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COMPLETED
NCT05850728
PHASE1

First in Human Study of TLC-ART 101 (ACTU 2001)

Sponsor: University of Washington

View on ClinicalTrials.gov

Summary

This study is a prospective, open-label, single-site, first-in-human study of a long-acting, injectable combination antiretroviral therapy platform, with a pharmacologically-guided adaptive design for dose escalation, de-escalation, and study duration. The study is designed to learn whether the formulation can be used as a platform for other drugs for treatment of HIV. The formulation is a drug combination nanoparticle (DCNP). The study will be conducted by UW Positive Research. The sample size for this study is 12-16. The study population consists of healthy adults without HIV. The study duration is 57 days per participant at the start of the study.

Official title: First in Human Clinical Trial of a Next Generation, Long-acting Injectable, Combination Antiretroviral Therapy Platform

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2023-04-01

Completion Date

2024-06-28

Last Updated

2026-08-21

Healthy Volunteers

Yes

Interventions

DRUG

TLC-ART

TLC-ART 101 contains lopinavir, ritonavir, and tenofovir in a combination nanoparticle suspension

Locations (1)

UW Positve Research, Harborview Medical Center

Seattle, Washington, United States