NCT04860505

Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (STI) Post-exposure Prophylaxis (PEP).

Detailed description

To determine tissue pharmacology of a single dose of doxycycline for STI PEP, investigators at Emory University will collaborate with the Centers for Disease Control and Prevention (CDC) to conduct a clinical trial of up to 20 men who have sex with men (MSM) and women aged 18-59, with measurement of anti-retroviral drug and doxycycline concentrations in the rectum and vaginal regions.

Conditions

• Sexually Transmitted Diseases

Interventions

Type	Name	Description
DRUG	Doxycycline	Doxycycline (DOX \[200 mg\]) is an oral medication used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections.
DRUG	Biktarvy	Biktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.

Timeline

• Start date: 2021-05-20
• Primary completion: 2022-05-09
• Completion: 2022-05-09
• First posted: 2021-04-27
• Last updated: 2023-05-23
• Results posted: 2023-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study