Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens

Launched by EMORY UNIVERSITY · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective the antibiotic doxycycline can be in preventing bacterial sexually transmitted infections (STIs). Specifically, researchers want to understand how much of the medication reaches certain tissues in the body after taking it daily for a week. The study is open to individuals assigned male or female at birth who are between the ages of 18 and 75 and in generally good health. Participants should not be currently taking doxycycline or similar antibiotics and must be willing to use condoms consistently during the study.

If you choose to participate, you will need to provide some health information and undergo a few tests, including blood and urine samples, as well as some biopsies. Importantly, you should not be pregnant or planning to become pregnant during the study. Those with certain health conditions or who are taking specific medications may not be eligible. This trial is currently recruiting participants, and your involvement could help shape future approaches to preventing STIs.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Assigned male sex or female sex at birth
• • In good general health
• • Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study
• • For HIV positive people, on stable antiretroviral therapy with an undetectable viral load and cluster of differentiation 4 (CD4) count\> 300ul/ml
• • Willing to use condoms consistently for the duration of the study
• • Able to provide informed consent
• • No plans for relocation in the next 4 months
• • Not pregnant and does not plan on getting pregnant for the duration of the study
• • 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
• Exclusion Criteria:
• • Current or chronic history of liver disease
• * 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 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
• • Known allergic reaction to study drugs
• * Significant laboratory abnormalities at baseline visit for rectal biopsies, including but not limited to:
• • Hemoglobin (Hgb) ≤ 10 g/dL
• • Partial thromboplastin time (PTT) \> 1.5x upper limit of normal (ULN) or international normalised ratio (INR) \> 1.5x ULN
• • Platelet count \<100,000