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Anti-bacterial
Doxycycline for Sexually Transmitted Infections
Phase 4
Recruiting
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
Assigned male sex or female sex at birth
Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study
Must not have
Current or chronic history of liver disease
Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours after last dose (hour 24/day 1)
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial aims to gather information on how much doxycycline is in mucosal tissues after taking it daily for a week in both males and females. The data collected will help in future studies
Who is the study for?
This trial is for adults assigned male or female at birth, in good health, and willing to use condoms. It includes HIV positive individuals with undetectable viral loads and CD4 counts over 300. Pregnant individuals or those planning pregnancy are excluded, as well as anyone planning to take doxycycline outside the study.
What is being tested?
The study tests how daily doses of doxycycline concentrate in mucosal tissues over a week to prevent bacterial STIs. Participants will provide various biological samples and undergo biopsies to gather data.
What are the potential side effects?
Potential side effects of doxycycline may include nausea, diarrhea, sun sensitivity, allergic reactions, and rarely changes in blood pressure or liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was assigned male or female at birth.
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I am not taking and do not plan to take doxycycline or similar antibiotics.
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I am willing to consistently use condoms during the study.
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I am not pregnant and do not plan to become pregnant during the study.
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I am HIV positive, on stable treatment, with undetectable virus and CD4 count over 300.
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I am willing to provide blood, urine, and other samples, and undergo biopsy procedures.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of liver disease.
Select...
I plan to use doxycycline or similar antibiotics not related to the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours after last dose (hour 24/day 1)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours after last dose (hour 24/day 1)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Doxycycline Concentration in Rectal Tissue
Doxycycline Concentration in Vaginal Tissue
Side effects data
From 2022 Phase 4 trial • 449 Patients • NCT040505403%
Malaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care Arm
dPEP Intervention Arm
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: DoxycyclineExperimental Treatment1 Intervention
Study participants taking 7 consecutive, daily doses of 100mg of Doxycycline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxycycline
2008
Completed Phase 4
~2650
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,708 Previous Clinical Trials
2,607,464 Total Patients Enrolled
16 Trials studying Sexually Transmitted Diseases
10,727 Patients Enrolled for Sexually Transmitted Diseases
Centers for Disease Control and PreventionFED
892 Previous Clinical Trials
22,000,742 Total Patients Enrolled
20 Trials studying Sexually Transmitted Diseases
65,306 Patients Enrolled for Sexually Transmitted Diseases
Colleen Kelley, MD, MPHPrincipal InvestigatorEmory University
6 Previous Clinical Trials
711 Total Patients Enrolled
2 Trials studying Sexually Transmitted Diseases
65 Patients Enrolled for Sexually Transmitted Diseases