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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
25
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
Hôpital Lariboisière AP-HP
Paris, France
RECRUITINGHôpital Saint Louis AP-HP
Paris, France
RECRUITINGConcentration of doxycycline in urine
Time frame: At Day 90
Concentration of doxycycline in plasma
Time frame: Before the single intake of doxycycline
Concentration of doxycycline in plasma
Time frame: 2 hours after doxycycline intake
Concentration of doxycycline in plasma
Time frame: 24 hours after doxycycline intake
Concentration of doxycycline in plasma
Time frame: 48 hours after doxycycline intake
Concentration of doxycycline in plasma
Time frame: 7 days after doxycycline intake
Concentration of doxycycline in plasma
Time frame: 14 days after doxycycline intake
Concentration of doxycycline in plasma
Time frame: 30 days after doxycycline intake
Concentration of doxycycline in plasma
Time frame: 60 days after doxycycline intake
Concentration of doxycycline in plasma
Time frame: 90 days after doxycycline intake
Concentration of doxycycline in whole blood
Time frame: Before the single intake of doxycycline
Concentration of doxycycline in whole blood
Time frame: 2 hours after doxycycline intake
Concentration of doxycycline in whole blood
Time frame: 24 hours after doxycycline intake
Concentration of doxycycline in whole blood
Time frame: 48 hours after doxycycline intake
Concentration of doxycycline in whole blood
Time frame: 7 days after doxycycline intake
Concentration of doxycycline in whole blood
Time frame: 14 days after doxycycline intake
Concentration of doxycycline in whole blood
Time frame: 30 days after doxycycline intake
Concentration of doxycycline in whole blood
Time frame: 60 days after doxycycline intake
Concentration of doxycycline in whole blood
Time frame: 90 days after doxycycline intake
Concentration of doxycycline in Dried Blood Spot (DBS)
Time frame: Before the single intake of doxycycline
Concentration of doxycycline in Dried Blood Spot (DBS)
Time frame: 2 hours after doxycycline intake
Concentration of doxycycline in Dried Blood Spot (DBS)
Time frame: 24 hours after doxycycline intake
Concentration of doxycycline in Dried Blood Spot (DBS)
Time frame: 48 hours after doxycycline intake
Concentration of doxycycline in Dried Blood Spot (DBS)
Time frame: 7 days after doxycycline intake
Concentration of doxycycline in Dried Blood Spot (DBS)
Time frame: 14 days after doxycycline intake
Concentration of doxycycline in Dried Blood Spot (DBS)
Time frame: 30 days after doxycycline intake
Concentration of doxycycline in Dried Blood Spot (DBS)
Time frame: 60 days after doxycycline intake
Concentration of doxycycline in Dried Blood Spot (DBS)
Time frame: 90 days after doxycycline intake
Concentration of doxycycline in urine
Time frame: Before the single intake of doxycycline
Concentration of doxycycline in urine
Time frame: 2 hours after doxycycline intake
Concentration of doxycycline in urine
Time frame: 24 hours after doxycycline intake
Concentration of doxycycline in urine
Time frame: 48 hours after doxycycline intake
Concentration of doxycycline in urine
Time frame: 7 days after doxycycline intake
Concentration of doxycycline in urine
Time frame: 14 days after doxycycline intake
Concentration of doxycycline in urine
Time frame: 30 days after doxycycline intake
Concentration of doxycycline in urine
Time frame: 60 days after doxycycline intake
Concentration of doxycycline in urine
Time frame: 90 days after doxycycline intake
Concentration of doxycycline in oropharyngeal secretions
Time frame: Before the single intake of doxycycline
Concentration of doxycycline in oropharyngeal secretions
Time frame: 2 hours after doxycycline intake
Concentration of doxycycline in oropharyngeal secretions
Time frame: 24 hours after doxycycline intake
Concentration of doxycycline in oropharyngeal secretions
Time frame: 48 hours after doxycycline intake
Concentration of doxycycline in oropharyngeal secretions
Time frame: 7 days after doxycycline intake
Concentration of doxycycline in oropharyngeal secretions
Time frame: 14 days after doxycycline intake
Concentration of doxycycline in oropharyngeal secretions
Time frame: 30 days after doxycycline intake
Concentration of doxycycline in oropharyngeal secretions
Time frame: 60 days after doxycycline intake
Concentration of doxycycline in oropharyngeal secretions
Time frame: 90 days after doxycycline intake
Concentration of doxycycline in rectal secretions
Time frame: Before the single intake of doxycycline
Concentration of doxycycline in rectal secretions
Time frame: 2 hours after doxycycline intake
Concentration of doxycycline in rectal secretions
Time frame: 24 hours after doxycycline intake
Concentration of doxycycline in rectal secretions
Time frame: 48 hours after doxycycline intake
Concentration of doxycycline in rectal secretions
Time frame: 7 days after doxycycline intake
Concentration of doxycycline in rectal secretions
Time frame: 14 days after doxycycline intake
Concentration of doxycycline in rectal secretions
Time frame: 30 days after doxycycline intake
Concentration of doxycycline in rectal secretions
Time frame: 60 days after doxycycline intake
Concentration of doxycycline in rectal secretions
Time frame: 90 days after doxycycline intake
Doxycycline concentration in hair
Time frame: Before the single intake of doxycycline
Doxycycline concentration in hair
Time frame: 1 month after doxycycline intake
Doxycycline concentration in hair
Time frame: 3 months after doxycycline intake
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.
Time frame: Up to 15 days
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.
Time frame: Up to 30 days
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.
Time frame: Up to 60 days
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.
Time frame: Up to 90 days
Cmax (maximum concentration) in plasma
Time frame: Until day 90
Cmax (maximum concentration) in whole blood
Time frame: Until day 90
Cmax (maximum concentration) in Dried Blood Spot (DBS)
Time frame: Until day 90
Cmax (maximum concentration) in urine
Time frame: Until day 90
Cmax (maximum concentration) in hair
Time frame: Until day 90
Cmax (maximum concentration) in rectal secretions
Time frame: Until day 90
AUC (area under the curve) in plasma
Time frame: Until day 90
AUC (area under the curve) in whole blood
Time frame: Until day 90
AUC (area under the curve) in Dried Blood Spot (DBS)
Time frame: Until day 90
AUC (area under the curve) in urine
Time frame: Until day 90
AUC (area under the curve) in hair
Time frame: Until day 90
AUC (area under the curve) in rectal secretions
Time frame: Until day 90
Elimination clearance in plasma
Time frame: Until day 90
Elimination clearance in whole blood
Time frame: Until day 90
Elimination clearance in Dried Blood Spot (DBS)
Time frame: Until day 90
Elimination clearance in urine
Time frame: Until day 90
Elimination clearance in hair
Time frame: Until day 90
Elimination clearance in rectal secretions
Time frame: Until day 90
Half-life in plasma
Time frame: Until day 90
Half-life in whole blood
Time frame: Until day 90
Half-life in Dried Blood Spot (DBS)
Time frame: Until day 90
Half-life in urine
Time frame: Until day 90
Half-life in hair
Time frame: Until day 90
Half-life in rectal secretions
Time frame: Until day 90
Mean residence time in plasma
Time frame: Until day 90
Mean residence time in whole blood
Time frame: Until day 90
Mean residence time in Dried Blood Spot (DBS)
Time frame: Until day 90
Mean residence time in urine
Time frame: Until day 90
Mean residence time in hair
Time frame: Until day 90
Mean residence time in rectal secretions
Time frame: Until day 90
Volume of distribution in plasma
Time frame: Until day 90
Volume of distribution in whole blood
Time frame: Until day 90
Volume of distribution in Dried Blood Spot (DBS)
Time frame: Until day 90
Volume of distribution in urine
Time frame: Until day 90
Volume of distribution in hair
Time frame: Until day 90
Volume of distribution in rectal secretions
Time frame: Until day 90
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