Biomarkers for Event-driven PrEP Adherence

Completed · Phase 4

Conditions studied: Human Immunodeficiency Virus

In brief

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 measurement of anti-retroviral drug concentrations in various body compartment sites. Participants will be involved in the study for up to 24 weeks.

Key facts

Study ID

NCT04298697

Run by

Emory University

People needed

43

Starts

2020-02-28

Expected to finish

2022-08-09

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 59. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hope Clinic — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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