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Antiretroviral Combination

Immediate doxycycline 100mg PO daily for Syphilis (DuDHS Trial)

Phase 4
Waitlist Available
Led By Troy Grennan, MD
Research Sponsored by British Columbia Centre for Disease Control
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights

DuDHS Trial Summary

Men who have sex with men remain at high risk for HIV infection. Targeting prevention interventions to MSM at highest risk of seroconversion is an important goal of combination prevention interventions. Antecedent diagnosis of another sexually transmitted infection (STI), particularly syphilis, may serve as an entry point for biomedical prevention as these individuals are at highest risk for incident HIV. The use of the antiretroviral combination of tenofovir/emtricitabine has been shown to be associated with an overall 44% reduction in HIV acquisition in high-risk MSM when taken daily as PrEP. In those individuals with detectable drug levels, the benefit was as high as 90% risk reduction. In real-world evaluations of PrEP, high-risk sexual behaviour may continue as evidenced by high rates of intercurrent sexually transmitted infections. As such, biomedical interventions that may offer additional reduction in acquisition of common sexually transmitted infections should also be evaluated. Recently a small pilot study has demonstrated potential benefit from a similar strategy for syphilis prevention. In this study 30 MSM were randomized to receive either 100mg doxycycline once daily or contingency management strategies linked to remaining free of sexually transmitted diseases at progressive study visits. Overall, those receiving doxycycline were significantly less likely to be diagnosed with any STI during followup than those in the comparator arm. The investigators therefore propose to undertake a pilot study to evaluate the feasibility of using both tenofovir/emtricitabine and doxycycline (immediate or deferred use) for pre-exposure prophylaxis amongst HIV-negative MSM with recent history of syphilis infection in Vancouver, Canada.

Eligible Conditions
  • Syphilis
  • HIV/AIDS

DuDHS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants reporting > 95% adherence to both HIV and syphilis PrEP therapies
The proportion of individuals reporting grade 3 or 4 adverse events in the immediate vs. deferred arms.
Doxycycline
+2 more
Secondary outcome measures
To describe incidence of gonorrhea or chlamydia infection over the study period.
To evaluate changes in sexual activity reported by study participants over the study period.
To evaluate incidence of recurrent syphilis re-infection stratified by use immediate versus deferred doxycycline PrEP.
Other outcome measures
To assess the changes in the composition of the rectal microbiome
To assess the incidence of HIV in study participants
To assess the incidence of doxycycline resistance in those with documented T. pallidum infection.

DuDHS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate doxycycline 100mg PO dailyExperimental Treatment2 Interventions
Individuals will receive tenofovir/emtricitabine one tablet daily in an open-label fashion. Subjects are randomized to immediate (12 months duration) doxycycline 100mg PO daily.
Group II: Deferred doxycycline 100mg PO dailyActive Control2 Interventions
Individuals will receive daily tenofovir/emtricitabine one tablet daily and will begin doxycycline 100mg PO daily after 6 months for a total duration of 6 months

Find a Location

Who is running the clinical trial?

British Columbia Centre for Disease ControlLead Sponsor
10 Previous Clinical Trials
2,531 Total Patients Enrolled
1 Trials studying Syphilis
52 Patients Enrolled for Syphilis
Troy Grennan, MDPrincipal InvestigatorBC Centre for Disease Control
2 Previous Clinical Trials
612 Total Patients Enrolled
1 Trials studying Syphilis
52 Patients Enrolled for Syphilis

Frequently Asked Questions

~8 spots leftby Apr 2025