Lopinavir/Ritonavir in PLWH With High-Grade AIN

Recruiting now · Phase 1

Conditions studied: High-Grade Anal Intraepithelial Neoplasia

In brief

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.

Key facts

Study ID

NCT05334004

Run by

University of Wisconsin, Madison

People needed

21

Starts

2023-12-19

Expected to finish

2027-06-01

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• willing to provide informed consent
• greater than or equal to 18 years of age
• Diagnosis of biopsy-confirmed HGAIN
• willing to comply with all study procedures

You may not qualify if…

• 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.

Where it is running

• UW Digestive Health Center Anoscopy Clinic — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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