NCT05334004RecruitingPhase 1
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)
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 1 Apr 2022
- Start date
- 19 Dec 2023
- Primary completion date
- Jun 2027
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- HIV
- NCT number
- NCT05334004
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 21
- From 19 Dec 2023 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving systemic chemotherapy or radiation therapy for another cancer.
Lab values
- CD4 count less than 200 cells/mm\^3 at the time of consideration for entry into the study
Other
- Diagnosis of low-grade anal dysplasia (AIN, low-grade squamous intraepithelial lesion (LSIL)) by HRA.
- unable to provide informed consent
- Pregnant or breastfeeding female
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UW Digestive Health Center Anoscopy Clinic Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.