CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 45 enrolled
Drug / intervention
Doxycyclinedrug
Likely dose
Doxycycline 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05853120
NCT05853120Phase 4Completed

Doxy-PEP: Dose-Ranging Study of Persons Receiving Doxycycline

Emory University·interventional·Posted May 10, 2023·Updated Sep 11, 2025

In Brief

A Phase 4 clinical trial evaluating Doxycycline for Sexually Transmitted Diseases. Completed, enrolled 45 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
202420252026
First PostedMay 10, 2023
Enrollment StartMay 31, 2023
Primary CompletionSep 25, 2024
Study CompletionDec 24, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.1 years ago

Interventions

Doxycyclinedrug

Doxycycline is used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections. Doxycycline (DOX) will be given orally at 100 and 200 mg doses.