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

Sexually Transmitted Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04860505
• Other study ID #: STUDY00002242
• Secondary ID: 0000058968
• Status: Completed
• Phase: Phase 4
• Start date: May 20, 2021
• Est. completion date: May 9, 2022

Study information

• Verified date: April 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Sexually Transmitted Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Hope Clinic	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Vaginal Doxycycline Concentration	Doxycycline concentration in tissue from a vaginal biopsy was measured.	24 hours after a single dose
Primary	Plasma Doxycycline Concentration	Doxycycline concentration in plasma was measured.	24 hours after a single dose
Secondary	Rectal Bictegravir Concentration	Bectegravir concentration in tissue from a rectal biopsy was measured.	24 hours after a single dose
Secondary	Vaginal Bictegravir Concentration	Bictegravir concentration in tissue from a vaginal biopsy was measured.	24 hours after a single dose