NCT05853120CompletedPhase 4
Doxy-Post-exposure Prophylaxis
Doxy-PEP: Dose-Ranging Study of Persons Receiving Doxycycline
Source: ClinicalTrials.gov · Last updated 11 Sept 2025
Brief summary (registry, in English)
The goal of this project is to collect data regarding the ability of various oral doses of doxycycline to penetrate mucosal tissues in men and women to inform the combination of doxycycline with antiretrovirals (ARVs) for the development of single-dose event-driven multipurpose prevention strategies to protect against HIV and sexually transmitted infections (STIs). This study is of importance in the field of research because it allows the exploration of new dosing strategies that would permit a single event-driven oral dose of medications that could provide protection from HIV as well as other STIs. The study population that this study seeks to enroll are healthy people assigned male or female sex at birth and not using gender-affirming hormone therapy and are willing to undergo study procedures. Recruitment: Both face-to-face and online engagements will be conducted to recruit study participants. Face-to-face locations include bars and nightclubs, community organizations serving study populations, sports events, and community venues, and online engagements include dating sites, social networks, and craigslist, amongst other social medial platforms.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 2 May 2023
- Start date
- 31 May 2023
- Primary completion date
- 25 Sept 2024
- Lead sponsor
- Emory University
- NCT number
- NCT05853120
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 45
- From 31 May 2023 to the primary completion date, 25 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Continued need for, or use during the 90 days before 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
- 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
Other illness
- Current or chronic history of liver disease
- Known allergic reaction to study drugs.
Lab values
- Significant laboratory abnormalities at baseline visit for rectal biopsies, including but not limited to:
- Hgb ≤ 10 g/dL
- PTT \> 1.5x ULN or INR \> 1.5x ULN
- Platelet count \<100,000
Other
- Intent to use doxycycline or other tetracycline-derived antibiotics during the study, outside of the study procedures
Who the study is looking for
- Aged 18-59 years
- Assigned male sex or female sex at birth
- In good general health
- Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study
- For HIV-positive people, on stable antiretroviral therapy with an undetectable viral load and CD4 count\> 300ul/ml
- Willing to use condoms consistently for the duration of the study
- Able to provide informed consent
- No plans for relocation in the next 4 months
- Not pregnant and does not plan on getting pregnant for the duration of the study
- 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
Age in the registry: 18 years to 59 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hope Clinic Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.