Doxy-Post-exposure Prophylaxis
The goal of this project is to collect data regarding the ability of various oral doses of doxycycline to penetrate mucosal tissues in men and women to inform the combination of doxycycline with antiretrovirals (ARVs) for the development of single-dose event-driven multipurpose prevention strategies to protect against HIV and sexually transmitted infections (STIs). This study is of importance in the field of research because it allows the exploration of new dosing strategies that would permit a single event-driven oral dose of medications that could provide protection from HIV as well as other STIs. The study population that this study seeks to enroll are healthy people assigned male or female sex at birth and not using gender-affirming hormone therapy and are willing to undergo study procedures. Recruitment: Both face-to-face and online engagements will be conducted to recruit study participants. Face-to-face locations include bars and nightclubs, community organizations serving study populations, sports events, and community venues, and online engagements include dating sites, social networks, and craigslist, amongst other social medial platforms.
Conditions:
🦠 Sexually Transmitted Diseases
🗓️ Study Start (Actual) 31 May 2023
🗓️ Primary Completion (Estimated) September 2024
✅ Study Completion (Estimated) September 2024
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Aged 18-59 years
    • * Assigned male sex or female sex at birth
    • * In good general health
    • * Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study
    • * For HIV-positive people, on stable antiretroviral therapy with an undetectable viral load and CD4 count\> 300ul/ml
    • * Willing to use condoms consistently for the duration of the study
    • * Able to provide informed consent
    • * No plans for relocation in the next 4 months
    • * Not pregnant and does not plan on getting pregnant for the duration of the study
    • * Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure
    • * Willing to use study products as directed

    Exclusion Criteria:

    • * Current or chronic history of liver disease
    • * Continued need for, or use during the 90 days before enrollment, of the following medications:
    • 1. Systemic immunomodulatory agents
    • 2. Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators)
    • 3. Chemotherapy or radiation for treatment of malignancy
    • 4. Experimental medications, vaccines, or biologicals
    • * Intent to use doxycycline or other tetracycline-derived antibiotics during the study, outside of the study procedures
    • * Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements
    • * Known allergic reaction to study drugs.
    • * Significant laboratory abnormalities at baseline visit for rectal biopsies, including but not limited to:
    • 1. Hgb ≤ 10 g/dL
    • 2. PTT \> 1.5x ULN or INR \> 1.5x ULN
    • 3. Platelet count \<100,000
Ages Eligible for Study: 18 Years to 59 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 May 2023
  • First Submitted that Met QC Criteria 2 May 2023
  • First Posted 10 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 June 2024
  • Last Update Posted 18 June 2024
  • Last Verified June 2024