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Trial record 1 of 1 for:    tenofovir doxycycline syphilis
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Tenofovir/Emtricitabine With Doxycycline for Combination HIV and Syphilis Pre-exposure Prophylaxis in HIV-negative MSM (DuDHS)

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ClinicalTrials.gov Identifier: NCT02844634
Recruitment Status : Active, not recruiting
First Posted : July 26, 2016
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Troy Grennan, British Columbia Centre for Disease Control

Brief 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.


Condition or disease Intervention/treatment Phase
HIV Syphilis Drug: Doxycycline 100mg PO daily x 12 months Drug: Tenofovir/emtricitabine 200/300mg PO daily Drug: Doxycycline 100mg PO daily x 6 months Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Tenofovir/Emtricitabine With Immediate or Deferred Doxycycline 100mg PO Daily for Combination HIV and Syphilis Pre-exposure Prophylaxis in HIV-negative Men Who Have Sex With Men: a Pilot Study of Dual Daily HIV and Syphilis PrEP. (The DuDHS Trial).
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : May 28, 2020
Estimated Study Completion Date : June 30, 2020


Arm Intervention/treatment
Experimental: Immediate doxycycline 100mg PO daily

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.

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

Active Comparator: Deferred doxycycline 100mg PO daily
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
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)




Primary Outcome Measures :
  1. The proportion of participants who are eligible and consent to participate amongst those approached. [ Time Frame: 12 months ]
    To evaluate the feasibility of recruitment for a larger study

  2. Proportion of participants reporting > 95% adherence to both HIV and syphilis PrEP therapies [ Time Frame: 12 months ]
    To assess adherence of dual HIV and syphilis PrEP therapies

  3. The proportion of individuals with detectable doxycycline at each study time point. [ Time Frame: 12 months ]
    To assess adherence of syphilis PrEP therapy

  4. The proportion of individuals reporting grade 3 or 4 adverse events in the immediate vs. deferred arms. [ Time Frame: 12 months ]
    To assess the tolerability of dual HIV and syphilis PrEP therapies

  5. The proportion of individuals with evidence of tetracycyline class resistance in common flora [ Time Frame: 6 and 12 months ]
    To evaluate antimicrobial resistance over time


Secondary Outcome Measures :
  1. To evaluate changes in sexual activity reported by study participants over the study period. [ Time Frame: 12 months ]
    Evaluation of sexual activity over time

  2. To evaluate incidence of recurrent syphilis re-infection stratified by use immediate versus deferred doxycycline PrEP. [ Time Frame: 12 months ]
    Evaluation of syphilis incidence rates between the two study arms

  3. To describe incidence of gonorrhea or chlamydia infection over the study period. [ Time Frame: 12 months ]
    Assessment of the frequency of other STIs over time


Other Outcome Measures:
  1. To assess the incidence of HIV in study participants [ Time Frame: 12 months ]
    Exploratory outcome to access incidence rates for HIV infection

  2. To assess the incidence of doxycycline resistance in those with documented T. pallidum infection. [ Time Frame: 12 months ]
    Exploratory outcome to assess incidence rates for doxycycline resistance

  3. To assess the changes in the composition of the rectal microbiome [ Time Frame: 6 and 12 months ]
    Exploratory outcome to determine percentage changes in the bacterial genius of the rectal microbiome



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 19 years of age.
  2. Self-reported MSM status.
  3. Self-report condomless anal sex with a man within the last 6 months.
  4. HIV negative based on HIV nucleic acid amplification testing (NAT).
  5. Prior diagnosis of syphilis within preceding 36 months (defined on the basis of a new positive serum rapid plasma reagin (RPR) test, or ≥2-dilution rise in titre if previous syphilis, or positive darkfield microscopy result or T. pallidum direct fluorescent antibody test or PCR from a primary lesion).
  6. Able to provide informed consent.

Exclusion Criteria:

  1. HIV-positive individuals.
  2. Recent (within last 30 days) use of HIV post-exposure prophylaxis (PEP).
  3. Impaired renal function defined as glomerular filtration rate < 60 mL/min.
  4. Chronic active Hepatitis B infection.
  5. History of myasthenia gravis.
  6. History of tetracycline/doxycycline allergy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844634


Locations
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Canada, British Columbia
BC Centre for Disease Control
Vancouver, British Columbia, Canada, V5Z4R4
Sponsors and Collaborators
British Columbia Centre for Disease Control
Investigators
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Principal Investigator: Troy Grennan, MD BC Centre for Disease Control

Publications of Results:
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Responsible Party: Jonathan Troy Grennan, Physician Lead HIV/STI Program, British Columbia Centre for Disease Control
ClinicalTrials.gov Identifier: NCT02844634     History of Changes
Other Study ID Numbers: BritishCCDC
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jonathan Troy Grennan, British Columbia Centre for Disease Control:
pre-exposure prophylaxis
men who have sex with men
HIV prevention
sexually transmitted infection
syphilis

Additional relevant MeSH terms:
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Syphilis
Tenofovir
Doxycycline
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents