Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens

Completed · Phase 4

Conditions studied: Sexually Transmitted Diseases

In brief

The study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (STI) Post-exposure Prophylaxis (PEP).

Key facts

Study ID

NCT04860505

Run by

Emory University

People needed

20

Starts

2021-05-20

Expected to finish

2022-05-09

Last updated by the study team

2023-05-23

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hope Clinic — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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