Lopinavir/Ritonavir in PLWH With High-Grade AIN

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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 study for up to 40 weeks.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Wisconsin Partnership Program
• Treatments: Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• willing to provide informed consent

• greater than or equal to 18 years of age

• Human papillomavirus (HPV) positive

• Diagnosis of HGAIN

• Human immunodeficiency virus (HIV) positive with CD4 count greater than 200 cells/mm^3

• willing to comply with all study procedures

Exclusion Criteria:

• 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.

• Lipid profile abnormalities

• total cholesterol greater than 240 mg/dL

• low density lipoproteins (LDL) greater than 160 mg/dL

• high density lipoproteins (HDL) less than 40 mg/dL

• triglycerides greater than 500 mg/dL

• Have received topical therapy for anal dysplasia previously