Lopinavir/Ritonavir in PLWH With High-Grade AIN

Conditions

• High-Grade Anal Intraepithelial Neoplasia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lopinavir / Ritonavir — DRUG
  Human Immunodeficiency Virus (HIV) antiviral, given via suppository

Study Details

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.

Key Dates

Start date

Dec 19, 2023

Status verified

May 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

21 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: Cohort 1: Lopinavir/Ritonavir 200mg/50mg (2 cycles)
  Cohort 1 will receive two 5-day cycles of the low dose of the suppository (Lopinavir/Ritonavir (200mg/50mg)) in Weeks 0 and 2
• Experimental: Cohort 1b: Lopinavir/Ritonavir 200mg/50mg (3 cycles)
  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).
• Experimental: Cohort 2: Lopinavir/Ritonavir 400mg/100mg (2 cycles)
  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.
• Experimental: Cohort 2b: Lopinavir/Ritonavir 400mg/100mg (3 cycles)
  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.
• Experimental: Cohort 3: Lopinavir/Ritonavir 600mg/150mg (2 cycles)
  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.
• Experimental: Cohort 4: Lopinavir/Ritonavir 600mg/150mg (3 cycles)
  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.

Primary Outcome Measure

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) [ Time Frame: up to 5 weeks ]

Central Contacts

• Cancer Connect, MD, FACS
  800-622-8922
  [email protected]

Locations (1)

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