An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study

NCT02990858 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO 140 _CD02 Extension
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

PRO 140\_CD02 Extension study seeks to evaluate the long-term efficacy, safety and tolerability of PRO 140 weekly injection in combination with Optimized Background Therapy (OBT) in patients infected with Human Immunodeficiency virus (HIV-1).

Conditions

Human Immunodeficiency Virus (HIV)

Keywords

HIV; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Mean Change in Viral Load (HIV-1 RNA Levels) at the Conclusion of Treatment Period

  The change from baseline in HIV-1 RNA levels (log 10 copies/mL) was summarized at least once every four weeks during the treatment extension phase. The time-weighted mean of change of the post baseline values was calculated. The time-weighted mean was adjusted AUC (area under the curve) by time.

  From TE1 (first treatment administration) to once every four weeks until last treatment visit (up to 56 months).

Secondary Outcomes (6)

• Mean Change in CD4 Cell Count at the Conclusion of Treatment Period

  From first treatment administration to each weekly visit until the last treatment visit (up to 56 months)

• Proportion of Participants Experiencing Emergence of Dual/Mixed (D/M)- and CXCR4-tropic Virus in Patients Who Had Exclusive CCR5-tropic Virus at Study Entry.

  From TE1 (first treatment administration) to last treatment visit, up to 56 months.

• Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Investigator Evaluation of Injection Site Reactions (ISR)

  From TE1 (first treatment administration) weekly until last treatment visit (up to 56 months).

• Number of Participants With Treatment-related Adverse Events Resulting in Study Drug Discontinuation

  From TE1 (first treatment administration) to last treatment visit, up to 56 months.

• Number of Participants With Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale

  From TE1 (first treatment administration) to last treatment visit, up to 56 months.

Study Arms (1)

Leronlimab (PRO 140)

EXPERIMENTAL

The treatment extension phase consists of weekly treatment injection of PRO 140 in addition to Optimized Background Therapy.

Drug: PRO 140

Interventions

PRO 140 DRUG

PRO 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5). Participants received 350 or 700 mg weekly injections of PRO 140.

Also known as: Leronlimab

Leronlimab (PRO 140)

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 24 weeks of treatment in PRO 140\_CD 02 or CD02\_OpenLabel study, and Investigator believes subject requires continued access to PRO 140 in order to continue deriving clinical benefit and maintain HIV-1 viral suppression.
• HIV-1 RNA ≤ 50 copies/ml at T23 Visit in PRO140\_CD02 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 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 subcutaneous (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 PRO 140\_CD 02 or CD02\_OpenLabel 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
• Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety measures

Sponsors & Collaborators

• CytoDyn, Inc.: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

leronlimab

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

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

36009808524

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 13, 2016
• Study Start: November 3, 2016
• Primary Completion: June 1, 2022
• Study Completion: July 10, 2022
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share