tenofovir alafenamide/elvitegravir vaginal insert (TAF/EVG vaginal insert) / CONRAD - LARVOL DELTA

Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert (clinicaltrials.gov) - P1 | N=68 | Completed | Sponsor: Eastern Virginia Medical School | Recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Dec 2024

Trial completion • Trial completion date

Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Eastern Virginia Medical School | Not yet recruiting ➔ Recruiting

Enrollment open

Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Eastern Virginia Medical School

New P1 trial

A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir. (PubMed, Front Cell Infect Microbiol) - P1 | "The inserts were safe and highly acceptable. ClinicalTrials.gov, identifier NCT03762772."

Journal • P1 data • PK/PD data • Herpes Simplex • Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] A phase I study to assess safety, pharmacokinetics and pharmacodynamics of a topical multipurpose prevention insert containing tenofovir alafenamide fumarate and elvitegravir dosed vaginally (HIVR4P 2021) - "BACKGROUND: A discreet, on-demand, vaginal or rectal, pre- or post-exposure prophylaxis product is unique and fills an important gap in human immunodeficiency virus (HIV) and herpes simplex virus type 2 (HSV-2) multipurpose prevention. A single vaginal dose of TAF/EVG topical insert was safe, acceptable and effective in preventing HIV-1 and HSV-2 infection ex vivo in this first-in-woman clinical study. PK data support an extended window of high mucosal exposure."

Clinical • P1 data • PK/PD data • Herpes Simplex • Human Immunodeficiency Virus • Immunology • Infectious Disease

[VIRTUAL] ON-DEMAND HIV POSTEXPOSURE PROPHYLAXIS BY TAF/EVG VAGINAL INSERTS IN MACAQUES (CROI 2020) - "CONRAD has developed a topical insert co-formulated with tenofovir alafenamide fumarate (TAF) and elvitegravir (EVG) to provide end-users a flexible on-demand dosing regimen that may align with their needs and lifestyle. The observed high levels of TFV-DP in PBMCs by topical delivery of TAF is unique and may have contributed to protection. Our data support the clinical development of TAF/EVG inserts for on-demand PrEP/PEP for HIV prevention."