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NCT06274398 · ClinicalTrials.gov registry record · Phase 1
Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study
A Phase 1 study of Safety Issues, sponsored by Eastern Virginia Medical School.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT06274398: Completed Phase 1 study of Safety Issues, sponsored by Eastern Virginia Medical School.
NCT06274398 is a Phase 1 study of Safety Issues that has completed, run by Eastern Virginia Medical School. The registered enrollment target is 21 participants, below the 118-participant average among 13 other Safety Issues trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06274398, a Phase 1 study of Safety Issues, has completed, sponsored by Eastern Virginia Medical School.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days.
Primary Outcome
Safety measured by Grade 2 and higher adverse events (AEs)
Conditions Studied
Interventions
- DRUG TAF/EVG rectal insert
- DRUG Matching placebo rectal insert
Study Locations (1)
Georgia
- Emory Clinic - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-01-16 |
| Est. Completion | 2025-05-16 |
| Phase | Phase 1 |
What the finished NCT06274398 record still lists
NCT06274398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 118-participant average among 13 other Safety Issues trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Safety Issues appearing as the primary indexed condition, and to 2 interventions - of which TAF/EVG rectal insert is the first listed.
NCT06274398 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06274398 about?
NCT06274398 is a clinical study titled "Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study". This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days.
What is the current status of trial NCT06274398?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2024-01-16. Estimated completion is 2025-05-16.
What conditions does trial NCT06274398 study?
This clinical trial studies the following conditions: Safety Issues.
What interventions are being tested in trial NCT06274398?
The interventions under investigation include: TAF/EVG rectal insert (DRUG), Matching placebo rectal insert (DRUG).
Who is sponsoring clinical trial NCT06274398?
This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06274398 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
Similar trials for Safety Issues
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 NCT06274398's enrollment target sits among peer trials
21 10th of 13 higher than 3 of 13 other Safety Issues trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Safety Issues 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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