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

NCT05271370 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO 140_CD03 Extension
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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 (subcutaneous) 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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (2)

• Long Term Clinical Safety of PRO 140 Monotherapy by Assessing the Number of Participants With Grade 2, 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale, and the Number of Participants With Treatment-emergent Serious Adverse Events.

  The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines: * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death (Note: This grade is not specifically listed on each page of the grading table). Treatment-Emergent Serious Adverse Events (TESAEs) are defined as serious adverse events with an onset on or after the first treatment.

  From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

• Proportion of Participants Experiencing Virologic Failure for All Subjects Within Each Treatment Group.

  Virological failure is defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL for all subjects and within each treatment group.

  From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

Secondary Outcomes (5)

• Time to Virologic Failure After Initiating PRO 140 Monotherapy for All Subjects Within Each Treatment Group.

  From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

• Proportion of Participants Achieving Viral Re-suppression After Experiencing Virologic Failure Within Each Treatment Group.

  From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

• Time to Achieving Viral Re-suppression After Experiencing Virologic Failure Within Each Treatment Group.

  From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

• Proportion of Virologic Failure Subjects Achieving Viral Re-suppression With Re-initiation of Previous Baseline Antiretroviral Regimen Within Each Treatment Group.

  From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

• Mean Change in CD4 Cell Count, at Each Visit Within the Treatment Phase for All Subjects Within Each Treatment Group

  From TE1 (first treatment administration) to last treatment visit, up to 197 weeks

Study Arms (3)

PRO 140 350 mg

EXPERIMENTAL

PRO 140 350mg weekly SC injection.

Drug: PRO 140 350

PRO 140 525 mg

EXPERIMENTAL

PRO 140 525mg weekly SC injection.

Drug: PRO 140 525

PRO 140 700 mg

EXPERIMENTAL

PRO 140 700mg weekly SC injection.

Drug: PRO 140 700

Interventions

PRO 140 350 DRUG

Pro140 SC injection 350 mg

Also known as: leronlimab

PRO 140 350 mg

PRO 140 525 DRUG

525 mg

Also known as: leronlimab

PRO 140 525 mg

PRO 140 700 DRUG

700 mg

Also known as: leronlimab

PRO 140 700 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have completed 48 weeks of treatment in PRO140\_CD03 study.
• Last known Plasma HIV-1 RNA \< 50 copies/mL within PRO140\_CD03 study.
• 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.
• 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.

You may not qualify if:

• Not currently enrolled in PRO140\_CD03 study.
• Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma).
• Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
• Subjects weighing \< 35kg.
• History of anaphylaxis to any oral or parenteral drugs.
• 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.
• Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Sponsors & Collaborators

• CytoDyn, Inc.: lead

Study Sites (1)

Quest Clinical Research

San Francisco, California, 94115, United States

Location

MeSH Terms

Interventions

leronlimab

Limitations and Caveats

FDA required the sponsor to halt enrollment in the trial and transition participants to available therapies for the treatment of their disease. The trial was subsequently terminated once participants were transitioned.

Results Point of Contact

• Title: Vice President, Clinical Operations
• Organization: CytoDyn

jmeidling@cytodyn.com

3609808524

Study Officials

• Jacob Lalezari, MD

  CytoDyn, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: March 9, 2022
• Study Start: August 29, 2017
• Primary Completion: June 20, 2022
• Study Completion: July 10, 2022
• Last Updated: October 30, 2025
• Results First Posted: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)