Lopinavir / Ritonavir for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UW Digestive Health Center Anoscopy Clinic, Madison, WI
Cancer+2 More
Lopinavir / Ritonavir - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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 study for up to 40 weeks.

Eligible Conditions

  • Cancer
  • High-Grade Anal Intraepithelial Neoplasia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: week 16, week 28, week 40

up to 5 weeks
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)
Rate of Grade 3 or above Toxicities in any Organ System in the Escalation Cohorts
Week 40
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
Number of Tissue Samples with evidence of HPV positivity measured by presence of p16
Number of Tissue Samples with evidence of apoptosis measured by presence of Activated Caspase 3
Number of Tissue Samples with evidence of autophagy measured by presence of LC3β and p62
Number of Tissue Samples with evidence of cellular proliferation measured by presence of Ki-67
Number of Tissue Samples with p53 expression

Trial Safety

Safety Progress

1 of 3

Side Effects for

Lopinavir / Ritonavir
50%Diarrhoea
50%Headache
40%Nausea
30%Abdominal Discomfort
20%Nasal Congestion
20%Vessel Puncture Site Pain
20%Pharyngitis
20%Vomiting
20%Gastroesophageal Reflux Disease
20%Skin Burning Sensation
10%Abdominal Distention
10%Dysgeusia
10%Menstrual Discomfort
10%Presyncope
10%Somnolence
0%Atrioventricular Block Second Degree
0%Cold Sweat
0%Decreased Appetite
0%Chalazion
0%Constipation
0%Dissociation
0%Dizziness
0%Dry Mouth
0%Skin Reaction
0%Vessel Puncture Site Phlebitis
0%Vessel Puncture Site Swelling
0%Bradycardia
0%Flatulence
0%Palpitations
0%Back Pain
This histogram enumerates side effects from a completed 2017 Phase 1 trial (NCT03070470) in the Lopinavir / Ritonavir ARM group. Side effects include: Diarrhoea with 50%, Headache with 50%, Nausea with 40%, Abdominal Discomfort with 30%, Nasal Congestion with 20%.

Trial Design

6 Treatment Groups

Cohort 3: Lopinavir/Ritonavir 400mg/100mg
1 of 6
Cohort 2: Lopinavir/Ritonavir 200mg/50mg
1 of 6
Cohort 5: Lopinavir/Ritonavir 600mg/150mg
1 of 6
Cohort 1: Lopinavir/Ritonavir 200mg/50mg
1 of 6
Cohort 4: Lopinavir/Ritonavir 400mg/100mg
1 of 6
Cohort 6: Lopinavir/Ritonavir 600mg/150mg
1 of 6
Experimental Treatment

30 Total Participants · 6 Treatment Groups

Primary Treatment: Lopinavir / Ritonavir · No Placebo Group · Phase 1

Cohort 3: Lopinavir/Ritonavir 400mg/100mg
Drug
Experimental Group · 1 Intervention: Lopinavir / Ritonavir · Intervention Types: Drug
Cohort 2: Lopinavir/Ritonavir 200mg/50mg
Drug
Experimental Group · 1 Intervention: Lopinavir / Ritonavir · Intervention Types: Drug
Cohort 5: Lopinavir/Ritonavir 600mg/150mg
Drug
Experimental Group · 1 Intervention: Lopinavir / Ritonavir · Intervention Types: Drug
Cohort 1: Lopinavir/Ritonavir 200mg/50mg
Drug
Experimental Group · 1 Intervention: Lopinavir / Ritonavir · Intervention Types: Drug
Cohort 4: Lopinavir/Ritonavir 400mg/100mg
Drug
Experimental Group · 1 Intervention: Lopinavir / Ritonavir · Intervention Types: Drug
Cohort 6: Lopinavir/Ritonavir 600mg/150mg
Drug
Experimental Group · 1 Intervention: Lopinavir / Ritonavir · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lopinavir / Ritonavir
2020
Completed Phase 2
~1480

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 16, week 28, week 40
Closest Location: UW Digestive Health Center Anoscopy Clinic · Madison, WI
Photo of madison 1Photo of madison 2Photo of madison 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Cancer
0 CompletedClinical Trials

Who is running the clinical trial?

Wisconsin Partnership ProgramOTHER
6 Previous Clinical Trials
357 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,052 Previous Clinical Trials
2,559,881 Total Patients Enrolled
Evie Carchman, MD, FACSPrincipal InvestigatorUniversity of Wisconsin, Madison

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18 years of age or older.
You have HIV and your CD4 count is greater than 200 cells/mm^3.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.