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Biomarkers for Event-driven PrEP Adherence

NCT04298697 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-09-19

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

Conditions

  • Human Immunodeficiency Virus

Interventions

DRUG

Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)

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 the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they are in. Participants will have biologic specimens collected at specific time points until 28 days after the last dose.

Sponsors & Collaborators

Principal Investigators

  • Colleen Kelley, MD, MPH · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-28
Primary Completion
2022-08-09
Completion
2022-08-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04298697 on ClinicalTrials.gov