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Completed

NCT Number: NCT04860505

Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens

The study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (STI) Post-exposure Prophylaxis (PEP).

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Key information

Conditions

Sexually Transmitted Diseases Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hope Clinic

Atlanta, Georgia, 30322, United States

About this study

To determine tissue pharmacology of a single dose of doxycycline for STI PEP, investigators at Emory University will collaborate with the Centers for Disease Control and Prevention (CDC) to conduct a clinical trial of up to 20 men who have sex with men (MSM) and women aged 18-59, with measurement of anti-retroviral drug and doxycycline concentrations in the rectum and vaginal regions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV negative person, who was assigned male or female at birth, who reports sex with another man in the last year and is in good general health
  • Aged 18-59 years
  • Not currently taking PrEP and no plans to initiate during study
  • Not currently taking PEP
  • Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study
  • Willing to use condoms consistently for the duration of the study
  • Able to provide informed consent in English
  • No plans for relocation in the next 4 months
  • 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
  • Hepatitis B surface antigen (HBsAg) negative (screening lab test)
  • Creatinine clearance >60 ml/min

Exclusion criteria

  • Currently infected with hepatitis virus and/ or has liver disease
  • Current or chronic history of kidney disease or creatinine clearance (CrCl)<60 ml/min
  • Continued need for, or use during the 90 days prior to enrollment, of the following medications:
  • Systemic immunomodulatory agents
  • Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators)
  • Chemotherapy or radiation for treatment of malignancy
  • Experimental medications, vaccines, or biologicals
  • Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) during the study, outside of the study procedures
  • Intent to use doxycycline or other tetracycline-derived antibiotics during the course of 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
  • Not pregnant and no plans on getting pregnant throughout the duration of the study
  • Known allergic reaction to study drugs

Treatment and study plan

Doxycycline

Drug

Doxycycline (DOX [200 mg]) is an oral medication used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections.

Biktarvy

Drug

Biktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.

Primary outcomes

  1. Rectal Doxycycline Concentration

    Time frame: 24 hours after a single dose

    Doxycycline concentration in tissue from a rectal biopsy was measured. Rectal biopsies were obtained from men. Women had the option to provide a rectal tissue sample.

  2. Vaginal Doxycycline Concentration

    Time frame: 24 hours after a single dose

    Doxycycline concentration in tissue from a vaginal biopsy was measured.

  3. Plasma Doxycycline Concentration

    Time frame: 24 hours after a single dose

    Doxycycline concentration in plasma was measured.

Secondary outcomes

  1. Rectal Bictegravir Concentration

    Time frame: 24 hours after a single dose

    Bectegravir concentration in tissue from a rectal biopsy was measured.

  2. Vaginal Bictegravir Concentration

    Time frame: 24 hours after a single dose

    Bictegravir concentration in tissue from a vaginal biopsy was measured.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2021
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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