Doxycycline post-exposure prophylaxis: Weekly versus event-driven Intake for STI prevention among MSM and TGW taking PrEP

2025-524823-34-00 Protocol Doxy-WISE Therapeutic confirmatory (Phase III) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol Doxy-WISE

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruitment pending
Participants planned 556
Countries 1
Sites 1

Sexually Transmitted Infections

Assess if Weekly-DoxyPEP is non-inferior to Event-Driven-DoxyPEP in terms of the incidence rate of Neisseria gonorrhoeae (NG)/ Chlamydia trachomatis (CT) and Treponema pallidum (TP) infections among MSM and TGW taking HIV-PrEP in Belgium

Key facts

Sponsor
Institute Of Tropical Medicine
Participant type
Healthy volunteers
Age range
18-64 years, 65+ years
Gender
Male
Therapeutic area
Diseases [C] - Bacterial Infections and Mycoses [C01]
Decision date (initial)
2026-03-06
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
Fonds voor Wetenschappelijk Onderzoek

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis

Assess if Weekly-DoxyPEP is non-inferior to Event-Driven-DoxyPEP in terms of the incidence rate of Neisseria gonorrhoeae (NG)/ Chlamydia trachomatis (CT) and Treponema pallidum (TP) infections among MSM and TGW taking HIV-PrEP in Belgium

Secondary objectives 11

  1. Assess if there is a difference in antimicrobial consumption (tetracycline, macrolide, cephalosporin, penicillin) between arms
  2. Assess if there is a difference in antimicrobial susceptibility of commensal Neisseria spp., oral streptococci and E. coli between arms
  3. Assess if W-DoxyPEP is non-inferior to ED-DoxyPEP in terms of the incidence of symptomatic NG infections between arms
  4. Assess if W-DoxyPEP is non-inferior to ED-DoxyPEP in terms of the incidence of symptomatic CT infections between arms
  5. Assess is W-DoxyPEP is non-inferior to ED-DoxyPEP in terms of the incidence of symptomatic TP infections between arms
  6. Assess is W-DoxyPEP is non-inferior to ED-DoxyPEP in terms of incidence of all NG infections between arms
  7. Assess is W-DoxyPEP is non-inferior to ED-DoxyPEP in terms of the incidence of all CT infections between arms
  8. Assess is W-DoxyPEP is non-inferior to ED-DoxyPEP in terms of the incidence of TP infections between arms
  9. Assess if there is a difference in tetracycline resistance among NG isolates between arms
  10. Assess PrEP users’ experiences and perceptions in using doxyPEP
  11. Assess cost and potential cost-effectiveness of implementing W-DoxyPEP vs ED-DoxyPEP

Conditions and MedDRA coding

Sexually Transmitted Infections

VersionLevelCodeTermSystem organ class
21.1 LLT 10068720 Sexually transmitted infection 10021881

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Able and willing to provide informed consent in Dutch or English and adhere to the study procedures
  2. Aged 18 years or older
  3. Assigned male sex at birth
  4. Identifying as gay, bisexual or other men who have sex with men or transgender women
  5. Enrolled in PrEP care
  6. Being HIV negative
  7. Reporting having had condomless anal sex with at least one non-steady partner in the preceding year

Exclusion criteria 3

  1. Hypersensitivity to doxycycline or any substance used in the IMP
  2. Concomitant use of medication interacting with doxycycline
  3. Any contra-indication to the use of doxycycline, as mentioned in the summary of product characteristics

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Incidence rate ratio of NG, CT, and TP infections in the W-DoxyPEP vs ED-DoxyPEP arms

Secondary endpoints 11

  1. Rate ratio of tetracyclines, macrolides, cephalosporins, and penicillins in the W-DoxyPEP vs ED-DoxyPEP arms
  2. MIC distribution (doxycycline/cefixime/ciprofloxacin) of commensal Neisseria spp., oral streptococci and E. coli in the W-DoxyPEP vs ED-DoxyPEP arms
  3. Incidence rate ratio of symptomatic NG infections in the W-DoxyPEP vs ED-DoxyPEP arms
  4. Incidence rate ratio of symptomatic CT infections in the W-DoxyPEP vs ED-DoxyPEP arms
  5. Incidence rate ratio of symptomatic TP infections in the W-DoxyPEP vs ED-DoxyPEP arms
  6. Incidence rate ratio of all NG infections in the W-DoxyPEP vs ED-DoxyPEP arms
  7. Incidence rate ratio of all CT infections in the W-DoxyPEP vs ED-DoxyPEP arms
  8. Incidence rate ratio of all TP infections in the W-DoxyPEP vs ED-DoxyPEP arms
  9. Tetracycline MIC distribution of NG isolates in the W-DoxyPEP vs ED-DoxyPEP arms
  10. participants' perception/experience, preference, and acceptability in using doxyPEP
  11. Cost of integrating W-DoxyPEP vs ED-DoxyPEP in routine HIV-PrEP follow-up, if the strategy is proved to be effective, incremental cost per STI avoided/Quality of life Adjusted Life Years (QALY) gained

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Doxycycline Sandoz 100 mg tabletten

PRD753045 · Product

Active substance
Doxycycline
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
200 mg milligram(s)
Max total dose
41600 mg milligram(s)
Max treatment duration
52 Week(s)
Authorisation status
Authorised
ATC code
J01AA02 — DOXYCYCLINE
Marketing authorisation
BE209824
MA holder
SANDOZ N.V.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Doxycycline EG 200 mg Tabletten

PRD12236869 · Product

Active substance
Doxycycline
Substance synonyms
ANHYDROUS DOXYCYCLINE, DOXYCYCLINE ANHYDROUS
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
200 mg milligram(s)
Max total dose
41600 mg milligram(s)
Max treatment duration
52 Week(s)
Authorisation status
Authorised
ATC code
J01AA02 — DOXYCYCLINE
Marketing authorisation
BE178026
MA holder
EUROGENERICS N.V./S.A.
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institute Of Tropical Medicine

10 Total trials 3 Recruiting 4 Ended
Academic / Non-commercial
Sponsor organisation
Institute Of Tropical Medicine
Address
Nationalestraat 155
City
Antwerp
Postcode
2000
Country
Belgium

Scientific contact point

Organisation
Institute Of Tropical Medicine
Contact name
Chris Kenyon

Public contact point

Organisation
Institute Of Tropical Medicine
Contact name
Chris Kenyon

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Authorised, recruitment pending 556 1
Rest of world — 0 —

Investigational sites

Belgium

1 site · Authorised, recruitment pending
Institute Of Tropical Medicine
Department of Clinical Sciences, Nationalestraat 155, 2000, Antwerp

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2025-524823-34 3.0
Protocol (for publication) D4_Patient facing materials _ Acceptability Questionnaire_en 1.0
Protocol (for publication) D4_Patient facing materials _ Acceptability Questionnaire_nl 1
Protocol (for publication) D4_Patient facing materials _ EQ-5D-5L_en 1
Protocol (for publication) D4_Patient facing materials _EQ-5D-5L_nl 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements 1
Recruitment arrangements (for publication) K2_Recruitment Material flyer en 1
Recruitment arrangements (for publication) K2_Recruitment Material flyer nl 1
Recruitment arrangements (for publication) K2_Recruitment Material poster en 1
Recruitment arrangements (for publication) K2_Recruitment Material poster nl 1
Subject information and informed consent form (for publication) _Sponsor Statement Template ICF 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF main_en 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF main_nl 3.0
Summary of Product Characteristics (SmPC) (for publication) G_SmPC Doxycycline 100mg 1
Summary of Product Characteristics (SmPC) (for publication) G_SmPC Doxycycline_200mg 1
Synopsis of the protocol (for publication) D1_Protocol synopsis de 2025-524823-34 2.0
Synopsis of the protocol (for publication) D1_Protocol synopsis fr 2025-524823-34 2.0
Synopsis of the protocol (for publication) D1_Protocol synopsis nl 2025-524823-34 2.0

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-12-15 Belgium Acceptable
2026-03-05
 2026-03-06
2 NON SUBSTANTIAL MODIFICATION NSM-1 2026-03-10 Belgium Acceptable
2026-03-05
 2026-03-10

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