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

Emory University

Status and phase: Completed; Phase 4

Conditions: Sexually Transmitted Diseases

Treatments: Drug: Doxycycline; Drug: Biktarvy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04860505

STUDY00002242

0000058968 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Doxycycline and Biktarvy

Experimental group

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.

Treatment:

Drug: Doxycycline

Drug: Biktarvy