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NCT04860505

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

Completed Phase 4 Results posted Last updated 23 May 2023
What this trial tests

Phase 4 trial testing Doxycycline in Sexually Transmitted Diseases in 20 participants. Completed in 9 May 2022.

Timeline
20 May 2021
Primary endpoint
9 May 2022
9 May 2022

Quick facts

Lead sponsorEmory University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment20
Start date20 May 2021
Primary completion9 May 2022
Estimated completion9 May 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Emory University

Who can join

Adults 18 to 59, any sex, with Sexually Transmitted Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rectal Doxycycline Concentration Primary · 24 hours after a single dose

Doxycycline concentration in tissue from a rectal biopsy was measured. Rectal biopsies were obtained from men. Women had the option to provide a rectal tissue sample.

GroupValue95% CI
Doxycycline and Biktarvy0.6540.305 – 1.237
Vaginal Doxycycline Concentration Primary · 24 hours after a single dose

Doxycycline concentration in tissue from a vaginal biopsy was measured.

GroupValue95% CI
Doxycycline and Biktarvy0.3670.203 – 1.445
Plasma Doxycycline Concentration Primary · 24 hours after a single dose

Doxycycline concentration in plasma was measured.

GroupValue95% CI
Doxycycline and Biktarvy487305 – 824
Rectal Bictegravir Concentration Secondary · 24 hours after a single dose

Bectegravir concentration in tissue from a rectal biopsy was measured.

GroupValue95% CI
Doxycycline and Biktarvy0.085NA – 0.391
Vaginal Bictegravir Concentration Secondary · 24 hours after a single dose

Bictegravir concentration in tissue from a vaginal biopsy was measured.

GroupValue95% CI
Doxycycline and Biktarvy0.207NA – 1.038

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pharmacokinetics of single dose doxycycline in the rectum, vagina, and urethra: implications for prevention of bacterial sexually transmitted infections.
    Haaland RE, Fountain J, Edwards TE, Dinh C, et al · · 2024 · cited 30× · PMID 38428259 · DOI 10.1016/j.ebiom.2024.105037
  2. Chelating anticoagulants reduce plasma doxycycline measurements: implications for doxy PEP monitoring.
    Daly MB, Spandau M, Edwards TE, Dinh C, et al · · 2026 · PMID 41701614 · DOI 10.1080/17512433.2026.2632931

Verify or expand the search:

Other trials of Doxycycline

Trials testing the same drug.

Other recruiting trials for Sexually Transmitted Diseases

Currently open trials in the same condition.

Other Emory University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04860505.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing