RECRUITING

Lopinavir/Ritonavir in PLWH With High-Grade AIN

Description

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
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Related Conditions:

High-Grade Anal Intraepithelial Neoplasia

Study Overview

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Study Details

Study overview

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.

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)

Lopinavir/Ritonavir in PLWH With High-Grade AIN

Condition
High-Grade Anal Intraepithelial Neoplasia
Intervention / Treatment

-

Contacts and Locations

Madison

UW Digestive Health Center Anoscopy Clinic, Madison, Wisconsin, United States, 53705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 200 cells/mm\^3 at screening and virologically suppressed on HIV-1 antiretroviral therapy (ART) within last 12 months
  • * willing to comply with all study procedures
  • * 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.
  • * Have received topical therapy for anal dysplasia previously

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Wisconsin, Madison,

Evie Carchman, MD, FACS, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

2025-06