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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: Completed Phase 4 study of HIV, sponsored by Philadelphia Fight.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cohort 1b: To determine how long TFV is excreted in the urine in patients at steady state of TAF/FTC. Ten healthy subjects will be given seven daily doses of TAF/FTC under direct observation to ensure adherence. Morning urine samples will be collected starting the day the last is given (1 hour later) and every day thereafter for 9 days (total of 10 days). Urine samples collected from all participants were analyzed via LC-MS/MS for tenofovir concentrations.
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 |
What the finished NCT03350672 record still lists
NCT03350672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03350672's enrollment target sits among peer trials
37 248th of 303 higher than 54 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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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