Back to resultsCombo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
Primary Purpose
Sexually Transmitted Diseases
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Doxycycline
Biktarvy
Sponsored by
About this trial
This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring Post-Exposure Prophylaxis, HIV, STI, PEP, Prevention
Eligibility Criteria
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
Sites / Locations
- Hope Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Doxycycline and Biktarvy
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Vaginal Doxycycline Concentration
Doxycycline concentration in tissue from a vaginal biopsy was measured.
Plasma Doxycycline Concentration
Doxycycline concentration in plasma was measured.
Secondary Outcome Measures
Rectal Bictegravir Concentration
Bectegravir concentration in tissue from a rectal biopsy was measured.
Vaginal Bictegravir Concentration
Bictegravir concentration in tissue from a vaginal biopsy was measured.
Full Information
NCT ID
NCT04860505
First Posted
April 22, 2021
Last Updated
April 26, 2023
Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04860505
Brief Title
Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
Official Title
Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
May 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (STI) Post-exposure Prophylaxis (PEP).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases
Keywords
Post-Exposure Prophylaxis, HIV, STI, PEP, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doxycycline and Biktarvy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Biktarvy
Intervention Description
Biktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.
Primary Outcome Measure Information:
Title
Rectal Doxycycline Concentration
Description
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.
Time Frame
24 hours after a single dose
Title
Vaginal Doxycycline Concentration
Description
Doxycycline concentration in tissue from a vaginal biopsy was measured.
Time Frame
24 hours after a single dose
Title
Plasma Doxycycline Concentration
Description
Doxycycline concentration in plasma was measured.
Time Frame
24 hours after a single dose
Secondary Outcome Measure Information:
Title
Rectal Bictegravir Concentration
Description
Bectegravir concentration in tissue from a rectal biopsy was measured.
Time Frame
24 hours after a single dose
Title
Vaginal Bictegravir Concentration
Description
Bictegravir concentration in tissue from a vaginal biopsy was measured.
Time Frame
24 hours after a single dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Kelley, MD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hope Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
We'll reach out to this number within 24 hrs