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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: Completed Phase 1 study of Human Immunodeficiency Virus and Treatment, sponsored by University of Washington.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The maximum drug substance plasma concentrations of lopinavir, ritonavir, and tenofovir obtained following a single administration. Sampling for drug concentrations was performed at 15-, 30-, and 45-minutes post-dosing; at 1, 3, 5, 8, and 24 hours; and after 2, 3, 7, 10, 14, 21, 28, 35, 49, and 57 days in Cohort 1. Cohort 2A/2B members had an additional sample drawn at 64 days.
Conditions Studied
Interventions
- DRUG TLC-ART
Study Locations (1)
Washington
- UW Positve Research, Harborview Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-04-01 |
| Est. Completion | 2024-06-28 |
| Phase | Phase 1 |
What the finished NCT05850728 record still lists
NCT05850728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 184-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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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Where NCT05850728's enrollment target sits among peer trials
12 39th of 39 higher than 1 of 39 other Human Immunodeficiency Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Immunodeficiency Virus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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