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

Sponsor

Emory University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04860505

Collaborator

Centers for Disease Control and Prevention (U.S. Fed)

Enrollment

Location

Arm

22.4

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Sexually Transmitted Diseases	Drug: Doxycycline Drug: Biktarvy	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 20, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rectal doxycycline concentration [24 hours after a single dose]
Rectal doxycycline concentration will be measured
Vaginal doxycycline concentration [24 hours after a single dose]
Vaginal doxycycline concentration will be measured
Plasma doxycycline concentration [24 hours after a single dose]
Plasma doxycycline concentration will be measured

Secondary Outcome Measures

Rectal Biktarvy concentration [24 hours after a single dose]
Rectal anti-retroviral drug concentration will be measured
Vaginal Biktarvy concentration [24 hours after a single dose]
Vaginal anti-retroviral drug concentration will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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