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Tenofovir/Emtricitabine With Doxycycline for Combination HIV and Syphilis Pre-exposure Prophylaxis in HIV-negative MSM

NCT02844634 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-08-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Doxycycline 100mg PO daily x 12 months

Immediate use of daily doxycycline (12 months duration, to start immediately)

DRUG

Tenofovir/emtricitabine 200/300mg PO daily

Daily use of tenofovir/emtricitabine

DRUG

Doxycycline 100mg PO daily x 6 months

Deferred use of doxycycline (6 months duration, to start 6 months post-randomization)

Sponsors & Collaborators

  • British Columbia Centre for Disease Control

    lead OTHER_GOV

Principal Investigators

  • Troy Grennan, MD · BC Centre for Disease Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-15
Primary Completion
2020-05-28
Completion
2022-09-07

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02844634 on ClinicalTrials.gov