EUCTR2017-004750-42-ES进行中（未招募）1 期
EFFICACY AND SAFETY OF A SIMPLIFICATION STRATEGY BASED ON DOLUTEGRAVIR AND DARUNAVIR / COBICISTAT VS OPTIMIZED TREATMENT IN SUPPRESSED HIV-1-INFECTED PATIENTS CARRYING ARCHIVED MULTIDRUG RESISTANCE MUTATIONS
FUNDACIÓ LLUITA CONTRA LA SIDA0 个研究点目标入组 100 人开始时间: 2018年6月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. HIV-1 infected patients (=18 years).
- •2. Confirmed plasma HIV-1 RNA levels < 50 copies/ml for = 6 months preceding the study randomization.
- •3. Currently ART containing at least 3 of the following antiretroviral drugs for = 6 consecutive months preceding the study randomization: 3TC, FTC, ABC, ZDV, DDI, TDF, TAF, LPV/r, ATV/r, ATV/c, DRV/r, DRV/c, EFV, NVP, ETR, RPV, RAL, ELV/cobi or MVC.
- •4. Must have historical genotyping tests showing DRM associated with at least two antiretroviral classes according to Stanford dB.
- •5. Willing and able to be adherent to their cART regimen for the duration of the study (in opinion of physician).
- •6. If heterosexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner*) from 14 days prior to study inclusion and at least 12 weeks after the end of the study; all female volunteers must be willing to undergo urine pregnancy tests at time points specified in the Schedule of Procedures.
- •7. If heterosexually active male; willing to use an effective method of contraception (anatomical sterility in self) or agree on the use of an effective method of contraception by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility*) from the day of the study inclusion until 12 weeks after the end of the study.
- •8. Signed informed consent
- •* condom use nor diaphragma are considered as an additional method of contraception only and cannot be the only method of contraception used as not been considered an effective method by the Clinical Trial Facilitation Group (CTFG) guidelines.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with any DRM associated to INSTI (i.e. T66I, 74M, E92Q, T97A, F121Y, E138A/K, G140A/S, Y143R/H/C, S147G, Q148H/K/R, N155H AND R263K) in historical genotyping tests.
- •2. Patients with any evidence of previous virologic failure to INSTI-based regimens (with or without drm in the integrase).
- •3. Patients who have experienced previous uncontrolled interruptions of INSTI-based regimens.
- •4. Patients who have archived DRM conferring a low – or higher - level of resistance to DRV/cobi (>15 points from Stanford dB score) .
- •5. Patients with unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones)
- •6. Patients with severe heaptic impairment (class C) according to the Child-Pugh classification
- •7. Patients with alanine aminotransferase (ALT) = 5 times upper normal limit (ULN) or ALT = 3 times ULN and bilirubin = 1.5 times ULN.
- •8. Patients with hepatitis C co-infection that would require therapy during the study.
- •9. Patients with hepatitis B surface antigen (HBsAg) positive.
- •10. Known allergy to the study drugs or their components.
- •11. Current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study.
- •12. Females who are pregnant or breastfeeding.
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