Actively Recruiting
Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-09-19
25
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male patient
- Men who have sex with men (MSM) on PrEP or HIV-infected
- Have not taken doxycycline for at least 3 months
- No symptoms of bacterial STI infection (chlamydia, gonorrhea, Mycoplasma genitalium, or syphilis)
- History of bacterial STI infection within the past 12 months
- Had risky intercourse within 24 to 72 hours with a doxycycline 200 mg prescription as part of usual care
- Provided free, informed, written consent before any study exams
- Affiliated with or benefiting from a social security system
You will not qualify if you...
- Taking systemic treatment with retinoids (e.g., Acnetrait®, Procuta®, Curacné®, Contracné®)
- Using enzyme-inducing anticonvulsants (carbamazepine, phenobarbital, phenytoin, etc.)
- Known allergy to tetracycline antibiotics
- Known allergy to any component of doxycycline tablets
- Documented esophageal injury
- Currently on doxycycline treatment at inclusion
- Participating in another research study with an ongoing exclusion period
- Under guardianship, conservatorship, or deprived of liberty by judicial or administrative decision
- Receiving State Medical Aid
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Trial Site Locations
Total: 2 locations
1
Hôpital Lariboisière AP-HP
Paris, France
Actively Recruiting
2
Hôpital Saint Louis AP-HP
Paris, France
Actively Recruiting
Research Team
L
Lauriane GOLDWIRT, Dr
CONTACT
J
Jérôme Lambert, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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