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).

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases
• Intervention / Treatment: Drug: Doxycycline; Drug: Biktarvy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Hope Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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
2. Aged 18-59 years
3. Not currently taking PrEP and no plans to initiate during study
4. Not currently taking PEP
5. Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study
6. Willing to use condoms consistently for the duration of the study
7. Able to provide informed consent in English
8. No plans for relocation in the next 4 months
9. Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure
10. Willing to use study products as directed
11. Hepatitis B surface antigen (HBsAg) negative (screening lab test)
12. Creatinine clearance >60 ml/min

Exclusion Criteria:

1. Currently infected with hepatitis virus and/ or has liver disease
2. Current or chronic history of kidney disease or creatinine clearance (CrCl)<60 ml/min

3. Continued need for, or use during the 90 days prior to 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
4. Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) during the study, outside of the study procedures
5. Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures
6. 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
7. Not pregnant and no plans on getting pregnant throughout the duration of the study
8. Known allergic reaction to study drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Doxycycline and Biktarvy; Participants will take both study drugs simultaneously at home approximately 1 hour before Visit 2 and will be instructed to take a timestamped photograph or videotape of themselves taking the dose.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rectal Doxycycline Concentration	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.	24 hours after a single dose
Vaginal Doxycycline Concentration	Doxycycline concentration in tissue from a vaginal biopsy was measured.	24 hours after a single dose
Plasma Doxycycline Concentration	Doxycycline concentration in plasma was measured.	24 hours after a single dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rectal Bictegravir Concentration	Bectegravir concentration in tissue from a rectal biopsy was measured.	24 hours after a single dose
Vaginal Bictegravir Concentration	Bictegravir concentration in tissue from a vaginal biopsy was measured.	24 hours after a single dose

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Colleen Kelley, MD, MPH, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): May 9, 2022
• Study Completion (Actual): May 9, 2022

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Prevention; STI; PEP; Post-Exposure Prophylaxis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: STUDY00002242; 0000058968 (Other Grant/Funding Number: CDC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results published for this study (including text, tables, figures, and appendices), will be made available for sharing, after de-identification.
• IPD Sharing Time Frame: Data will be made available to researchers providing a methodologically sound proposal, beginning 9 months and ending 36 months following publication.
• IPD Sharing Access Criteria: Proposals should be directed to colleen.kelley@emory.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No