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Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Considered for Future On-demand Peri-exposure HIV Prophylaxis Regimens

NCT03976752 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-08-13

Study results available
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Summary

This study is being conducted to determine if the uptake of anti-HIV medication, called Genvoya®, at different time-frames, is different at several body sites, including mucosal tissues. This medication might be considered for on-demand PEP regimens in the future.

Conditions

Interventions

DRUG

Genvoya

Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat. At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic.

Sponsors & Collaborators

Principal Investigators

  • Colleen Kelley, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-13
Primary Completion
2019-09-20
Completion
2019-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT03976752 on ClinicalTrials.gov