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NCT04298697 · ClinicalTrials.gov registry record · Phase 4
Biomarkers for Event-driven PrEP Adherence
A Phase 4 study of Human Immunodeficiency Virus, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT04298697: Completed Phase 4 study of Human Immunodeficiency Virus, sponsored by Emory University.
NCT04298697 is a Phase 4 study of Human Immunodeficiency Virus that has completed, run by Emory University. The registered enrollment target is 43 participants, below the 183-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04298697, a Phase 4 study of Human Immunodeficiency Virus, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to recruit 40 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times. Participants will then provide biologic samples for the measurement of anti-retroviral drug concentrations in various body compartment sites. Participants will be involved in the study for up to 24 weeks.
Primary Outcome
Concentration of TFV-DP was measured 24 hours after the last dose to compare accumulation of drug following weekly event-driven PrEP (ED-PrEP) dosing. Dried blood spot samples were collected from participants using a 6 millimeter (mm) dried blood spot card punch system.
Conditions Studied
Interventions
- DRUG Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)
Study Locations (1)
Georgia
- Hope Clinic - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2020-02-28 |
| Est. Completion | 2022-08-09 |
| Phase | Phase 4 |
What the finished NCT04298697 record still lists
NCT04298697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 183-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Human Immunodeficiency Virus appearing as the primary indexed condition, and to 1 intervention - of which Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is the first listed.
NCT04298697 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04298697 about?
NCT04298697 is a clinical study titled "Biomarkers for Event-driven PrEP Adherence". This study aims to recruit 40 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times. Participants will then provide biologic samples for the measurement of anti-retroviral drug concentrations in various body compartment sites. Participants will...
What is the current status of trial NCT04298697?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2020-02-28. Estimated completion is 2022-08-09.
What conditions does trial NCT04298697 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus.
What interventions are being tested in trial NCT04298697?
The interventions under investigation include: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (DRUG).
Who is sponsoring clinical trial NCT04298697?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04298697 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04298697's enrollment target sits among peer trials
43 25th of 39 higher than 15 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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