An Extension of Protocol PRO 140_CD01 Study

NCT02355184 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO 140_CD 01-Extension
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an extension of Protocol PRO 140\_CD 01 to further evaluate the long-term suppression of HIV-1 replication following substitution of stable combination antiretroviral therapy with a PRO 140 (Monoclonal CCR5 antibody) monotherapy in adult subjects with HIV-1 infection

Conditions

HIV; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Time to Virologic Failure After Initiating PRO 140 Monotherapy

  Virologic failure (VF) is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. The time to VF will be compared to a historical data (i.e., time to HIV-1 RNA viral load \> 500 copies/mL of 29 days). The statistical comparison will be conducted using Wilcoxon rank sum test and the median time to Virologic Failure for this study will be compared to 30 days.

  From treatment extension visit 1 (TE1) until virologic failure, assessed up to 125 weeks.

Secondary Outcomes (4)

• Proportion of Participants With Virologic Failure After Initiating PRO 140 Monotherapy.

  From treatment extension visit 1 (TE1) until virologic failure, assessed up to 125 weeks.

• Mean Change in Viral Load (HIV-1 RNA Levels)

  From treatment extension visit TE2 (defined as baseline), until week 58 of extension treatment.

• Mean Change in CD4 Cell Count

  From treatment extension visit TE2 (defined as baseline), until week 58 of extension treatment.

• Change in Quality of Life Metrics (up to TE107)

  From TE4 (baseline) through every fourth weekly visits to treatment visit 107 (TE107) or EOT, up to 125 weeks.

Other Outcomes (3)

• Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants(Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions.

  From TE1 (first treatment administration) weekly until last treatment visit (up to 125 weeks)

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

  From the first treatment visit (TE1) until final study visit, up to a 125 weeks.

• Number of Participants With at Least One Treatment-related Serious Adverse Event.

  From the first treatment visit (TE1) until final study visit up to 125 weeks.

Study Arms (1)

PRO 140

EXPERIMENTAL

PRO 140 350mg weekly subcutaneous (SC) injection.

Drug: PRO 140 350mg weekly subcutaneous (SC) injection.

Interventions

PRO 140 350mg weekly subcutaneous (SC) injection. DRUG

CCR5 Antagonist

Also known as: PRO 140

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 12 weeks of treatment in PRO 140\_CD01 study without experiencing virologic failure.
• Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (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 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\_CD01 Treatment Substitution Study
• Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
• Laboratory test values ≥ grade 4 DAIDS laboratory abnormality.
• Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
• Unexplained temperature \>38.5C (101.3F) for seven consecutive days within 14 days prior to the first study dose
• Diagnosed with either substance dependence or substance abuse or any history of a concomitant condition (e.g., medical, psychologic, or psychiatric) that in the opinion of the primary care provider and/or site investigator would interfere with the subject's successful completion of the study requirements
• 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)

CD01-Extension Investigational Site

San Francisco, California, 94115, United States

Location

Related Publications (1)

• Chang XL, Reed JS, Webb GM, Wu HL, Le J, Bateman KB, Greene JM, Pessoa C, Waytashek C, Weber WC, Hwang J, Fischer M, Moats C, Shiel O, Bochart RM, Crank H, Siess D, Giobbi T, Torgerson J, Agnor R, Gao L, Dhody K, Lalezari JP, Bandar IS, Carnate AM, Pang AS, Corley MJ, Kelly S, Pourhassan N, Smedley J, Bimber BN, Hansen SG, Ndhlovu LC, Sacha JB. Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species. PLoS Pathog. 2022 Mar 31;18(3):e1010396. doi: 10.1371/journal.ppat.1010396. eCollection 2022 Mar.

  PMID: 35358290 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

leronlimab; Injections

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

Certain lab data were not collected or were otherwise unavailable for analysis or reporting.

Results Point of Contact

• Title: Joseph Meidling
• Organization: CytoDyn

jmeidling@cytodyn.com

(360) 980-8524

Study Officials

• Jacob Lalezari, MD

  CytoDyn, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: January 30, 2015
• First Posted: February 4, 2015
• Study Start: November 18, 2014
• Primary Completion: June 1, 2022
• Study Completion: July 15, 2022
• Last Updated: October 7, 2025
• Results First Posted: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)