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Doxycycline Post-Exposure Prophylaxis for STIs (DOXY-PEP Trial)
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study up to 3 months after fifth dose
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial looks at combining doxycycline with antiretrovirals to create a single-dose event-driven strategy to protect against HIV & STIs. Participants will be recruited through face-to-face & online engagements.
Who is the study for?
This trial is for healthy adults aged 18-59, not on gender-affirming hormones, who can consent to study procedures. HIV-positive participants must have an undetectable viral load and CD4 count over 300. Participants should not be pregnant or planning pregnancy, willing to use condoms and undergo biopsies. Exclusions include kidney disease, liver disease, certain medication use, allergies to study drugs, and significant lab abnormalities.
What is being tested?
The trial tests how well different oral doses of doxycycline penetrate mucosal tissues in men and women. The aim is to develop a single-dose strategy combining doxycycline with antiretrovirals (ARVs) for protection against HIV and STIs after potential exposure.
What are the potential side effects?
Doxycycline may cause side effects like stomach upset, diarrhea, sun sensitivity leading to sunburns more easily than usual; rare but serious effects include changes in vision or severe headaches.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout study up to 3 months after fifth dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study up to 3 months after fifth dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Doxycycline concentrations in rectal tissues
Doxycycline concentrations in rectal tissues after the fifth dose of doxycycline
Doxycycline concentrations in vaginal tissues
+1 moreOther study objectives
Changes in blood doxycycline concentrations in participants taking 5 doses of doxycycline.
Changes in doxycycline concentrations in penile secretions in participants taking 5 doses of doxycycline.
Changes in doxycycline concentrations in rectal secretions in participants taking 5 doses of doxycycline.
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Group I: Doxycycline 100 mgActive Control1 Intervention
Doxycycline 100mg Participants will receive the first assigned dose of Doxycycline at the clinic on days 0 and 3 at the clinic. The other three doses of the medication will be taken at home on days 7 and 1
Group II: Doxycycline 200 mgActive Control1 Intervention
Doxycycline - 200 mg Participants will receive the first assigned dose of Doxycycline at the clinic on days 0 and 3 at the clinic. The other three doses of the medication will be taken at home on days 7 and 10
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,873 Total Patients Enrolled
Centers for Disease Control and PreventionFED
888 Previous Clinical Trials
21,996,584 Total Patients Enrolled
Colleen Kelley, MD, MPHPrincipal InvestigatorEmory University
6 Previous Clinical Trials
686 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used certain medications or treatments for my condition in the last 90 days.I have kidney disease or my kidney function is low.I have hepatitis or liver disease.I am between 18 and 59 years old.I am willing to consistently use condoms during the study.I am not taking and do not plan to take doxycycline or similar antibiotics.I was assigned male or female at birth.I am HIV-positive, on stable treatment, with undetectable virus levels and a healthy immune system.I am willing to provide blood, urine, and other samples, and undergo biopsy procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Doxycycline 100 mg
- Group 2: Doxycycline 200 mg
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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