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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 : Unknown
Verified August 2016 by Jonathan Troy Grennan, British Columbia Centre for Disease Control.
Recruitment status was:  Not yet recruiting
First Posted : July 26, 2016
Last Update Posted : August 8, 2016
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)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Tenofovir/Emtricitabine With Immediate or Deferred Daily Doxycycline 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).
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


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. To assess adherence to long-term HIV PrEP use. [ Time Frame: 12 months ]
    Proportion of individuals completing 12 months of tenofovir/emtricitabine

  2. To assess feasibility of using daily doxycycline for syphilis PrEP: [ Time Frame: 12 months ]
    1. Proportion of individuals successfully completing six and 12 month prophylaxis period.
    2. Adherence to doxycycline over the assigned study period.

  3. To evaluate the tolerability of daily doxycycline. [ Time Frame: 12 months ]
    To assess self-reported side effects on daily doxycycline, and side-effect related discontinuations


Secondary Outcome Measures :
  1. To evaluate changes in sexual activity reported by study participants over the study period. [ Time Frame: 12 months ]
  2. To evaluate syphilis re-infection rates over a 12 month period stratified by use of doxycycline for PrEP. [ Time Frame: 12 months ]
  3. To describe frequency of other STI's diagnosed in study participants over the study period. [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Change in tetracycline resistance in S.aureus nasal isolates [ Time Frame: 12 months ]
    To assess carriage rate of nasal S.aureus at beginning and end of the study period and to determine proportion of isolates with tetracycline resistance



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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:

  • Self-reported MSM status.
  • HIV negative based on HIV Nucleic Acid Amplification (NAT) testing.
  • Recent diagnosis of syphilis within preceding 36 months (defined on the basis of positive serum rapid plasma reagin (RPR) test, or positive darkfield microscopy result or T.pallidum direct fluorescent antibody test from a primary lesion).
  • Able to provide informed consent.

Exclusion Criteria:

  • HIV-positive individuals.
  • Recent (within 30 days) use of HIV post-exposure prophylaxis (any regimen).
  • Recent (within 30 days) use of HIV pre-exposure prophylaxis with tenofovir-emtricitabine or PrEP study drug.
  • Glomerular filtration rate < 60 mL/min.
  • Chronic active Hepatitis B infection.
  • History of intolerance/allergy or adverse reaction to any component of tenofovir/emtricitabine.
  • 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


Contacts
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Contact: Troy Grennan, MD 604 707 5606 troy.grennan@bccdc.ca
Contact: Mark W Hull, MD 604 806 8640 mhull@cfenet.ubc.ca

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: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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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Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Anti-HIV Agents
Syphilis
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Infection
Tenofovir
Emtricitabine
Doxycycline
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents