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NCT03350672 · ClinicalTrials.gov registry record · Phase 4
Validation of a Urine Assay to Measure Tenofovir Levels in Patients Taking Tenofovir Alafenamide
A Phase 4 study of HIV, sponsored by Philadelphia Fight.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT03350672 is a Phase 4 study of HIV that has completed, run by Philadelphia Fight. The registered enrollment target is 37 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03350672, a Phase 4 study of HIV, has completed, sponsored by Philadelphia Fight.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
Pre-exposure prophylaxis (PrEP) with Truvada™ (tenofovir/emtricitabine), in which an HIV-uninfected individual at high risk for contracting HIV takes antiretroviral medications (one pill daily) to maintain blood and genital drug levels sufficient to prevent HIV-1 acquisition, has been validated in several large international trials that have included men who have sex with men and transgender women, heterosexual men and women, and people who use injection drugs, as a potential HIV-1 prevention strategy. HIV prevention interventions such as this, if adequately disseminated and implemented broadly, may help to curb new HIV infections, reduce HIV-associated morbidity and mortality, and reduce health disparities in HIV rates among the most at-risk individuals. Assuring adherence to a daily dose of PrEP is critical for effective protection against HIV infection. A urine-based test to measure PrEP medication levels in the body represents a non-invasive technique to assess adherence and ultimately improve PrEP's protective ability. TAF/FTC (Descovy™) is a new medication under study for HIV prevention to see if it is as effective as Truvada™. This study is testing whether a urine test can detect this medication in urine.
Conditions Studied
Interventions
- DRUG FTC/TAF
Study Locations (1)
Pennsylvania
- Philadelphia FIGHT - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2017-11-16 |
| Est. Completion | 2018-05-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03350672
The ClinicalTrials.gov registry entry for NCT03350672 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower). The listed sponsor is Philadelphia Fight, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 1 intervention - of which FTC/TAF is the first listed.
NCT03350672 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03350672 about?
NCT03350672 is a clinical study titled "Validation of a Urine Assay to Measure Tenofovir Levels in Patients Taking Tenofovir Alafenamide". Pre-exposure prophylaxis (PrEP) with Truvada™ (tenofovir/emtricitabine), in which an HIV-uninfected individual at high risk for contracting HIV takes antiretroviral medications (one pill daily) to maintain blood and genital drug levels sufficient to prevent HIV-1 acquisition, has been validated in s...
What is the current status of trial NCT03350672?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2017-11-16. Estimated completion is 2018-05-01.
What conditions does trial NCT03350672 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT03350672?
The interventions under investigation include: FTC/TAF (DRUG).
Who is sponsoring clinical trial NCT03350672?
This trial is sponsored by Philadelphia Fight, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03350672 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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