NCT05334004 Lopinavir/Ritonavir in PLWH With High-Grade AIN
| NCT ID | NCT05334004 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Wisconsin, Madison |
| Condition | High-Grade Anal Intraepithelial Neoplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2023-12-19 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 21 participants in total. It began in 2023-12-19 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Evie Carchman, MD, FACS
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT05334004 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying High-Grade Anal Intraepithelial Neoplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05334004 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05334004 currently recruiting?
Yes, NCT05334004 is actively recruiting participants. Contact the research team at clinicaltrials@cancer.wisc.edu for enrollment information.
Where is the NCT05334004 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT05334004 clinical trial?
NCT05334004 is sponsored by University of Wisconsin, Madison. The principal investigator is Evie Carchman, MD, FACS at University of Wisconsin, Madison. The trial plans to enroll 21 participants.