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NCT05334004 · ClinicalTrials.gov registry record · Phase 1
Lopinavir/Ritonavir in PLWH With High-Grade AIN
A Phase 1 study of High-Grade Anal Intraepithelial Neoplasia, sponsored by University of Wisconsin, Madison.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT05334004: Recruiting Phase 1 study of High-Grade Anal Intraepithelial Neoplasia, sponsored by University of Wisconsin, Madison.
NCT05334004 is a Phase 1 study of High-Grade Anal Intraepithelial Neoplasia that is actively recruiting participants, run by University of Wisconsin, Madison. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05334004, a Phase 1 study of High-Grade Anal Intraepithelial Neoplasia, is actively recruiting participants, sponsored by University of Wisconsin, Madison.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being done to assess the safety of lopinavir/ritonavir in patients with PLWH with AIN. 30 participants will be recruited and can expect to be on active study for approximately 3 months and long term follow up for 40 weeks.
Primary Outcome
The MTD is the highest explored dose of lopinavir/ritonavir is the dose at which less than 33% of patients experienced a DLT. A DLT is defined as any toxicity at least possibly related to ritonavir/lopinavir with a drug-related Grade greater than or equal to 3.
Conditions Studied
Interventions
- DRUG Lopinavir / Ritonavir
Study Locations (1)
Wisconsin
- UW Digestive Health Center Anoscopy Clinic - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2023-12-19 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What NCT05334004 shows while recruiting
NCT05334004 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 1 condition, with High-Grade Anal Intraepithelial Neoplasia appearing as the primary indexed condition, and to 1 intervention - of which Lopinavir / Ritonavir is the first listed.
NCT05334004 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05334004 about?
NCT05334004 is a clinical study titled "Lopinavir/Ritonavir in PLWH With High-Grade AIN". This study is being done to assess the safety of lopinavir/ritonavir in patients with PLWH with AIN. 30 participants will be recruited and can expect to be on active study for approximately 3 months and long term follow up for 40 weeks.
What is the current status of trial NCT05334004?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2023-12-19. Estimated completion is 2026-06.
What conditions does trial NCT05334004 study?
This clinical trial studies the following conditions: High-Grade Anal Intraepithelial Neoplasia.
What interventions are being tested in trial NCT05334004?
The interventions under investigation include: Lopinavir / Ritonavir (DRUG).
Who is sponsoring clinical trial NCT05334004?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05334004 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05334004's enrollment target sits among peer trials
21 1616th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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