Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection

NCT02175680 | Completed Phase 2 Results DMC

• 1 other identifier: PRO 140_CD 01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy. Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.

Conditions

HIV; Human Immunodeficiency Virus

Keywords

HIV-1; HIV; Treatment Substitution; PRO 140; PRO140; CytoDyn; Amarex

Outcome Measures

Primary Outcomes (1)

• Time to Virologic Failure After Initiating PRO 140 Monotherapy.

  Time to virologic failure after initiating PRO 140 monotherapy. Virologic failure was defined as two (2) consecutive HIV-1 RNA levels of ≥ 400 copies/mL.

  From initiation of PRO 140 monotherapy through week 14 or virological failure

Secondary Outcomes (7)

• Proportion of Subjects With Virologic Failure

  From initiation of PRO 140 monotherapy through week 14

• Mean Change From Baseline in Viral Load

  From initiation of PRO 140 monotherapy through week 14

• Change in Viral Load at the Last Virologic Failure Visit.

  From baseline to virologic failure visit (VF). VF can occur at any time from Week 1 to Week 14.

• Mean Change in CD4 Cell Count by Visit

  From baseline (week 2) through week 14

• Mean Change in CD4 Cell Count

  From baseline (week 2) to last visit

Other Outcomes (15)

• Injection Site Reaction - Pain (Site 1)

  From initiation of PRO 140 monotherapy through week 14

• Injection Site Reaction - Pain (Site 2)

  From initiation of PRO 140 monotherapy through week 14

• Injection Site Reaction - Injection Site Status (Site 1)

  From initiation of PRO 140 monotherapy through week 14

Study Arms (1)

PRO 140

EXPERIMENTAL

PRO 140 350mg weekly SQ injection.

Drug: PRO 140; Other: Historical data

Interventions

PRO 140 DRUG

CCR5 Antagonist

Also known as: PRO 140 350mg

PRO 140

Historical data OTHER

Historical data (i.e., time to HIV-1 RNA viral load \> 500 copies/mL of 29 days).

PRO 140

Eligibility Criteria

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

You may qualify if:

• Males and females, age ≥18 years
• Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile™ DNA Assay
• On stable antiretroviral therapy for last 12 months
• Subject has two or more potential alternative antiretroviral regimen options to consider.
• No documented detectable viral loads (HIV-1 RNA \<50 copies/ml) within the last 12 months prior to Screening Visit
• Nadir CD4 cell count of \>200 cells/mm3

You may not qualify if:

• CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay at the Screening Visit
• Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg)
• Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
• Prior use of any entry, attachment, CCR5 co-receptor, or fusion inhibitor, including PRO 140.
• 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
• Amarex Clinical Research: collaborator

Study Sites (1)

Quest Clinical Research

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

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

Results Point of Contact

• Title: Joseph Meidling, Sr. Director Clinical Operations
• Organization: CytoDyn Inc.

jmeidling@cytodyn.com

(360) 980-8524

Study Officials

• Jacob Lalezari, MD

  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: June 24, 2014
• First Posted: June 26, 2014
• Study Start: April 16, 2014
• Primary Completion: February 2, 2015
• Study Completion: February 2, 2015
• Last Updated: April 14, 2023
• Results First Posted: April 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)