Status:
COMPLETED
Biomarkers for Event-driven PrEP Adherence
Lead Sponsor:
Emory University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Human Immunodeficiency Virus
Eligibility:
MALE
18-59 years
Phase:
PHASE4
Brief Summary
This study aims to recruit 40 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times. Participants will then provide biologic samples for the mea...
Detailed Description
Men who have sex with men (MSM) continue to be disproportionately affected by HIV. In 2014, MSM made up approximately 2% of the U.S. population but accounted for 70% of the new HIV infections. The maj...
Eligibility Criteria
Inclusion
- HIV-negative person, who was assigned male at birth, who reports sex with another man in the last year, and is in good general health.
- Not currently taking PrEP and no plans to initiate during study
- Not currently taking PEP
- Consistent condom use and willing to use condoms 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, hair, finger stick, and optional hair sampling
- Willing to use study products as directed
- Hepatitis B surface antigen (HBsAg) must be negative (screening lab test)
- Creatinine clearance (CrCl) \>60 ml/min
Exclusion
- Currently infected with hepatitis virus and/ or has liver disease
- Current or chronic history of kidney disease or 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
- Current use of hormonal therapy
- 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
Key Trial Info
Start Date :
February 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04298697
Start Date
February 28 2020
End Date
August 9 2022
Last Update
September 19 2024
Active Locations (1)
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1
Hope Clinic
Atlanta, Georgia, United States, 30322