Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments

Not Applicable

Recruiting

• Conditions: Post-exposure Prophylaxis; Sexually Transmitted Diseases; Doxycycline
• Interventions: Other: Samples

• Registration Number: NCT06007534
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Post-exposure prophylaxis (PEP) using doxycycline 200 mg within 24 hours of unprotected sexual intercourse to prevent sexually transmitted infections has demonstrated a reduction in the incidence of chlamydial and syphilis infections and syphilis infection by 70% and 73% in men who have sex with men (MSM) undergoing pre-exposure prophylaxis prophylaxis (PrEP) for HIV. Other studies are underway or in development on doxycycline prophylaxis for bacterial STIs, which are particularly common in this population. Monitoring adherence to PEP is of great interest in guaranteeing the effectiveness of this strategy and to be able to assess the uptake of PEP among PrEP users. Among the many methods for assessing adherence, measuring drug concentrations is a more accurate measure of adherence than self-reporting.

The therapeutic monitoring of doxycycline and the assessment of adherence have been described using plasma and hair samples, allowing estimation of intake over the last 3-4 days and 4 months, respectively. Nevertheless, these biological matrices present several limitations for application in clinical practice: reflecting the duration of exposure should be more in line with the frequency of visits (2 months), and the collection of hair samples may be difficult due to refusal or short hair. On the other hand, interpretation of the hair assay is limited by the degradation of doxycycline in this matrix, which could lead to underestimation of drug intake. By Therefore, new biological matrices are needed for more accurate assessment of doxycycline adherence in post-exposure prevention monitoring.

The objective is to evaluate the pharmacokinetics of doxycycline in plasma, whole blood, dried blood spots (DBS), urine and hair after a single dose of doxycycline in men using oral doxycycline for post-exposure prophylaxis of sexually transmitted infections (syphilis or Chlamydia trachomatis) and having sex with men.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-23
• Study Start: 2023-10-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-04-25
• Study Completion: 2025-04-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• Adult male patient
• Men who have Sex with Men (MSM) on PrEP or HIV-infected 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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adult male patient	Samples	Men having Sex with Men on PrEP (pre-Exposition Prophylaxy) regularly taking doxycycline for Sexually Transmitted Infection (STI) prevention or HIV-infected

Primary Outcome Measures

Name	Time	Method
Concentration of doxycycline in urine	At Day 90

Secondary Outcome Measures

Name	Time	Method
Concentration of doxycycline in plasma	90 days after doxycycline intake
Concentration of doxycycline in whole blood	90 days after doxycycline intake
Concentration of doxycycline in Dried Blood Spot (DBS)	90 days after doxycycline intake
Concentration of doxycycline in urine	90 days after doxycycline intake
Concentration of doxycycline in oropharyngeal secretions	90 days after doxycycline intake
Concentration of doxycycline in rectal secretions	90 days after doxycycline intake
Doxycycline concentration in hair	3 months after doxycycline intake
Number of biological matrix(es) associated with a quantifiable doxycycline dosage	Up to 90 days	Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study.
Cmax (maximum concentration) in plasma	Until day 90
Cmax (maximum concentration) in whole blood	Until day 90
Cmax (maximum concentration) in Dried Blood Spot (DBS)	Until day 90
Cmax (maximum concentration) in urine	Until day 90
Cmax (maximum concentration) in hair	Until day 90
Cmax (maximum concentration) in rectal secretions	Until day 90
AUC (area under the curve) in plasma	Until day 90
AUC (area under the curve) in whole blood	Until day 90
AUC (area under the curve) in Dried Blood Spot (DBS)	Until day 90
AUC (area under the curve) in urine	Until day 90
AUC (area under the curve) in hair	Until day 90
AUC (area under the curve) in rectal secretions	Until day 90
Elimination clearance in plasma	Until day 90
Elimination clearance in whole blood	Until day 90
Elimination clearance in Dried Blood Spot (DBS)	Until day 90
Elimination clearance in urine	Until day 90
Elimination clearance in hair	Until day 90
Elimination clearance in rectal secretions	Until day 90
Half-life in plasma	Until day 90
Half-life in whole blood	Until day 90
Half-life in Dried Blood Spot (DBS)	Until day 90
Half-life in urine	Until day 90
Half-life in hair	Until day 90
Half-life in rectal secretions	Until day 90
Mean residence time in plasma	Until day 90
Mean residence time in whole blood	Until day 90
Mean residence time in Dried Blood Spot (DBS)	Until day 90
Mean residence time in urine	Until day 90
Mean residence time in hair	Until day 90
Mean residence time in rectal secretions	Until day 90
Volume of distribution in plasma	Until day 90
Volume of distribution in whole blood	Until day 90
Volume of distribution in Dried Blood Spot (DBS)	Until day 90
Volume of distribution in urine	Until day 90
Volume of distribution in hair	Until day 90
Volume of distribution in rectal secretions	Until day 90

Trial Locations

Locations (2)

Hôpital Lariboisière AP-HP; 🇫🇷 Paris, France

Hôpital Saint Louis AP-HP; 🇫🇷 Paris, France