RecruitingPhase 1

Lopinavir/Ritonavir in PLWH With High-Grade AIN

United States21 participantsStarted 2023-12-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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)

Timeframe: up to 5 weeks

Rate of Grade 3 or above Toxicities in any Organ System in the Escalation Cohorts

Timeframe: up to 5 weeks

Trial details

NCT IDNCT05334004

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Cancer Connect, MD, FACS

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

View on ClinicalTrials.gov More High-Grade Anal Intraepithelial Neoplasia trials