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NCT05850728 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Human Immunodeficiency Virus and Treatment, sponsored by University of Washington.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT05850728 is a Phase 1 study of Human Immunodeficiency Virus and Treatment that has completed, run by University of Washington. The registered enrollment target is 12 participants, below the 184-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05850728, a Phase 1 study of Human Immunodeficiency Virus and Treatment, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target
1
Study location

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.

Interventions

  • DRUG TLC-ART

Study Locations (1)

Washington

  • UW Positve Research, Harborview Medical Center - Seattle

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2023-04-01
Est. Completion 2024-06-28
Phase Phase 1

Sponsor

University of Washington

1,048 total trials

What the Registry Record Tells You About NCT05850728

The ClinicalTrials.gov registry entry for NCT05850728 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 184-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (93% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Human Immunodeficiency Virus appearing as the primary indexed condition, and to 1 intervention - of which TLC-ART is the first listed.

NCT05850728 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT05850728 about?

NCT05850728 is a clinical study titled "First in Human Study of TLC-ART 101 (ACTU 2001)". 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 form...

What is the current status of trial NCT05850728?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2023-04-01. Estimated completion is 2024-06-28.

What conditions does trial NCT05850728 study?

This clinical trial studies the following conditions: Human Immunodeficiency Virus, Treatment, Antiretroviral Therapy.

What interventions are being tested in trial NCT05850728?

The interventions under investigation include: TLC-ART (DRUG).

Who is sponsoring clinical trial NCT05850728?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05850728 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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