Biomarkers for Event-driven PrEP Adherence

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study aims to recruit 20 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times. Participants will then provide biologic samples for the measurement of anti-retroviral drug concentrations in various body compartment sites. Participants will be involved in the study for up to 24 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Collaborator: Centers for Disease Control and Prevention
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Criteria

Inclusion Criteria:

• 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

• <2 sexual partners in last 6 months

• Able to provide informed consent in English

• No plans for relocation in the next 4 months

• Willing to undergo peripheral blood, urine, hair, and finger stick 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 Criteria:

• 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.