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NCT05335590 · ClinicalTrials.gov registry record
Adherence and Clinical Correlates in Persons With HIV on TAF
A clinical trial of HIV, sponsored by University of Colorado, Denver.
- Active
- Registry status
- 384
- Enrollment target
- 1
- Study location
NCT05335590: Active study of HIV, sponsored by University of Colorado, Denver.
NCT05335590 is a study of HIV that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 384 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (13% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05335590, a study of HIV, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- 384 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an observational, 48-week, prospective study of PWH treated with TAF in which the investigators will compare TFV-DP concentrations in DBS in virologically suppressed vs. non-suppressed individuals and evaluate the utility of TFV-DP in DBS to predict future viremia. To accomplish this, the investigators will approach PWH currently taking TAF (which is being prescribed by a primary care physician) and who present to the clinic for regular HIV care and HIV VL assessment. Participants will complete up to 3 visits (at least 2 weeks apart) during the 48-week study follow-up period.
Primary Outcome
HIV viral load, binary cutoff at assay level of detection (\<20 copies/mL vs \>= 20 copies/mL); reference group lowest adherence category for TFV-DP; adjusted odds ratio calculated using generalized estimated equations; concentration cutoffs established in prior research of healthy volunteers and persons with HIV (PWH)
Conditions Studied
Study Locations (1)
Colorado
- University of Colorado Health - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2022-04-25 |
| Est. Completion | 2026-03 |
What the registry record for NCT05335590 still lists
NCT05335590 is an observational study that tracks outcomes without assigning an intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 303 other HIV trials with a reported enrollment target (13% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 0 interventions.
NCT05335590 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05335590 about?
NCT05335590 is a clinical study titled "Adherence and Clinical Correlates in Persons With HIV on TAF". This is an observational, 48-week, prospective study of PWH treated with TAF in which the investigators will compare TFV-DP concentrations in DBS in virologically suppressed vs. non-suppressed individuals and evaluate the utility of TFV-DP in DBS to predict future viremia. To accomplish this, the in...
What is the current status of trial NCT05335590?
This trial is currently active not recruiting. The enrollment target is 384 participants. The study started on 2022-04-25. Estimated completion is 2026-03.
What conditions does trial NCT05335590 study?
This clinical trial studies the following conditions: HIV.
Who is sponsoring clinical trial NCT05335590?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05335590 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05335590's enrollment target sits among peer trials
384 51st of 303 higher than 253 of 303 other HIV trials
participants (enrollment target), bucketed by value
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