ISRCTN23353517已完成1 期
A randomised, double blind phase I study to assess the safety, pharmacokinetics and pharmacodynamics of single and 14 days dosing with two vaginal microbicide formulations containing either Darunavir, or Dapivirine and Darunavir.
York Hospital NHS Trust0 个研究点目标入组 24 人开始时间: 2015年2月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- Female
入选标准
- •1. Available for the duration of the study
- •2. Willing and able to give written informed consent
- •3. In good health as determined by medical history, physical examination, results of screening tests and the clinical judgment of a medically qualified investigator
- •4. Judged, in the opinion of a medically qualified investigator, to be able and likely to comply with all study requirements as set out in the protocol
- •5.Willing to undergo screening for HIV, Hepatitis B, Hepatitis C and sexually transmitted infections (Chlamydia, Gonorrhoea and Trichomonas)
- •6. Willing to abstain from vaginal practices including sexual intercourse and receptive oral sex from 48 hours before any given dose and up to 72 hours after
- •7. Willing to abstain from using any genital preparations other than the study gel during the period of gel administration and until the final follow up visit
- •8. Willing to abstain from using tampons during the two periods of gel administration
- •9. Willing to refrain from blood donation for the duration of the study
- •10. If fertile, using a reliable method of contraception for the 3 to 4 menstrual cycles covering the cycles pre study, during study dosing and until the final follow up visit has been completed. For the purposes of this trial only the following will be accepted as a reliable form of contraception:
- •10.1. Consistent use of condoms with every act of sexual intercourse
- •10.2. Combined oral contraceptive pill
- •10.3. Desogestrel containing progesterone only pill (Cerazette)
- •10.4. Intrauterine contraceptive device or system
- •10.5. Injectable contraceptive or progesterone implant
- •11. Willing to undergo a urinary pregnancy test at screening, on the day of randomisation, on the day of receipt of the second dose of the microbicide and at the final follow up visit
- •12. Have been registered with a General Practitioner (GP) for at least the past 3 months and willing to allow the investigators to discuss the volunteer’s medical history with their GP prior to randomisation
- •13. Agree to registration on a national database of trial subjects to prevent overvolunteering (TOPS), and to the taking of a photograph to be kept at the trial site
- •14. Upper Age Limit 50 years ; Lower Age Limit 18 years
排除标准
- •Untreated syphilis, gonorrhoea, trichomonas, chlamydia, vaginal candidosis or bacterial vaginosis (participants who test positive for any of these infections and are subsequently treated will be eligible provided all other inclusion criteria are met)
- •1. Seropositive for hepatitis B surface antigen (HBsAg) or Hepatitis C (antibodies to HCV) or HIV
- •2. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- •3. Abnormal findings on pelvic examination, deemed clinically significant by a medically qualified investigator
- •4. Irregular menstrual bleeding likely to cause vaginal bleeding during the dosing period as judged by a medically qualified investigator
- •5. Treatment for CIN or other gynaecological instrumentation of the cervix within the last 3 months
- •6. An allergy to parabens or any of the other IMP constituents
- •7. Insertion of an intrauterine contraceptive device or system within the last 6 weeks
- •8. Any other significant disease, disorder or finding, which, in the opinion of a medically qualified investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer’s ability to participate in the study
- •9. Participation in another research study involving an investigational product in the 3 months preceding enrollment, or planned use during the study period
- •10. Pregnant, less than 12 weeks postpartum, lactating or willingness/intention to become pregnant during the study
- •11. Significant concern raised by GP in relation to participation
- •12. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required inparticipation and consent
- •13. Unlikely to comply with the study protocol
研究者
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