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Antiretroviral

Doxycycline for Sexually Transmitted Infections

Phase 4
Waitlist Available
Led By Colleen Kelley, MD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-59 years
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours after a single dose
Awards & highlights

Study Summary

This trial will study how well doxycycline works to prevent STIs when taken as PEP.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours after a single dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after a single dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma Doxycycline Concentration
Rectal Doxycycline Concentration
Vaginal Doxycycline Concentration
Secondary outcome measures
Rectal Bictegravir Concentration
Vaginal Bictegravir Concentration

Side effects data

From 2021 Phase 4 trial • 26 Patients • NCT04167085
4%
Sinus infection
4%
Foot infection
4%
Metastatic lung cancer dx
4%
Blurred vision
4%
Emesis
4%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Doxycycline
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Doxycycline and BiktarvyExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emtricitabine
FDA approved
Doxycycline
FDA approved

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,627 Previous Clinical Trials
2,560,727 Total Patients Enrolled
Centers for Disease Control and PreventionFED
873 Previous Clinical Trials
22,467,560 Total Patients Enrolled
Colleen Kelley, MD, MPHPrincipal Investigator - Emory University
Grady Memorial Hospital, Ponce De Leon Center-Infectious Disease
Emory University School Of Medicine (Medical School)
University Ca Sf School Of Medicine (Residency)
5 Previous Clinical Trials
691 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Mar 2025