An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study

This study is a Phase 2b/3 multi-center extension study designed to evaluate the long term antiviral activity, safety, and tolerability of the strategy of continuing PRO 140 350mg, 525mg, or 700mg SC monotherapy to maintain viral suppression after initial 48 weeks in virologically suppressed subjects.

Consenting subjects will continue weekly PRO 140 350mg, 525mg, or 700mg monotherapy during the Treatment Extension Phase with the one week overlap of existing retroviral regimen and PRO 140 350mg, 525mg, or 700 mg at the end of the treatment in subjects who do not experience virologic failure.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: PRO 140 350; Drug: PRO 140 525; Drug: PRO 140 700

Detailed Description

The objective is to assess the long-term safety of using PRO 140 350mg, 525mg, or 700mg SC as single-agent maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Quest Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects who have completed 48 weeks of treatment in PRO140_CD03 study.
2. Last known Plasma HIV-1 RNA < 50 copies/mL within PRO140_CD03 study.
3. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
4. Willing and able to participate in all aspects of the study, including use of SC medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.

Exclusion Criteria:

1. Not currently enrolled in PRO140_CD03 study.
2. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma).
3. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
4. Subjects weighing < 35kg.
5. History of anaphylaxis to any oral or parenteral drugs.

6. History of Bleeding Disorder or patients on anti-coagulant therapy (except aspirin).

   Note: Subjects with well-controlled bleeding disorder while on stable anti-coagulant therapy dose with documented stable INRs can be enrolled as per discretion of the Investigator.

7. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRO 140 350 mg; PRO 140 350mg weekly SQ injection.	Drug: PRO 140 350; Pro140 SC injection 350 mg
Experimental: PRO 140 525 mg; PRO 140 525mg weekly SQ injection.	Drug: PRO 140 525; 525 mg
Experimental: PRO 140 700 mg; PRO 140 700mg weekly SQ injection.	Drug: PRO 140 700; 700 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Long term clinical safety of PRO 140 350mg, 525, or 700 mg monotherapy regimen will be measured based on participants With Treatment-Related Adverse Events	200 weeks
Proportion of participants experiencing virologic failure, defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL for all subjects and within each treatment group will be measured	200 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to virologic failure, defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL for all subjects and within each treatment group will be measured	200 weeks
Proportion of participants achieving viral re-suppression (HIV-1 RNA < 50 copies/mL) after experiencing virologic failure for all subjects and within each treatment group will be measured	200 weeks
Time to achieving viral re-suppression (HIV-1 RNA < 50 copies/mL) after experiencing virologic failure for all subjects and within each treatment group will be measured	200 weeks
Proportion of virologic failure subjects achieving viral re-suppression (HIV-1 RNA < 50 copies/mL) with re-initiation of previous baseline antiretroviral regimen for all subjects and within each treatment group will be measured	200 weeks
Mean change in CD4 cell count, at each visit within the Treatment Phase for all subjects will and within each treatment group will be measured	200 weeks

Collaborators and Investigators

• Sponsor: CytoDyn, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2017
• Primary Completion (Anticipated): December 20, 2022
• Study Completion (Anticipated): April 10, 2023

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Immunologic Factors; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Leronlimab; HIV Antibodies
• Other Study ID Numbers: PRO 140_CD03 Extension

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No