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

NCT04860505 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-23

Study results available
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Summary

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

Conditions

  • Sexually Transmitted Diseases

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Colleen Kelley, MD, MPH · Emory University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2022-05-09
Completion
2022-05-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04860505 on ClinicalTrials.gov