Lopinavir/Ritonavir in PLWH With High-Grade AIN

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-19

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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This is a Phase I modified 3 + 3 design, in which the maximum tolerated dose (MTD) will be identified. The 3 + 3 dose escalation will consist of 6 dose levels (18 participants; planned escalation described in arms below) in combination with variation in dosing schedules of the drug lopinavir/ritonavir. This design also allows for some possible intermediate doses to be examined if dose-limiting toxicities (DLTs) occur and de-escalation is needed.

An expansion cohort of 12 participants will occur at the MTD. Once the MTD is determined, then secondary outcomes will be evaluated.

Primary Objective

* To evaluate the safety and tolerability of intra-anal administration of lopinavir/ritonavir, administered via suppository with 3 different schedules, in PLWH with high-grade anal intraepithelial neoplasia (HGAIN) (AIN 2/3).

Secondary Objectives

* To measure the effect of intra-anal topical lopinavir/ritonavir administration
* To evaluate clearance of human papillomavirus (HPV)
* To elucidate the mechanism of action of protease inhibitors

Conditions

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High-Grade Anal Intraepithelial Neoplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

modified 3+3 design with increasing concentrations of study drug and thorough assessment of potential toxicities.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Intervention Type DRUG

Human Immunodeficiency Virus (HIV) antiviral, given via suppository

Interventions

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Lopinavir / Ritonavir

Human Immunodeficiency Virus (HIV) antiviral, given via suppository

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* willing to provide informed consent
* greater than or equal to 18 years of age
* Diagnosis of biopsy-confirmed HGAIN
* Human immunodeficiency virus (HIV)-positive with CD4 count greater than 200 cells/mm\^3 at screening and virologically suppressed on HIV-1 antiretroviral therapy (ART) within last 12 months
* 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.
* Have received topical therapy for anal dysplasia previously

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No