment with aspirin, statins and other anti-inflammatory agents
- •Any acute infection in the last 2 months
- •Estimated glomerular filtration rate (TFGe) <30 mg / ml / m2 measured by any of the formulas available. The determination of the TFGe of a previous routine analysis of ≤ 12 weeks prior to signing the consent is allowed
- •Contraindication for the use of TAF
- •Clinical condition of the patient in rapid deterioration or the investigator considers that there is no reasonable hope that the patient will finish the study
- •Simultaneous participation in another clinical trial or research study that requires the need of treatment with other drugs outside the study or interfere with the visits of the same.
- •Any situation that, in the opinion of the investigator, may interfere with the patient's ability to meet the treatment schedule and protocol evaluations
研究组 & 干预措施
Experimental arm:
Experimental
they will take 1 tablet (50 mg BIC + 200 mg FTC + 25 mg TAF), orally, once a day, from the moment of randomization.
干预措施: Triple therapy (Drug)
Comparator arm
Active Comparator
they will take 1 tablet of 50 mg of DTG orally, once a day + 1 tablet of 300 mg of 3TC orally, once a day, from the randomization moment.
干预措施: Dual Therapy (Drug)
结局指标
主要结局
sCD14
时间窗: Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96
Changes in sCD14 concentration
次要结局
- Changes in quinurenine / tryptophan ratio(Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96)
- Changes in PCR-us(Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96)
- Changes in sCD163(Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96)
- Changes in Dimer D(Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96)
- Changes in CD4+(Throughout all the study, an average of 100 weeks)
- Changes in CD4/CD8 ratio(Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96)
- Changes in viral suppression rates(Throughout all the study, an average of 100 weeks)
- Longitudinal trajectories of plasma biomarkers(Throughout all the study, an average of 100 weeks)
- Longitudinal trajectories of CD4/CD8 ratio(Throughout all the study, an average of 100 weeks)
研究者
研究点 (18)
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