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

NCT ID: NCT04860505

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2022-05-09

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.

Conditions

Sexually Transmitted Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Doxycycline

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Biktarvy

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Colleen Kelley

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colleen Kelley, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Hope Clinic

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

0000058968

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00002242

Identifier Type: -

Identifier Source: org_study_id