Phase 4
Completed N=20
Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
Source: ClinicalTrials.gov NCT04860505 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Rectal Doxycycline Concentration — 0.654 µg/g
◆ Published Evidence
Not yet cited
0citations
Chelating anticoagulants reduce plasma doxycycline measurements: implications for doxy PEP monitoring.
Summary
The study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (STI) Post-exposure Prophylaxis (PEP).
Linked Publications
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Chelating anticoagulants reduce plasma doxycycline measurements: implications for doxy PEP monitoring.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rectal Doxycycline Concentration |
0.654 | — |
| PRIMARY Vaginal Doxycycline Concentration |
0.367 | — |
| PRIMARY Plasma Doxycycline Concentration |
487 | — |
| SECONDARY Rectal Bictegravir Concentration |
0.085 | — |
| SECONDARY Vaginal Bictegravir Concentration |
0.207 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04860505) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.