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Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men

Phase 4
Waitlist Available
Led By Anne Luetkemeyer, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is testing if taking a doxycycline pill after unprotected sex can prevent STIs like gonorrhea, chlamydia, and syphilis. The study focuses on men who have sex with men, including those with HIV and those on PrEP. Doxycycline works by killing or stopping the bacteria that cause these infections. Doxycycline has been used for the prevention of syphilis and other sexually transmitted infections, with studies showing high efficacy.

Eligible Conditions
  • Gonorrhea
  • Chlamydia
  • Syphilis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Quarterly Visits In Which an STI Was Detected

Side effects data

From 2023 Phase 4 trial • 641 Patients • NCT03980223
1%
Gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
PrEP Cohort: Control
PrEP Cohort: Doxy PEP
PLWH Cohort: Doxy PEP
PLWH: Control

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Doxy PEPExperimental Treatment1 Intervention
Doxycycline 200mg in addition to standard of care STI testing and treatment
Group II: ControlActive Control1 Intervention
The control arm will consist of standard of care STI testing and treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxycycline Hyclate Delayed-Release 200 mg
2019
Completed Phase 4
~650

Find a Location

Who is running the clinical trial?

San Francisco Department of Public HealthOTHER_GOV
37 Previous Clinical Trials
35,319 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,309 Total Patients Enrolled
7 Trials studying Gonorrhea
6,354 Patients Enrolled for Gonorrhea
University of WashingtonOTHER
1,831 Previous Clinical Trials
1,906,928 Total Patients Enrolled
11 Trials studying Gonorrhea
40,412 Patients Enrolled for Gonorrhea
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,336 Previous Clinical Trials
5,382,193 Total Patients Enrolled
32 Trials studying Gonorrhea
59,151 Patients Enrolled for Gonorrhea
Mayne Pharma International Pty LtdIndustry Sponsor
11 Previous Clinical Trials
681 Total Patients Enrolled
Anne Luetkemeyer, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
~107 spots leftby Dec 2025
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