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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)

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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

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.

About the study

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 being tested

• Lopinavir / Ritonavir (drug)

Sponsor: University of Wisconsin, Madison · Participants: 21 · Started: Dec 19, 2023

Contact the study team

• Cancer Connect, MD, FACS · Phone: 800-622-8922

Official record on ClinicalTrials.gov — NCT05334004

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.