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Lopinavir/Ritonavir in PLWH With High-Grade AIN

RECRUITINGPhase 1Sponsored by University of Wisconsin, Madison
Actively Recruiting
PhasePhase 1
SponsorUniversity of Wisconsin, Madison
Started2023-12-19
Est. completion2026-06
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05334004

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

Age: 18 Years+Healthy volunteers accepted
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 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

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.

Conditions2

CancerHigh-Grade Anal Intraepithelial Neoplasia

Locations1 site

UW Digestive Health Center Anoscopy Clinic
Madison, Wisconsin, 53705

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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