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NCT03762772 · ClinicalTrials.gov registry record · Phase 1
Safety, PK, and PD Study of a Vaginal Insert Containing TAF and EVG
A Phase 1 study of HIV and HSV, sponsored by CONRAD.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03762772: Completed Phase 1 study of HIV and HSV, sponsored by CONRAD.
NCT03762772 is a Phase 1 study of HIV and HSV that has completed, run by CONRAD. The registered enrollment target is 16 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03762772, a Phase 1 study of HIV and HSV, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this Phase I study is to assess the safety, pharmacokinetics, and pharmacodynamics of a combination vaginal insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG). This study will be the first-in-human study for a vaginally administered TAF/EVG insert and will evaluate safety, PK and PD after a single dose. It is hypothesized that the combination insert will be safe and well-tolerated by study participants and that the insert will offer an expanded window of preventive activity and a regimen with flexibility and forgiveness.
Primary Outcome
TEAEs are defined as adverse events starting or worsening after administration of the study product; Grade is determined by the DAIDS Grading Table
Interventions
- DRUG TAF/EVG Vaginal Insert
Study Locations (1)
Virginia
- Clinical Research Center at Eastern Virginia Medical School (NOT RECRUITING ADDITIONAL SITES) - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-12-10 |
| Est. Completion | 2019-03-20 |
| Phase | Phase 1 |
What the finished NCT03762772 record still lists
NCT03762772 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 1 intervention - of which TAF/EVG Vaginal Insert is the first listed.
NCT03762772 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03762772 about?
NCT03762772 is a clinical study titled "Safety, PK, and PD Study of a Vaginal Insert Containing TAF and EVG". The purpose of this Phase I study is to assess the safety, pharmacokinetics, and pharmacodynamics of a combination vaginal insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG). This study will be the first-in-human study for a vaginally administered TAF/EVG insert and will evaluate ...
What is the current status of trial NCT03762772?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-12-10. Estimated completion is 2019-03-20.
What conditions does trial NCT03762772 study?
This clinical trial studies the following conditions: HIV, HSV.
What interventions are being tested in trial NCT03762772?
The interventions under investigation include: TAF/EVG Vaginal Insert (DRUG).
Who is sponsoring clinical trial NCT03762772?
This trial is sponsored by CONRAD, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03762772 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03762772's enrollment target sits among peer trials
16 288th of 303 higher than 15 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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