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Protease Inhibitor
Lopinavir/Ritonavir for Anal Intraepithelial Neoplasia
Phase 1
Recruiting
Led By Evie Carchman, MD, FACS
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Greater than or equal to 18 years of age
Diagnosis of biopsy-confirmed HGAIN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12, week 40
Awards & highlights
Study Summary
This trial is testing the safety of lopinavir/ritonavir in patients with both HIV and anal intraepithelial neoplasia. Thirty participants will be monitored for up to 40 weeks.
Who is the study for?
This trial is for adults over 18 with HIV who are virologically suppressed on ART, have a CD4 count above 200 cells/mm^3, and are HPV positive with high-grade anal intraepithelial neoplasia (HGAIN). It's not for those with low-grade AIN, CD4 counts under 200, abnormal lipid profiles, pregnant or breastfeeding women, anyone on chemotherapy/radiation for another cancer or who've had topical therapy for anal dysplasia.Check my eligibility
What is being tested?
The study tests the safety of lopinavir/ritonavir in patients living with HIV who have HGAIN. Thirty participants will be involved in active study treatment for about three months and then followed up long-term for an additional forty weeks to monitor effects.See study design
What are the potential side effects?
Potential side effects of lopinavir/ritonavir may include digestive issues like diarrhea and nausea; changes in body fat distribution; increased cholesterol or triglyceride levels; possible liver problems; immune system changes; and potential interactions with other drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with high-grade anal intraepithelial neoplasia.
Select...
I have tested positive for HPV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12, week 40
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12, week 40
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) as determined by the number of participants at each dose level in the escalation cohorts who experienced a dose-limiting toxicity (DLT)
Heart rate
Secondary outcome measures
Number of Participants in the Expansion Cohort Determined clear of HPV by PCR test
Number of Participants in the Expansion Cohort Who Experience Regression of AIN2/3 Determined by Pathology
Human papillomavirus
+4 moreSide effects data
From 2017 Phase 1 trial • 60 Patients • NCT0307047030%
Headache
20%
Atrioventricular Block Second Degree
20%
Nausea
20%
Skin Reaction
10%
Chalazion
10%
Constipation
10%
Dizziness
10%
Vessel Puncture Site Pain
10%
Vessel Puncture Site Phlebitis
10%
Vessel Puncture Site Swelling
10%
Bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dofetilide and Diltiazem
Ranolazine
Verapamil
Lopinavir / Ritonavir
Chloroquine
Placebo
Trial Design
6Treatment groups
Experimental Treatment
Group I: Cohort 4: Lopinavir/Ritonavir 600mg/150mg (3 cycles)Experimental Treatment1 Intervention
Cohort 4 will receive three 5-day cycles of the highest dose of the suppository (Lopinavir/Ritonavir (600mg/150mg)) in Weeks 0, 2, and 4, if the Cohort 3 dose is safe.
Group II: Cohort 3: Lopinavir/Ritonavir 600mg/150mg (2 cycles)Experimental Treatment1 Intervention
Cohort 3 will receive two 5-day cycles of the highest dose of the suppository (Lopinavir/Ritonavir (600mg/150mg)) in Weeks 0 and 2, if the Cohort 2 dose is safe.
Group III: Cohort 2b: Lopinavir/Ritonavir 400mg/100mg (3 cycles)Experimental Treatment1 Intervention
Cohort 2b will receive three 5-day cycle of the higher dose of the suppository (Lopinavir/Ritonavir (400mg/100mg)) in Weeks 0, 2 and 4 if Cohort 3 has one DLT.
Group IV: Cohort 2: Lopinavir/Ritonavir 400mg/100mg (2 cycles)Experimental Treatment1 Intervention
Cohort 2 will receive two 5-day cycles of the higher dose of the suppository (Lopinavir/Ritonavir (400mg/100mg)) in Weeks 0 and 2, if Cohort 1 dose is safe.
Group V: Cohort 1b: Lopinavir/Ritonavir 200mg/50mg (3 cycles)Experimental Treatment1 Intervention
Cohort 1b will receive three 5-day cycles of the low dose of the suppository (Lopinavir/Ritonavir (200mg/50mg)) in Weeks 0, 2, and 4 if Cohort 2 has one dose-limiting toxicity (DLT).
Group VI: Cohort 1: Lopinavir/Ritonavir 200mg/50mg (2 cycles)Experimental Treatment1 Intervention
Cohort 1 will receive two 5-day cycles of the low dose of the suppository (Lopinavir/Ritonavir (200mg/50mg)) in Weeks 0 and 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritonavir
FDA approved
Find a Location
Who is running the clinical trial?
Wisconsin Partnership ProgramOTHER
7 Previous Clinical Trials
437 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,525 Total Patients Enrolled
Evie Carchman, MD, FACSPrincipal InvestigatorUniversity of Wisconsin, Madison
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need to take medication that cannot be combined with lopinavir/ritonavir.I am unable to understand and give consent for treatment.I am 18 years old or older.I am currently undergoing chemotherapy or radiation for another cancer.I have been diagnosed with low-grade anal dysplasia.I have been diagnosed with high-grade anal intraepithelial neoplasia.I have been treated with creams or ointments for anal precancer.I have tested positive for HPV.My cholesterol and triglyceride levels are outside the normal range.I am HIV-positive, my CD4 count is over 200, and my HIV is under control with medication.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: Lopinavir/Ritonavir 200mg/50mg (2 cycles)
- Group 2: Cohort 1b: Lopinavir/Ritonavir 200mg/50mg (3 cycles)
- Group 3: Cohort 2: Lopinavir/Ritonavir 400mg/100mg (2 cycles)
- Group 4: Cohort 2b: Lopinavir/Ritonavir 400mg/100mg (3 cycles)
- Group 5: Cohort 3: Lopinavir/Ritonavir 600mg/150mg (2 cycles)
- Group 6: Cohort 4: Lopinavir/Ritonavir 600mg/150mg (3 cycles)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the FDA's opinion on Lopinavir / Ritonavir?
"Lopinavir / Ritonavir is still in Phase 1 of clinical trials, so there is limited evidence to support its efficacy and safety. Our team at Power gave it a score of 1."
Answered by AI
Are patients currently being accepted into this trial?
"Unfortunately, this study is not presently looking for candidates. As referenced on clinicaltrials.gov, the last update to this posting was on April 11th, 2022. Although this particular trial may not be enrolling patients at the moment, there are 2532 other clinical trials with open recruitment at present."
Answered by AI
What goals does this research aim to achieve?
"The objective of this study, as measured over the course of 5 weeks, is to establish the Maximum Tolerated Dose (MTD) via observing the number of participants who experience dose-limiting toxicity (DLT) at each dosage level. Additionally, secondary measures such as the efficacy of lopinavir/ritonavir administration in regards to AIN2/3 regression determined by pathology and anal cytology will be recorded. The mechanism of action for protease inhibitors will also be investigated through biomarker studies involving immunohistochemistry and immunofluorescence techniques on tissue samples."
Answered by AI
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