PACTR201809520959443暂停1 期
A phase I/II trial to assess the safety, acceptability, tolerability and pharmacokinetics of a sustained-release tenofovir alafenamide sub-dermal implant for HIV prevention in women
Centre for the AIDS Programme of Research in Sauth Africa0 个研究点目标入组 550 人开始时间: 2018年9月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 550
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
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- Female
入选标准
- •Age 18-40 years (Phase I participants)
- •Age 18-30 years (Phase II participants)
- •Able and willing to provide written informed consent
- •Able and willing to provide adequate locator information for study retention purposes
- •HIV-negative on testing performed by study staff
- •Negative pregnancy test performed by study staff
- •Agree to use a reliable non-barrier form of contraception during the study and for at least 14 days before enrolment and until 30 days after implant removal (even if not currently sexually active)
- •In general, be in good health, as assessed clinically
- •Phase I participants must be at low risk of HIV infection
排除标准
- •Pregnant or currently breastfeeding, or intends to become pregnant and/or breastfeed during the study
- •Intends relocation from current residential area in the next 12 months
- •Haemoglobin < 9.5 g/dL
- •Alanine aminotransferase (ALT) > the upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) > ULN
- •Creatinine clearance < 60 mL/min (Cockcroft and Gault estimation)
- •Hepatitis B surface antigen (HBsAg) positive
- •LDL or triglycerides or total cholesterol > ULN from a random sample
- •Past (< 6 months ago) or current participation in any other research study which may interfere with this study
- •Currently on tenofovir-containing oral PrEP drugs
- •Currently has a contraceptive implant, only if this would make it difficult to insert the study implant
- •Has a tattoo or other dermatological condition overlying the inner arm which in the opinion of the Principal Investigator or designee, may interfere with interpretation of insertion site reactions
- •Bleeding abnormality or on anti-coagulants
- •Active or planned use of prohibited medications as described in the Study Specific Procudures manual (updated regularly from the OCIS-001 Investigator’s Brochure)
- •Has any other condition that, based on the opinion of the Principal Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
研究者
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