An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study

This is an extension study, to provide continued access to PRO 140 to subjects who complete participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO 140 to form a viable regimen, in the opinion of the treating physician. The patient population for this trial are treatment-experienced HIV infected patients with CCR5-tropic virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of treatment in the PRO140_CD02 study.

Study Overview

• Status: Active, not recruiting
• Conditions: Hiv; Human Immunodeficiency Virus
• Intervention / Treatment: Drug: PRO 140 SC injections

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2; Phase 3

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: Potential subjects are required to meet all of the following criteria for enrollment into the study.

1. Subjects who have completed 24 weeks of treatment in PRO 140_CD 02 study, and Investigator believes subject requires continued access to PRO 140 in order to continue deriving clinical benefit and maintain HIV-1 viral suppression
2. HIV-1 RNA ≤ 50 copies/ml at T23 Visit in PRO140_CD02 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 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: Potential subjects meeting any of the following criteria will be excluded from enrollment.

1. Not currently enrolled in PRO 140_CD 02 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. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety measures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRO 140	Drug: PRO 140 SC injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change in viral load (HIV-1 RNA levels) at the conclusion of treatment period	through study completion, an average of 4 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change in CD4 cell count at the conclusion of treatment period	through study completion, an average of 4 year
Emergence of Dual/Mixed (D/M)- and CXCR4-tropic virus in patients who had exclusive CCR5- tropic virus at study entry.	through study completion, an average of 4 year
Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator evaluation of injection site reactions	through study completion, an average of 4 year
Frequency of treatment-related adverse events resulting in study drug discontinuation	through study completion, an average of 4 year
Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale	through study completion, an average of 4 year
Frequency of treatment-emergent serious adverse events	through study completion, an average of 4 year

Collaborators and Investigators

• Sponsor: CytoDyn, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2016
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Leronlimab
• Other Study ID Numbers: PRO 140 _CD02 Extension

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED