RecruitingPhase 1NCT05334004
Lopinavir/Ritonavir in PLWH With High-Grade AIN
A Phase I Study of Intra-anally Administered Lopinavir/Ritonavir in People Living With HIV (PLWH) With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
Sponsor
University of Wisconsin, Madison
Enrollment
21 participants
Start Date
Dec 19, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria5
- 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.
Interventions
DRUGLopinavir / Ritonavir
Human Immunodeficiency Virus (HIV) antiviral, given via suppository
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05334004