Using Lopinavir/Ritonavir for High-Grade Anal Neoplasia in HIV-Positive Patients
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)
This study is testing if a medication called lopinavir/ritonavir, given as a suppository, is safe and effective for people with HIV who have a serious condition called high-grade anal neoplasia.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05334004 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and tolerability of intra-anal administration of lopinavir/ritonavir in patients living with HIV who have high-grade anal intraepithelial neoplasia (HGAIN). The study will utilize a modified 3 + 3 dose escalation design to identify the maximum tolerated dose (MTD) of the drug, with 30 participants expected to be involved over approximately 3 months, followed by long-term follow-up. Participants will receive the medication via suppository with varying dosing schedules, and secondary outcomes will include measuring the effect on HPV clearance and understanding the mechanism of action of the drug.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive individuals aged 18 and older with biopsy-confirmed high-grade anal intraepithelial neoplasia and a CD4 count greater than 200 cells/mm^3.
Not a fit: Patients with low-grade anal dysplasia, those with a CD4 count below 200 cells/mm^3, or those currently undergoing systemic chemotherapy or radiation therapy for another cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with high-grade anal neoplasia, potentially improving their health outcomes.
How similar studies have performed: While this approach is novel in the context of using lopinavir/ritonavir for this specific condition, similar studies have explored the use of protease inhibitors in other contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madison, Wisconsin
- UW Digestive Health Center Anoscopy Clinic — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Evie Carchman, MD, FACS — University of Wisconsin, Madison
- Study coordinator: Cancer Connect, MD, FACS
- Email: clinicaltrials@cancer.wisc.edu
- Phone: 800-622-8922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.