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 has two primary aims as follows:~To characterize the plasma concentration-time course and pharmacokinetics (PK) of a single dose of the drug substances of TLC-ART 101 (lopinavir, ritonavir, and tenofovir) administered by subcutaneous injection within the drug combination nanoparticle.~To characterize the safety and tolerability of a single subcutaneous injection of TLC-ART 101.~There are 4 exploratory mechanistic objectives (with related endpoints) as follows:~To characterize the pharmacokinetics of the drug substances in human peripheral blood mononuclear cells (PBMCs)~To characterize the concentrations of intracellular TFV-diphosphate (the active moiety of TFV) in PBMCs~To explore whether the pharmacokinetic parameters of the 3 drug substances differ by sex following a single dose~To compare lymphoid tissue mononuclear cell versus PBMC concentrations of the drug substances in TLC-ART 101.
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.