Clinical trial

Biomarkers for Event-driven PrEP Adherence

Name

IRB00116781

Description

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.

Trial arms

Trial start

2020-02-28

Estimated PCD

2022-08-09

Trial end

2022-08-09

Status

Completed

Phase

Early phase I

Treatment

TDF/FTC Dose Schedule for Arm A

TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants will take 2 pills on Study Day 1, then one pill per day on Study Days 2 and 3. Participants will have biologic specimens collected at specific time points until 28 days after the last dose.

Arms:

TDF/FTC for one week

Other names:

Truvada

TDF/FTC Dose Schedule for Arm B

TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants will be on a weekly dosing schedule of 2 pills on the first day, followed by one pill per day for the next two days. They will follow this dosing schedule for four weeks. Participants will have biologic specimens collected at specific time points until 28 days after the last dose.

Arms:

TDF/FTC for four weeks

Other names:

Truvada

Size

Primary endpoint

Tenofovir-diphosphate (TFV-DP) Concentration

24 Hours After Last Dose (Day 4 for Arm A, Day 29 for Arm B)

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

Updated at

2024-04-15

1 organization

1 product

1 indication

Organization

Emory University

Product

TDF/FTC

Indication

HIV