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

Sexually Transmitted Diseases Clinical Trial

Official title:
Caractérisation de la pharmacocinétique d'Une Dose Unique de 200 mg de Doxycycline en Prophylaxie Post-exposition (PEP) Des Infections Sexuellement Transmissibles Dans différents Compartiments Biologiques

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06007534
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact	Lauriane GOLDWIRT, Dr
Phone	+33142494325
Email	lauriane.goldwirt@aphp.fr
Status	Recruiting
Phase	N/A
Start date	October 25, 2023
Completion date	April 25, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02579135` - Reducing HIV Risk Among Adolescents: Evaluating Project HEART	N/A
Enrolling by invitation	`NCT06127277` - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care	N/A
Recruiting	`NCT05889689` - Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters	N/A
Completed	`NCT02516930` - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China	N/A
Completed	`NCT03063385` - Puerto Rico Cuidalos Parent-adolescent Program	N/A
Completed	`NCT02009046` - Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students	N/A
Completed	`NCT01411878` - Louisville Teen Pregnancy Prevention Project	N/A
Completed	`NCT01303575` - Internet-Based Sexual Health Education for Middle School Native American Youth	N/A
Completed	`NCT00167505` - All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students	N/A
Completed	`NCT00183456` - A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs	Phase 2
Completed	`NCT00336180` - Adolescent Drug and HIV Prevention in South Africa	Phase 2/Phase 3
Completed	`NCT00161382` - Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students	N/A
Completed	`NCT01084395` - Reducing HIV Risk Among Mexican Youth	N/A
Completed	`NCT00710060` - Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations	Phase 3
Completed	`NCT00640653` - Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents	N/A
Completed	`NCT00289939` - Reducing HIV & Domestic Violence Risk in Women Offenders	Phase 3
Completed	`NCT00137943` - Parents Matter!: Interventions to Promote Effective Parent-Child Communication	Phase 1
Completed	`NCT03408743` - Engineering an Online STI Prevention Program: CSE2	N/A
Completed	`NCT06104813` - Evaluation of Deaf Men's Knowledge About Sexual Health
Not yet recruiting	`NCT05910580` - Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.