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

NCT04860505 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: STUDY000022420000058968
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sexually Transmitted Diseases

Keywords

Post-Exposure Prophylaxis; HIV; STI; PEP; Prevention

Outcome Measures

Primary Outcomes (3)

• 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

• Vaginal Doxycycline Concentration

  Doxycycline concentration in tissue from a vaginal biopsy was measured.

  24 hours after a single dose

• Plasma Doxycycline Concentration

  Doxycycline concentration in plasma was measured.

  24 hours after a single dose

Secondary Outcomes (2)

• Rectal Bictegravir Concentration

  24 hours after a single dose

• Vaginal Bictegravir Concentration

  24 hours after a single dose

Study Arms (1)

Doxycycline and Biktarvy

EXPERIMENTAL

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; Drug: Biktarvy

Interventions

Doxycycline 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.

Doxycycline and Biktarvy

Biktarvy DRUG

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

Doxycycline and Biktarvy

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Hope Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Doxycycline; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Colleen Kelley
• Organization: Emory University

colleen.kelley@emory.edu

404-712-1823

Study Officials

• Colleen Kelley, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: May 20, 2021
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: May 23, 2023
• Results First Posted: May 23, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available to researchers providing a methodologically sound proposal, beginning 9 months and ending 36 months following publication.
• Access Criteria: Proposals should be directed to colleen.kelley@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)