elvitegravir/tenofovir alafenamide insert (TAF/EVG insert) / CONRAD, National Institute of Allergy and Infectious Diseases - LARVOL DELTA

Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study (clinicaltrials.gov) - P1 | N=21 | Completed | Sponsor: Eastern Virginia Medical School | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ May 2025 | Trial primary completion date: Oct 2024 ➔ Mar 2025

Trial completion • Trial completion date • Trial primary completion date

Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Eastern Virginia Medical School

New P1 trial

Pharmacokinetics and efficacy of topical inserts containing tenofovir alafenamide fumarate and elvitegravir administered rectally in macaques. (PubMed, EBioMedicine) - "Although high TFV-DP and EVG levels were observed with one rectal TAF/EVG insert, it only conferred partial protection from rectal SHIV challenges. Adding a second insert led to an increase in TFV and EVG in rectal tissues resulting in higher (>90%) efficacy. These results highlight the high efficacy of TAF/EVG inserts as topical on-demand rectal PrEP, as well as the need for appropriate drug coverage in the deep rectum and colon to achieve high protection."

Journal • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVC) Administered Rectally (clinicaltrials.gov) - P1; N=23; Completed; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Recruiting ➔ Completed

Clinical • Trial completion • Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] PHARMACOKINETICS OF TAF/EVG RECTAL INSERTS IN MACAQUES AND IMPACT OF RECTAL WASH (CROI 2021) - "CONRAD has developed inserts containing tenofovir alafenamide fumarate (TAF) and elvitegravir (EVG) for on-demand vaginal or rectal pericoital use. Rectal application of TAF/EVG inserts resulted in tissue EVG and TFV-DP levels at 4 hours that were high and within the range of those associated with vaginal protection. Rectal wash was associated with extended biodistribution of TFV-DP and EVG throughout the rectum and increased tissue drug levels by several orders of magnitude. SHIV challenge studies will help define the rectal protection achieved with TAF/EVG inserts."

PK/PD data • Human Immunodeficiency Virus • Infectious Disease

Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVC) Administered Rectally (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Trial completion date: Aug 2020 ➔ Mar 2021; Trial primary completion date: Aug 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVC) Administered Rectally (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Gene Therapies • Human Immunodeficiency Virus • Infectious Disease

Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVC) Administered Rectally (clinicaltrials.gov) - P1; N=20; Active, not recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Gene Therapies • Genetic Disorders • Human Immunodeficiency Virus • 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."

Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVC) Administered Rectally (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Not yet recruiting ➔ Recruiting

Clinical • Enrollment open