Lopinavir/Ritonavir in PLWH With High-Grade AIN

Last updated: May 13, 2025
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Recruiting

Phase

1

Condition

Genitourinary Cancer

Neoplasms

Precancerous Condition

Treatment

Lopinavir / Ritonavir

Clinical Study ID

NCT05334004
2023-0052
2022-0468 [former]
Protocol Version 7/1/2022
Protocol Version 6/15/2023
SMPH/SURGERY/COLON RECT
Protocol Version 6/6/2024
Protocol Version 3/21/2025
UW22123
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 200cells/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

Exclusion Criteria:

  • Diagnosis of low-grade anal dysplasia (AIN, low-grade squamous intraepitheliallesion (LSIL)) by HRA.

  • CD4 count less than 200 cells/mm^3 at the time of consideration for entry into thestudy

  • 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

Study Design

Total Participants: 21
Treatment Group(s): 1
Primary Treatment: Lopinavir / Ritonavir
Phase: 1
Study Start date:
December 19, 2023
Estimated Completion Date:
June 30, 2026

Study 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 described in arms below) in combination with variation in dosing schedules of the drug lopinavir/ritonavir. This design also allows for some possible intermediate doses to be examined if dose-limiting toxicities (DLTs) occur and de-escalation is needed.

An expansion cohort of 12 participants will occur at the MTD. Once the MTD is determined, then secondary outcomes will be evaluated.

Primary Objective

  • To evaluate the safety and tolerability of intra-anal administration of lopinavir/ritonavir, administered via suppository with 3 different schedules, in PLWH with high-grade anal intraepithelial neoplasia (HGAIN) (AIN 2/3).

Secondary Objectives

  • To measure the effect of intra-anal topical lopinavir/ritonavir administration

  • To evaluate clearance of human papillomavirus (HPV)

  • To elucidate the mechanism of action of protease inhibitors

Connect with a study center

  • UW Digestive Health Center Anoscopy Clinic

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

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