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Trial record 86 of 214 for:    TETRACYCLINE

Oral Doxycycline for the Prevention of Syphilis in Men Who Have Sex With Men (DaDHS)

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ClinicalTrials.gov Identifier: NCT02864550
Recruitment Status : Not yet recruiting
First Posted : August 12, 2016
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Troy Grennan, British Columbia Centre for Disease Control

Brief Summary:
Syphilis is a sexually transmitted infection (STI) disproportionately affecting gay, bisexual and other men who have sex with men (gbMSM), with the potential for significant sequelae - particularly in those who are Human Immunodeficiency Virus (HIV)-positive. Rising rates of this STI have prompted a search for novel prevention solutions. A recent pilot study of daily doxycycline prophylaxis demonstrated promise as a novel STI prevention tool. This innovative approach to STI prevention has solid clinical precedent, both from the HIV pre-exposure prophylaxis (PrEP) literature, as well as doxycycline's use as prophylaxis for other infections. The overarching goal of this project is to determine whether the daily use of doxycycline is an efficacious and acceptable intervention for syphilis prevention in high-risk, HIV-positive gbMSM.

Condition or disease Intervention/treatment Phase
Syphilis Sexually Transmitted Infections Drug: Doxycycline Other: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Placebo-controlled Trial of Oral Doxycycline for the Prevention of Syphilis in HIV-positive Men Who Have Sex With Men (MSM)
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: Doxycycline arm
Participants in this intervention group will receive doxycycline 100mg orally daily, which is available as a 100mg capsule. This single daily dose was chosen to maximize adherence, given the common use of once-daily Human Immunodeficiency Virus (HIV) pre-exposure prophylaxis (PrEP), as well as its efficacy as once-daily prophylaxis against malaria and its utility as dosing as infrequent as once weekly for another spirochete infection, leptospirosis.
Drug: Doxycycline
doxycycline 100mg orally daily

Placebo Comparator: Placebo arm
Participants in this control group will receive a placebo capsule identical in appearance, taste, and size to the capsule provided to the intervention group.
Other: Placebo
placebo capsule identical in appearance, taste, and size to the capsule provided to the intervention group




Primary Outcome Measures :
  1. To assess the proportion of participants who are eligible and consent to participate amongst those approached. [ Time Frame: 15 months ]
    To determine the feasibility of daily syphilis PrEP

  2. To assess the proportion of participants reporting > 95% adherence to study drug, according to self-report and pill counts. [ Time Frame: 15 months ]
    To determine the feasibility of daily syphilis PrEP

  3. To assess the proportion of individuals with therapeutic doxycycline drug level (defined at ≥ 1000 ng/mL) at each study time point. [ Time Frame: 15 months ]
    To determine the feasibility of daily syphilis PrEP

  4. To assess the proportion of individuals reporting grade 3 or 4 adverse events in each study arm. [ Time Frame: 15 months ]
    To determine the feasibility of daily syphilis PrEP

  5. Proportion of individuals with adverse event-related study drug discontinuation in each study arm. [ Time Frame: 15 months ]
    To determine the feasibility of daily syphilis PrEP


Secondary Outcome Measures :
  1. To assess the proportion of individuals with evidence of tetracycline class resistance in common flora (Staphylococcus aureus, Streptococcus pyogene and Streptococcus pneumoniae) [ Time Frame: At 6 and 12 months ]
    To evaluate tetracycline class resistance in common flora (i.e. syphilis, gonorrhea, or chlamydia)

  2. To assess the changes in sexual risk behaviour will be calculated by comparing risk parameters (i.e. number partners, number of anal sexual encounters that were condomless) from pre-PrEP initiation to the study period. [ Time Frame: 15 months ]
    Change in sexual behaviour will also be compared between study arms.

  3. To assess the incidence of early syphilis infection [ Time Frame: 15 months ]
    To evaluate syphilis and other STI incidence over the study period.

  4. To assess the incidence of gonorrhea or chlamydia infection [ Time Frame: 15 months ]
    To evaluate syphilis and other STI incidence over the study period.


Other Outcome Measures:
  1. To assess changes in the bacterial populations found in the rectal microbiome. [ Time Frame: 15 months ]
    Exploratory outcome: to assess % changes of each bacterial genus in rectal microbiome



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

The inclusion criteria for this study are as follows:

  1. Males, ≥ 18 years of age at baseline;
  2. Self-reported MSM status;
  3. Self-report condomless anal sex with a man within the last 6 months;
  4. Laboratory documentation of HIV-1 infection;
  5. Prior diagnosis of early/infectious syphilis (i.e. primary, secondary or early latent) 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.

The exclusion criteria for this study are as follows:

  1. Known allergy or intolerance to doxycycline or tetracyclines;
  2. A known diagnosis of myasthenia gravis;
  3. Use of medications which could lower doxycycline levels, including barbiturates, phenytoin and carbamazepine;
  4. Individuals using isotretinoin;
  5. Any individual capable of getting pregnant.

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): NCT02864550


Contacts
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Contact: Troy Grennan, MD 604-707-5606 Troy.Grennan@bccdc.ca

Locations
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Canada, British Columbia
British Columbia Centre for Disease Control Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4R4
Contact: Troy Grennan, MD    604-707-5606    Troy.Grennan@bccdc.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:
Ontario Agency for Health Protection and Promotion (Public Health Ontario). Reportable Disease Trends in Ontario, 2013. Toronto, ON: Queen's Printer for Ontario; 2015.
Burchell AN, Allen V, Tan D, et al. Variations in syphilis testing and diagnosis among MSM in HIV care in Ontario according to sexual behaviour (abstract). Can J Infect Dis Med Microbiol. 2014;25(Supp A).[20. Hart G. Syphilis tests in diagnostic and therapeutic decision making. Ann Intern Med. 1986;104(3):368.

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Responsible Party: Jonathan Troy Grennan, Physician Lead, HIV/STI program, BCCDC, British Columbia Centre for Disease Control
ClinicalTrials.gov Identifier: NCT02864550     History of Changes
Other Study ID Numbers: BritishCCDC2
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019

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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:
Men who have sex with men
Human immunodeficiency virus
Doxycycline
Tetracycline
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Syphilis
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents