Using doxycycline to prevent sexually transmitted infections after unprotected sex

Caractérisation de la pharmacocinétique d'Une Dose Unique de 200 mg de Doxycycline en Prophylaxie Post-exposition (PEP) Des Infections Sexuellement Transmissibles Dans différents Compartiments Biologiques

This study is testing if a single dose of doxycycline can help prevent sexually transmitted infections in men who have sex with men after unprotected sex while they are already taking HIV prevention medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 100 Years
• Sex: Male
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 2 sites (Paris and 1 other locations)
• Trial ID: NCT06007534 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetics of a single 200 mg dose of doxycycline administered as post-exposure prophylaxis (PEP) to prevent sexually transmitted infections (STIs) in men who have sex with men (MSM) on pre-exposure prophylaxis (PrEP) for HIV. The research focuses on measuring drug concentrations in various biological compartments to assess adherence to the PEP regimen. By monitoring doxycycline levels in plasma and hair samples, the study aims to provide a more accurate measure of adherence compared to self-reporting. The findings could help improve the effectiveness of PEP strategies among high-risk populations.

Who should consider this trial

Good fit: Ideal candidates for this study are adult male patients who are MSM on PrEP or HIV-infected individuals with a recent history of risky sexual intercourse.

Not a fit: Patients who have symptoms of bacterial STI infections or those who have taken doxycycline in the past three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of STIs in high-risk populations, enhancing public health outcomes.

How similar studies have performed: Other studies have shown promising results with doxycycline as PEP for STIs, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Adult male patient
* Men who have Sex with Men (MSM) on PrEP or HIV-infected patients
* Patients who have not taken doxycycline for at least 3 months
* No symptoms of bacterial STI infection (chlamydia, gonorrhea, Mycoplasma genitalium or syphilis).
* Documented history of bacterial STI infection within the past 12 months
* Having had a risky intercourse within 24 hours and at the latest within 72 hours and for which a prescription of doxycycline in a single dose of 200 mg has been made within the framework of his usual follow-up.
* Free, informed, written consent, signed by the person and the investigator at the latest on the day of inclusion and before any examination carried out within the framework of the study (article L1122-1-1 of the Public Health Code).
* Person affiliated or benefiting from a social security system (article L1121-11 of the Public Health Code)

Exclusion Criteria:

* Systemic treatment with retinoids (Acnetrait®, Procuta®, Curacné®, Contracné®, ....).
* Treatment with enzyme-inducing anticonvulsants (carbamazepine, phenobarbital, phenytoin, etc.).
* Known allergy to antibiotics of the tetracycline family.
* Known allergy to one of the components of doxycycline tablets.
* Documented esophageal injury
* Ongoing treatment with doxycycline at the time of inclusion.
* Person participating in another research study with an exclusion period still in progress at inclusion.
* Persons under guardianship, conservatorship, or deprived of liberty by judicial or administrative decision.
* Patients on State Medical Aid

Where this trial is running

Paris and 1 other locations

• Hôpital Lariboisière AP-HP — Paris, France (Recruiting)
• Hôpital Saint Louis AP-HP — Paris, France (Recruiting)

Study contacts

• Study coordinator: Lauriane GOLDWIRT, Dr

Conditions Post-exposure Prophylaxis; Sexually Transmitted Diseases; Doxycycline