Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT05853120
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-59 years
* 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 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 before 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
* Intent to use doxycycline or other tetracycline-derived antibiotics during 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:
1. Hgb ≤ 10 g/dL
2. PTT \> 1.5x ULN or INR \> 1.5x ULN
3. Platelet count \<100,000
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT05853120
Study Brief:
Protocol Section:
NCT05853120