ISRCTN18166185已完成2 期
A feasibility study to assess the effects of AntiretroViral Intensification with Cenicriviroc for the management of HIV-associated Cognitive Impairment
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 or over at screening, male or female subjects
- •2. Documented HIV-infected
- •3. Undetectable plasma HIV RNA (<200 copies/mL) for at least 6 months
- •4. Demonstrated clinically significant cognitive impairment
- •5. On cART comprising of BHIVA guideline recommended therapies (2015 guidelines) with the exception of elvitegravir/cobicistat and rilpivirine
- •6. Comorbidities, if present, are stably managed for at least 6 months
- •7. No clinically significant recreational drug use or alcohol dependence
- •8. Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom and diaphragm) during heterosexual intercourse, from screening through completion of the study
- •9. Female subjects may be eligible to enter and participate into the study if she:
- •9.1. Is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and = 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy
- •9.2. Is of child-bearing potential with a negative pregnancy test at both Screening and Day 0 and agrees to use one of the following methods of contraception to avoid pregnancy:
- •9.2.1. Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of study drug, throughout the study, and for at least 2 weeks after discontinuation of all study medications
- •9.2.2. Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
- •9.2.3. Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion)
- •9.2.4. Male partner sterilization confirmed prior to the female subject’s entry into the study, and this male is the sole partner for that subject
- •9.2.5. Approved hormonal contraception
- •9.2.6. Any other method with published data showing that the expected failure rate is <1% per year
- •Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of study medication.
排除标准
- •1. Current major depression (score of less than 15 on PHQ-9 score at study screening)
- •2. Chronic neurological diseases (e.g., epilepsy and stroke; at the discretion of the investigator)
- •3. History of severe head injury (with loss of consciousness for >30 minutes)
- •4. Cerebral AIDS defining infections
- •5. Current intravenous drug use (past six months)
- •6. Severe psychiatric disease (at the discretion of the investigator)
- •7. Contra-indication for MRI scan (e.g., claustrophobia, metal in body, physically unable to lie flat)
- •8. Contraindications to lumbar-puncture examination (at the discretion of the investigator)
- •9. Current or previous use of CCR5 inhibitors (maraviroc, cenicriviroc or others)
- •10. Disallowed medication which may interact with cenicriviroc
- •11. Chronic liver disease
- •12. Laboratory investigations at screening out with the follow cut-offs:
- •12.1. Haemoglobin < 8.5 g/dL
- •12.2. Absolute neutrophil count < 1000
- •12.3. Platelet count < 100,000
- •12.4. ALT or AST> 5 x upper limit of normal
- •12.5. Estimated creatinine clearance < 50 mL/min (Cockcroft and Gault 1979)
- •13. In the opinion of the investigator unable to comply with study procedures
研究者
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