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New treatment option for Sexually Transmitted Infections (STI)
Official title Got Doxy- 'Flipping the Script' on STI PEP
ClinicalTrials.gov ID: NCT07215325
What this study is testing
What is Doxycycline monohydrate 200 mg?
Doxycycline monohydrate 200 mg is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for sexually transmitted infections (sti).
Also referred to as Doxycycline.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is being done to test the effects of doxycycline on inflammation and the bacteria in the body in people with HIV and in people on HIV pre-exposure prophylaxis. This drug is approved by the Food and Drug Administration (FDA) for the treatment of bacterial infections.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only. Healthy volunteers may be eligible.
You may be able to join if
- Age \>18 years
- Assigned male sex at birth
- Good general health as assessed by a clinician at the screening study visit
- For people with HIV, on suppressive antiretroviral therapy for at least 6 months with the most recent viral load documented \ 300cells/ul
- For people without HIV, taking oral daily, oral on-demand, or injectable pre-exposure prophylaxis for at least 3 months at the time of enrollment...
You likely can't join if
- Severe/uncontrolled comorbidities that could influence immune outcomes (e.g., diabetes, hypertension, co-infections), as assessed by the investigator.
- History of inflammatory bowel disease (IBD) or other inflammatory, infiltrative, infectious, or vascular condition involving the lower GI tract that...
- Known allergy to doxycycline
- Use of any antibiotics within 3 months before screening
- Significant lab abnormalities at baseline visit for rectal biopsies,
- Continued need for the following medications during the study:
See the full eligibility criteria
- Age \>18 years
- Assigned male sex at birth
- Good general health as assessed by a clinician at the screening study visit
- For people with HIV, on suppressive antiretroviral therapy for at least 6 months with the most recent viral load documented \ 300cells/ul
- For people without HIV, taking oral daily, oral on-demand, or injectable pre-exposure prophylaxis for at least 3 months at the time of enrollment, with plans to continue for the duration of the study
- Additional criteria apply
- Severe/uncontrolled comorbidities that could influence immune outcomes (e.g., diabetes, hypertension, co-infections), as assessed by the investigator.
- History of inflammatory bowel disease (IBD) or other inflammatory, infiltrative, infectious, or vascular condition involving the lower GI tract that, in the judgment of the investigators, may be worsened by study...
- Known allergy to doxycycline
- Use of any antibiotics within 3 months before screening
- Significant lab abnormalities at baseline visit for rectal biopsies,
- Continued need for the following medications during the study:
- Aspirin
- Warfarin, heparin (LMW or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents
- Any form of rectally administered agent besides products (lubricants or douching) used for sexual intercourse
- NSAIDS within 72 hours of rectal sampling procedures
- Continued need for, or use during the 90 days before enrollment, of the following medications:
- Systemic immunomodulatory agents
- Supraphysiologic doses of corticosteroids, except for short-course corticosteroids \<7 days duration at the discretion of the investigator. (Gender affirming hormone therapy is not exclusionary.)
- Use of experimental medications, vaccines, or biologicals in the 12 months before enrollment
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.