CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
Doxycycline +1 moredrug
Likely dose
Doxycycline 100mgfrom 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/NCT02864550
NCT02864550Phase 4Completed

A Randomized, Placebo-controlled Trial of Oral Doxycycline for the Prevention of Syphilis in HIV-positive Men Who Have Sex with Men (MSM)

British Columbia Centre for Disease Control·interventional·Posted Aug 12, 2016·Updated Feb 12, 2025

In Brief

A Phase 4 clinical trial evaluating Doxycycline and Placebo for Syphilis and Sexually Transmitted Infections. Completed, enrolled 52 participants across 1 site.

Detailed Summary

Syphilis is a sexually transmitted infection (STI) disproportionately affecting gay, bisexual and other men who have sex with men (gbMSM), with the potential for significant sequelae - particularly in those who are Human Immunodeficiency Virus (HIV)-positive. Rising rates of this STI have prompted a search for novel prevention solutions. A recent pilot study of daily doxycycline prophylaxis demonstrated promise as a novel STI prevention tool. This innovative approach to STI prevention has solid clinical precedent, both from the HIV pre-exposure prophylaxis (PrEP) literature, as well as doxycycline's use as prophylaxis for other infections. The overarching goal of this project is to determine whether the daily use of doxycycline is an efficacious and acceptable intervention for syphilis prevention in high-risk, HIV-positive gbMSM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 12, 2016
Enrollment StartAug 15, 2019
Primary CompletionApr 5, 2024
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 9.9 years ago

Interventions

Doxycyclinedrug

doxycycline 100mg orally daily

Placeboother

placebo capsule identical in appearance, taste, and size to the capsule provided to the intervention group