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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06007534
Other study ID # APHP221156
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 25, 2023
Est. completion date April 25, 2025

Study information

Verified date April 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Lauriane GOLDWIRT, Dr
Phone +33142494325
Email lauriane.goldwirt@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date April 25, 2025
Est. primary completion date April 25, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 100 Years
Eligibility 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) 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

Study Design


Intervention

Other:
Samples
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

Locations

Country Name City State
France Hôpital Lariboisière AP-HP Paris
France Hôpital Saint Louis AP-HP Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of doxycycline in urine At Day 90
Secondary Concentration of doxycycline in plasma Before the single intake of doxycycline
Secondary Concentration of doxycycline in plasma 2 hours after doxycycline intake
Secondary Concentration of doxycycline in plasma 24 hours after doxycycline intake
Secondary Concentration of doxycycline in plasma 48 hours after doxycycline intake
Secondary Concentration of doxycycline in plasma 7 days after doxycycline intake
Secondary Concentration of doxycycline in plasma 14 days after doxycycline intake
Secondary Concentration of doxycycline in plasma 30 days after doxycycline intake
Secondary Concentration of doxycycline in plasma 60 days after doxycycline intake
Secondary Concentration of doxycycline in plasma 90 days after doxycycline intake
Secondary Concentration of doxycycline in whole blood Before the single intake of doxycycline
Secondary Concentration of doxycycline in whole blood 2 hours after doxycycline intake
Secondary Concentration of doxycycline in whole blood 24 hours after doxycycline intake
Secondary Concentration of doxycycline in whole blood 48 hours after doxycycline intake
Secondary Concentration of doxycycline in whole blood 7 days after doxycycline intake
Secondary Concentration of doxycycline in whole blood 14 days after doxycycline intake
Secondary Concentration of doxycycline in whole blood 30 days after doxycycline intake
Secondary Concentration of doxycycline in whole blood 60 days after doxycycline intake
Secondary Concentration of doxycycline in whole blood 90 days after doxycycline intake
Secondary Concentration of doxycycline in Dried Blood Spot (DBS) Before the single intake of doxycycline
Secondary Concentration of doxycycline in Dried Blood Spot (DBS) 2 hours after doxycycline intake
Secondary Concentration of doxycycline in Dried Blood Spot (DBS) 24 hours after doxycycline intake
Secondary Concentration of doxycycline in Dried Blood Spot (DBS) 48 hours after doxycycline intake
Secondary Concentration of doxycycline in Dried Blood Spot (DBS) 7 days after doxycycline intake
Secondary Concentration of doxycycline in Dried Blood Spot (DBS) 14 days after doxycycline intake
Secondary Concentration of doxycycline in Dried Blood Spot (DBS) 30 days after doxycycline intake
Secondary Concentration of doxycycline in Dried Blood Spot (DBS) 60 days after doxycycline intake
Secondary Concentration of doxycycline in Dried Blood Spot (DBS) 90 days after doxycycline intake
Secondary Concentration of doxycycline in urine Before the single intake of doxycycline
Secondary Concentration of doxycycline in urine 2 hours after doxycycline intake
Secondary Concentration of doxycycline in urine 24 hours after doxycycline intake
Secondary Concentration of doxycycline in urine 48 hours after doxycycline intake
Secondary Concentration of doxycycline in urine 7 days after doxycycline intake
Secondary Concentration of doxycycline in urine 14 days after doxycycline intake
Secondary Concentration of doxycycline in urine 30 days after doxycycline intake
Secondary Concentration of doxycycline in urine 60 days after doxycycline intake
Secondary Concentration of doxycycline in oropharyngeal secretions Before the single intake of doxycycline
Secondary Concentration of doxycycline in oropharyngeal secretions 2 hours after doxycycline intake
Secondary Concentration of doxycycline in oropharyngeal secretions 24 hours after doxycycline intake
Secondary Concentration of doxycycline in oropharyngeal secretions 48 hours after doxycycline intake
Secondary Concentration of doxycycline in oropharyngeal secretions 7 days after doxycycline intake
Secondary Concentration of doxycycline in oropharyngeal secretions 14 days after doxycycline intake
Secondary Concentration of doxycycline in oropharyngeal secretions 30 days after doxycycline intake
Secondary Concentration of doxycycline in oropharyngeal secretions 60 days after doxycycline intake
Secondary Concentration of doxycycline in oropharyngeal secretions 90 days after doxycycline intake
Secondary Doxycycline concentration in hair Before the single intake of doxycycline
Secondary Doxycycline concentration in hair 1 month after doxycycline intake
Secondary Doxycycline concentration in hair 3 months after doxycycline intake
Secondary Number of biological matrix(es) associated with a quantifiable doxycycline dosage Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study. Up to 15 days
Secondary Number of biological matrix(es) associated with a quantifiable doxycycline dosage Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study. Up to 30 days
Secondary Number of biological matrix(es) associated with a quantifiable doxycycline dosage Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study. Up to 60 days
Secondary Number of biological matrix(es) associated with a quantifiable doxycycline dosage Determine the biological matrix(es) associated with a quantifiable doxycycline dosage in more than 90% of the samples collected during the study. Up to 90 days
Secondary Cmax (maximum concentration) in plasma Until day 90
Secondary Cmax (maximum concentration) in whole blood Until day 90
Secondary Cmax (maximum concentration) in Dried Blood Spot (DBS) Until day 90
Secondary Cmax (maximum concentration) in urine Until day 90
Secondary Cmax (maximum concentration) in hair Until day 90
Secondary AUC (area under the curve) in plasma Until day 90
Secondary AUC (area under the curve) in whole blood Until day 90
Secondary AUC (area under the curve) in Dried Blood Spot (DBS) Until day 90
Secondary AUC (area under the curve) in urine Until day 90
Secondary AUC (area under the curve) in hair Until day 90
Secondary Elimination clearance in plasma Until day 90
Secondary Elimination clearance in whole blood Until day 90
Secondary Elimination clearance in Dried Blood Spot (DBS) Until day 90
Secondary Elimination clearance in urine Until day 90
Secondary Elimination clearance in hair Until day 90
Secondary Half-life in plasma Until day 90
Secondary Half-life in whole blood Until day 90
Secondary Half-life in Dried Blood Spot (DBS) Until day 90
Secondary Half-life in urine Until day 90
Secondary Half-life in hair Until day 90
Secondary Mean residence time in plasma Until day 90
Secondary Mean residence time in whole blood Until day 90
Secondary Mean residence time in Dried Blood Spot (DBS) Until day 90
Secondary Mean residence time in urine Until day 90
Secondary Mean residence time in hair Until day 90
Secondary Volume of distribution in plasma Until day 90
Secondary Volume of distribution in whole blood Until day 90
Secondary Volume of distribution in Dried Blood Spot (DBS) Until day 90
Secondary Volume of distribution in urine Until day 90
Secondary Volume of distribution in hair Until day 90
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