Status:
RECRUITING
Lopinavir/Ritonavir in PLWH With High-Grade AIN
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Wisconsin Partnership Program
Conditions:
High-Grade Anal Intraepithelial Neoplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 a...
Detailed Description
This is a Phase I modified 3 + 3 design, in which the maximum tolerated dose (MTD) will be identified. The 3 + 3 dose escalation will consist of 6 dose levels (18 participants; planned escalation desc...
Eligibility Criteria
Inclusion
- willing to provide informed consent
- greater than or equal to 18 years of age
- Diagnosis of biopsy-confirmed HGAIN
- Human immunodeficiency virus (HIV)-positive with CD4 count greater than 200 cells/mm\^3 at screening and virologically suppressed on HIV-1 antiretroviral therapy (ART) within last 12 months
- willing to comply with all study procedures
Exclusion
- Diagnosis of low-grade anal dysplasia (AIN, low-grade squamous intraepithelial lesion (LSIL)) by HRA.
- CD4 count less than 200 cells/mm\^3 at the time of consideration for entry into the study
- unable to provide informed consent
- Pregnant or breastfeeding female
- Currently receiving systemic chemotherapy or radiation therapy for another cancer.
- Have received topical therapy for anal dysplasia previously
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05334004
Start Date
December 19 2023
End Date
June 1 2026
Last Update
May 15 2025
Active Locations (1)
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1
UW Digestive Health Center Anoscopy Clinic
Madison, Wisconsin, United States, 53705