EUCTR2012-003778-16-GB进行中（未招募）1 期
A phase IV study to determine the oral and genital tract concentration of Maraviroc required for ex vivo protection from HIV-1 using Maraviroc 300mg stat - Pharmacokinetic and pharmacodynamic study investigating the role of Maraviroc 300mg in protection fr
Guy's & St. Thomas' NHS Foundation Trust0 个研究点目标入组 58 人开始时间: 2013年4月5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
- 58
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
入选标准
- •1.The ability to understand and sign a written informed consent form prior to participation in any screening procedures and must be willing to comply with all trial requirements.
- •2.Male or non-pregnant, non-lactating females
- •3.Age between 18 to 50 years, inclusive.
- •4.Body Mass Index (BMI) of 16 to 35 kg/m2, inclusive.
- •5.Negative antibody/antigen combined test for HIV-1 and HIV-2.
- •6.Absence of any significant health problems (in the opinion of the investigator) on the basis of the screening procedures; including medical history, physical examination, vital signs.
- •7.Willing to consent to their personal details being entered on to The Overvolunteering Prevention Scheme (TOPS) database.
- •8.Women participating in sexual intercourse that could result in pregnancy must use an adequate form of contraception throughout the study and for two weeks after the study. This includes intrauterine device, condoms, anatomical sterility in self or partner . Oral hormonal methods and implant contraceptives are allowed but only in combination with the additional protection of a barrier method.
- •9.Female participants may not use any vaginal products or objects or have vaginal sex for 48 hours before and after the collection of vaginal fluid and vaginal biopsies. This list includes tampons, female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method),douches, lubricants, vibrators/dildos, and drying agents.
- •10.Males participating in sexual intercourse that could result in pregnancy must use condoms during the duration of the study.
- •11.Men cannot use anal products or objects including but not exclusive to douches, lubricants and vibrators/dildos, butt plugs or urethral sounds or have receptive anal intercourse for 48 hours before and after the collection of rectal fluid and rectal biopsies.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Any significant acute or chronic medical illness as determined by the investigator..
- •2.Evidence of organ dysfunction or any clinically significant deviation from normal
- •in physical examination, vital signs or clinical laboratory determinations.
- •3.Positive blood screen for syphilis, hepatitis B (HBs Ag) and/or C antibodies.
- •4.Positive blood screen for HIV-1 and/or HIV-2 antibodies by 4th generation assay.
- •5.Positive screen for sexually transmitted infections at screening visit
- •6.High-risk behaviour for HIV-1 infection which is defined as having one of the
- •following within three months before trial day 0 (first dose):
- •i.had unprotected vaginal or anal sex with a known HIV-1 infected person or a casual partner.
- •ii.engaged in sex work for money or drugs.
- •iii.acquired a bacterial sexually transmitted disease.
- •iv.having a known HIV-1 positive partner either currently or in the previous six months
- •7.Females who are pregnant or breast-feeding.
- •8.Clinically significant laboratory abnormalities
- •9.Known hypersensitivity to peanut or soya, to the active substance or any of the excipients
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