EUCTR2014-003874-17-IT进行中（未招募）1 期
Antiretroviral Pre-exposure prophylaxis for natural conception (PrEP-C) in serodiscordant female partners of HIV-infected men in sustained virologic suppression
ational Institute for Infectious Diseases Lazzaro Spallanzani IRCCS0 个研究点目标入组 30 人开始时间: 2014年9月26日最近更新:
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
- 30
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
- Female
入选标准
- •Age> 18 years (couple)
- •HIV infected male partner on ARV treatment with plasma HIV RNA <40 copies / mL for at least 6 months
- •Test HIVAb / Ag negative (female partner)
- •No unprotected sex with HIV infected partner (female partner) or with other partners (couple) in the last 30 days
- •Absence of sexually transmitted disease or infection (couple)
- •Signing of Informed Consent (couple).
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Female partner:
- •Hepatitis B or nephropathy
- •Presence of contraindications for Truvada as specified in the leaflet indications
- •Use of psychoactive substances that may interfere with the patient's adherence to the prescribed medication regimen
- •Participation in other Clinical Trial
- •Subjects who, in the opinion of the investigator, does not ensure appropriate adherence to the study
- •Inability to sign the informed consent.
- •Signature of consent only by the female partner.
研究者
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