Recruiting
Phase 1

Lopinavir/Ritonavir

Sponsor:

University of Wisconsin, Madison

Code:

NCT05334004

Conditions

High-Grade Anal Intraepithelial Neoplasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lopinavir / Ritonavir

Study Details

Brief 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.

Conditions

High-Grade Anal Intraepithelial Neoplasia

Study ID

NCT05334004

Start date

Dec 19, 2023

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

21 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Lopinavir/Ritonavir 200mg/50mg (2 cycles)

Cohort 1 will receive two 5-day cycles of the low dose of the suppository (Lopinavir/Ritonavir (200mg/50mg)) in Weeks 0 and 2

experimental: Cohort 1b: Lopinavir/Ritonavir 200mg/50mg (3 cycles)

Cohort 1b will receive three 5-day cycles of the low dose of the suppository (Lopinavir/Ritonavir (200mg/50mg)) in Weeks 0, 2, and 4 if Cohort 2 has one dose-limiting toxicity (DLT).

experimental: Cohort 2: Lopinavir/Ritonavir 400mg/100mg (2 cycles)

Cohort 2 will receive two 5-day cycles of the higher dose of the suppository (Lopinavir/Ritonavir (400mg/100mg)) in Weeks 0 and 2, if Cohort 1 dose is safe.

experimental: Cohort 2b: Lopinavir/Ritonavir 400mg/100mg (3 cycles)

Cohort 2b will receive three 5-day cycle of the higher dose of the suppository (Lopinavir/Ritonavir (400mg/100mg)) in Weeks 0, 2 and 4 if Cohort 3 has one DLT.

experimental: Cohort 3: Lopinavir/Ritonavir 600mg/150mg (2 cycles)

Cohort 3 will receive two 5-day cycles of the highest dose of the suppository (Lopinavir/Ritonavir (600mg/150mg)) in Weeks 0 and 2, if the Cohort 2 dose is safe.

experimental: Cohort 4: Lopinavir/Ritonavir 600mg/150mg (3 cycles)

Cohort 4 will receive three 5-day cycles of the highest dose of the suppository (Lopinavir/Ritonavir (600mg/150mg)) in Weeks 0, 2, and 4, if the Cohort 3 dose is safe.

Interventions

Lopinavir / Ritonavir

Human Immunodeficiency Virus (HIV) antiviral, given via suppository

Primary outcome measure

  • Maximum Tolerated Dose (MTD) as determined by the number of participants at each dose level in the escalation cohorts who experienced a dose-limiting toxicity (DLT) [ Time Frame: up to 5 weeks ]
  • Rate of Grade 3 or above Toxicities in any Organ System in the Escalation Cohorts [ Time Frame: up to 5 weeks ]

Central Contacts and Locations

Central contacts

Cancer Connect, MD, FACS

800-622-8922clinicaltrials@cancer.wisc.edu

Locations

UW Digestive Health Center Anoscopy Clinic

Recruiting

Madison, Wisconsin, United States, 53705

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

May 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-05-15.