Lopinavir/Ritonavir in PLWH With High-Grade AIN
Recruiting · NCT05334004 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Wisconsin, Madison
View the official record on ClinicalTrials.gov →Interventions studied
Lopinavir / Ritonavir
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- UW Digestive Health Center Anoscopy Clinic - Madison, Wisconsin, United States