RecruitingPhase 1NCT05334004

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)


Sponsor

University of Wisconsin, Madison

Enrollment

21 participants

Start Date

Dec 19, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether lopinavir/ritonavir — an antiretroviral medication originally used for HIV — can treat high-grade anal dysplasia (a pre-cancerous condition of the anal canal) in people living with HIV. **You may be eligible if...** - You are 18 or older and living with HIV - You have been diagnosed with high-grade anal intraepithelial neoplasia (HGAIN), confirmed by biopsy - Your CD4 immune cell count is above 200 cells/mm³ - Your HIV is well-controlled on antiretroviral therapy **You may NOT be eligible if...** - You have only low-grade anal dysplasia - Your CD4 count is below 200 cells/mm³ - You are pregnant or breastfeeding - You are currently receiving chemotherapy or radiation for another cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLopinavir / Ritonavir

Human Immunodeficiency Virus (HIV) antiviral, given via suppository


Locations(1)

UW Digestive Health Center Anoscopy Clinic

Madison, Wisconsin, United States

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NCT05334004