Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men

NCT03980223 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: DoxyPEPR01AI143439
• Study Type: interventional
• Target: 641
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including gonorrhea, chlamydia and syphilis. The study will also look at the safety of doxycycline PEP and the impact that PEP may have on the bacteria that cause STIs as well as on bacteria that normally live on the body. While doxycycline is approved by the Food and Drug Administration (FDA), taking doxycycline immediately after sexual contact to prevent infection is investigational and is not approved by the FDA for this use. Participants will take part in the study for 1 year.

Conditions

Gonorrhea; Chlamydia; Syphilis

Keywords

HIV; Post-Exposure Prophylaxis; Men who have sex with men (MSM); Doxycycline; HIV Pre-Exposure Prophylaxis; Sexually transmitted infection

Outcome Measures

Primary Outcomes (1)

• Number of Quarterly Visits In Which an STI Was Detected

  Number of quarterly visits with an STI event detected.

  1 year

Study Arms (2)

Doxy PEP

EXPERIMENTAL

Doxycycline 200mg in addition to standard of care STI testing and treatment

Drug: Doxycycline Hyclate Delayed-Release 200 mg

Control

NO INTERVENTION

The control arm will consist of standard of care STI testing and treatment

Interventions

Doxycycline Hyclate Delayed-Release 200 mg DRUG

200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP)

Doxy PEP

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give written informed consent
• Age ≥ 18 years
• Male sex at birth
• Previously HIV-diagnosed OR HIV-seronegative at the time of last test within the past month and a current prescription for PrEP (both daily or event-driven permitted) or plan to start PrEP within 30 days after the enrollment visit
• Condomless anal or oral sexual contact with ≥ 1 male sex-at-birth partners in the past 12 months
• Diagnosed with GC, CT or early syphilis (primary, secondary or early latent) in the past 12 months. Note: self report of STI is acceptable if documentation not available. If the participant reports an incident STI in the past year at the same clinic where the participant will be enrolled, this diagnosis should be confirmed by chart review prior to enrollment. If the diagnosis from this clinic cannot be confirmed, the participant should not be enrolled. If the STI was reported at a clinical site that is not the study site, and records cannot be obtained, self-report will suffice.
• Note: Syphilis diagnosis within the last year refers to primary syphilis, secondary syphilis, and documented early latent syphilis (\< 1 year since last syphilis diagnosis or negative test). Known late latent syphilis or latent syphilis of unknown duration would not qualify. Positive syphilis titers which represent serofast status and not active disease do not qualify as a syphilis diagnosis. Clinician judgement regarding qualifying syphilis diagnosis should be sought when the diagnosis of syphilis in the past year is not clear or if there is a question about serofast status vs. active infection.

You may not qualify if:

• Allergy to tetracycline class
• Current medications which may impact doxycycline metabolism or that are contraindicated with doxycycline, as per the prescribing information. These include systemic retinoids, barbiturates, carbamazepine, and phenytoin.
• Current use of warfarin, as intermittent doxycycling use can lead to an unpredictable impact on INR
• Anticipated use of doxycycline during the coming 12 months for non-STI prevention (e.g., acne treatment).

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Washington: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Mayne Pharma International Pty Ltd: collaborator
• San Francisco Department of Public Health: collaborator

Study Sites (3)

San Francisco City Clinic / San Francisco Department of Public Health

San Francisco, California, 94103, United States

Location

University of California, San Francisco / Zuckerberg San Francisco General Hospital/UCSF

San Francisco, California, 94110, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (13)

• Molina JM, Charreau I, Chidiac C, Pialoux G, Cua E, Delaugerre C, Capitant C, Rojas-Castro D, Fonsart J, Bercot B, Bebear C, Cotte L, Robineau O, Raffi F, Charbonneau P, Aslan A, Chas J, Niedbalski L, Spire B, Sagaon-Teyssier L, Carette D, Mestre SL, Dore V, Meyer L; ANRS IPERGAY Study Group. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial. Lancet Infect Dis. 2018 Mar;18(3):308-317. doi: 10.1016/S1473-3099(17)30725-9. Epub 2017 Dec 8.

  PMID: 29229440 BACKGROUND

• The Lancet Hiv. U=U taking off in 2017. Lancet HIV. 2017 Nov;4(11):e475. doi: 10.1016/S2352-3018(17)30183-2. No abstract available.

  PMID: 29096785 BACKGROUND

• Harrison WO, Hooper RR, Wiesner PJ, Campbell AF, Karney WW, Reynolds GH, Jones OG, Holmes KK. A trial of minocycline given after exposure to prevent gonorrhea. N Engl J Med. 1979 May 10;300(19):1074-8. doi: 10.1056/NEJM197905103001903.

  PMID: 107450 BACKGROUND

• Steen R, Chersich M, Gerbase A, Neilsen G, Wendland A, Ndowa F, Akl EA, Lo YR, de Vlas SJ. Periodic presumptive treatment of curable sexually transmitted infections among sex workers: a systematic review. AIDS. 2012 Feb 20;26(4):437-45. doi: 10.1097/QAD.0b013e32834ed991.

  PMID: 22095197 BACKGROUND

• Bolan RK, Beymer MR, Weiss RE, Flynn RP, Leibowitz AA, Klausner JD. Doxycycline prophylaxis to reduce incident syphilis among HIV-infected men who have sex with men who continue to engage in high-risk sex: a randomized, controlled pilot study. Sex Transm Dis. 2015 Feb;42(2):98-103. doi: 10.1097/OLQ.0000000000000216.

  PMID: 25585069 BACKGROUND

• Sloan B, Scheinfeld N. The use and safety of doxycycline hyclate and other second-generation tetracyclines. Expert Opin Drug Saf. 2008 Sep;7(5):571-7. doi: 10.1517/14740338.7.5.571.

  PMID: 18759709 BACKGROUND

• Turner RB, Smith CB, Martello JL, Slain D. Role of doxycycline in Clostridium difficile infection acquisition. Ann Pharmacother. 2014 Jun;48(6):772-6. doi: 10.1177/1060028014528792. Epub 2014 Mar 28.

  PMID: 24682682 BACKGROUND

• Nadelman RB, Nowakowski J, Fish D, Falco RC, Freeman K, McKenna D, Welch P, Marcus R, Aguero-Rosenfeld ME, Dennis DT, Wormser GP; Tick Bite Study Group. Prophylaxis with single-dose doxycycline for the prevention of Lyme disease after an Ixodes scapularis tick bite. N Engl J Med. 2001 Jul 12;345(2):79-84. doi: 10.1056/NEJM200107123450201.

  PMID: 11450675 BACKGROUND

• Angelakis E, Armstrong N, Nappez C, Richez M, Chabriere E, Raoult D. Doxycycline assay hair samples for testing long-term compliance treatment. J Infect. 2015 Nov;71(5):511-7. doi: 10.1016/j.jinf.2015.08.003. Epub 2015 Aug 20.

  PMID: 26299894 BACKGROUND

• Luetkemeyer AF, Donnell D, Cohen SE, Dombrowski JC, Grabow C, Haser G, Brown C, Cannon C, Malinski C, Perkins R, Nasser M, Lopez C, Suchland RJ, Vittinghoff E, Buchbinder SP, Scott H, Charlebois ED, Havlir DV, Soge OO, Celum C. Doxycycline to prevent bacterial sexually transmitted infections in the USA: final results from the DoxyPEP multicentre, open-label, randomised controlled trial and open-label extension. Lancet Infect Dis. 2025 Aug;25(8):873-883. doi: 10.1016/S1473-3099(25)00085-4. Epub 2025 Mar 24.

  PMID: 40147465 DERIVED

• Chu VT, Glascock A, Donnell D, Grabow C, Brown CE, Ward R, Love C, Kalantar KL, Cohen SE, Cannon C, Woodworth MH, Kelley CF, Celum C, Luetkemeyer AF, Langelier CR. Impact of doxycycline post-exposure prophylaxis for sexually transmitted infections on the gut microbiome and antimicrobial resistome. Nat Med. 2025 Jan;31(1):207-217. doi: 10.1038/s41591-024-03274-2. Epub 2024 Oct 3.

  PMID: 39363100 DERIVED

• Fredericksen RJ, Perkins R, Brown CE, Cannon C, Lopez C, Cohee A, Dombrowski JC, Cohen S, Malinski C, Powell M, Luetkemeyer AF, Celum C, Christopoulos K. Doxycycline as Postsexual Exposure Prophylaxis: Use, Acceptability, and Associated Sexual Health Behaviors Among a Multi-Site Sample of Clinical Trial Participants. AIDS Patient Care STDS. 2024 Apr;38(4):155-167. doi: 10.1089/apc.2023.0289.

  PMID: 38656217 DERIVED

• Luetkemeyer AF, Donnell D, Dombrowski JC, Cohen S, Grabow C, Brown CE, Malinski C, Perkins R, Nasser M, Lopez C, Vittinghoff E, Buchbinder SP, Scott H, Charlebois ED, Havlir DV, Soge OO, Celum C; DoxyPEP Study Team. Postexposure Doxycycline to Prevent Bacterial Sexually Transmitted Infections. N Engl J Med. 2023 Apr 6;388(14):1296-1306. doi: 10.1056/NEJMoa2211934.

  PMID: 37018493 DERIVED

MeSH Terms

Conditions

Gonorrhea; Chlamydia Infections; Syphilis; Homosexuality; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Chlamydiaceae Infections; Treponemal Infections; Spirochaetales Infections; Sexuality; Sexual Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anne Luetkemeyer
• Organization: University of California, San Francisco

annie.luetkemeyer@ucsf.edu

415-502-5753

Study Officials

• Anne Luetkemeyer, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label randomized clinical trial

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: November 26, 2019
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: July 12, 2024
• Results First Posted: July 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)