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

NCT06007534 | Recruiting

• 1 other identifier: APHP221156
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-exposure Prophylaxis; Sexually Transmitted Diseases; Doxycycline

Outcome Measures

Primary Outcomes (1)

• Concentration of doxycycline in urine

  At Day 90

Secondary Outcomes (97)

• Concentration of doxycycline in plasma

  Before the single intake of doxycycline

• Concentration of doxycycline in plasma

  2 hours after doxycycline intake

• Concentration of doxycycline in plasma

  24 hours after doxycycline intake

• Concentration of doxycycline in plasma

  48 hours after doxycycline intake

• Concentration of doxycycline in plasma

  7 days after doxycycline intake

Study Arms (1)

Adult male patient

OTHER

Men having Sex with Men on PrEP (pre-Exposition Prophylaxy) regularly taking doxycycline for Sexually Transmitted Infection (STI) prevention or HIV-infected

Other: Samples

Interventions

Samples OTHER

Blood samples, urine samples and oropharyngeal swabs before taking 200mg of doxycycline and then 2h, 24h, 48h, 7 days, 14 days, 60 days and 90 days after the single dose of doxycycline Hair samples: at the time of doxycycline administration, 1 month and 3 months after the single dose of doxycycline

Adult male patient

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Person affiliated or benefiting from a social security system (article L1121-11 of the Public Health Code)

You may not qualify if:

• 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
• Persons under guardianship, conservatorship, or deprived of liberty by judicial or administrative decision.
• Patients on State Medical Aid

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Lariboisière AP-HP

Paris, France

RECRUITING

Hôpital Saint Louis AP-HP

Paris, France

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Sampling Studies

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Lauriane GOLDWIRT, Dr

CONTACT

+33142494325; lauriane.goldwirt@aphp.fr

Jérôme Lambert, Dr

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: August 23, 2023
• Study Start: October 25, 2023
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

FR (2)