Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plasma Doxycycline Concentration
研究概览
简要总结
The study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (STI) Post-exposure Prophylaxis (PEP).
详细描述
To determine tissue pharmacology of a single dose of doxycycline for STI PEP, investigators at Emory University will collaborate with the Centers for Disease Control and Prevention (CDC) to conduct a clinical trial of up to 20 men who have sex with men (MSM) and women aged 18-59, with measurement of anti-retroviral drug and doxycycline concentrations in the rectum and vaginal regions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV negative person, who was assigned male or female at birth, who reports sex with another man in the last year and is in good general health
- •Aged 18-59 years
- •Not currently taking PrEP and no plans to initiate during study
- •Not currently taking PEP
- •Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study
- •Willing to use condoms consistently for the duration of the study
- •Able to provide informed consent in English
- •No plans for relocation in the next 4 months
- •Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure
- •Willing to use study products as directed
- •Hepatitis B surface antigen (HBsAg) negative (screening lab test)
- •Creatinine clearance >60 ml/min
排除标准
- •Currently infected with hepatitis virus and/ or has liver disease
- •Current or chronic history of kidney disease or creatinine clearance (CrCl)<60 ml/min
- •Continued need for, or use during the 90 days prior to enrollment, of the following medications:
- •Systemic immunomodulatory agents
- •Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators)
- •Chemotherapy or radiation for treatment of malignancy
- •Experimental medications, vaccines, or biologicals
- •Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) during the study, outside of the study procedures
- •Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures
- •Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements
- •Not pregnant and no plans on getting pregnant throughout the duration of the study
- •Known allergic reaction to study drugs
研究组 & 干预措施
Doxycycline and Biktarvy
Participants will take both study drugs simultaneously at home approximately 1 hour before Visit 2 and will be instructed to take a timestamped photograph or videotape of themselves taking the dose.
干预措施: Doxycycline (Drug)
Doxycycline and Biktarvy
Participants will take both study drugs simultaneously at home approximately 1 hour before Visit 2 and will be instructed to take a timestamped photograph or videotape of themselves taking the dose.
干预措施: Biktarvy (Drug)
结局指标
主要结局
Plasma Doxycycline Concentration
时间窗: 24 hours after a single dose
Doxycycline concentration in plasma was measured.
Vaginal Doxycycline Concentration
时间窗: 24 hours after a single dose
Doxycycline concentration in tissue from a vaginal biopsy was measured.
Rectal Doxycycline Concentration
时间窗: 24 hours after a single dose
Doxycycline concentration in tissue from a rectal biopsy was measured. Rectal biopsies were obtained from men. Women had the option to provide a rectal tissue sample.
次要结局
- Vaginal Bictegravir Concentration(24 hours after a single dose)
- Rectal Bictegravir Concentration(24 hours after a single dose)
研究者
Colleen Kelley
Associate Professor
Emory University