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

NCT05850728 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-12-11

No results posted yet for this study

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.

Conditions

  • Human Immunodeficiency Virus
  • Treatment
  • Antiretroviral Therapy

Interventions

DRUG

TLC-ART

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

Sponsors & Collaborators

Principal Investigators

  • Rachel A Bender Ignacio, MD MPH · University of Washington

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-06-28
Completion
2024-06-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT05850728 on ClinicalTrials.gov