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

NCT ID: NCT05271370

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-29
• Study Completion Date: 2022-07-10

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.

Detailed Description

The objective is to assess the long-term safety of using PRO 140 350mg, 525mg, or 700mg SC as single-agent maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection.

Conditions

HIV-1-infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRO 140 350 mg

PRO 140 350mg weekly SC injection.

Group Type: EXPERIMENTAL

PRO 140 350

Intervention Type: DRUG

Pro140 SC injection 350 mg

PRO 140 525 mg

PRO 140 525mg weekly SC injection.

Group Type: EXPERIMENTAL

PRO 140 525

Intervention Type: DRUG

525 mg

PRO 140 700 mg

PRO 140 700mg weekly SC injection.

Group Type: EXPERIMENTAL

PRO 140 700

Intervention Type: DRUG

700 mg

Interventions

PRO 140 350

Pro140 SC injection 350 mg

Intervention Type: DRUG

PRO 140 525

525 mg

Intervention Type: DRUG

PRO 140 700

700 mg

Intervention Type: DRUG

Other Intervention Names

leronlimab; leronlimab; leronlimab

Eligibility Criteria

Inclusion Criteria

1. Subjects who have completed 48 weeks of treatment in PRO140_CD03 study.

2. Last known Plasma HIV-1 RNA < 50 copies/mL within PRO140_CD03 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 serum pregnancy test at Screening visit and 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

1. Not currently enrolled in PRO140_CD03 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. Subjects weighing < 35kg.

5. History of anaphylaxis to any oral or parenteral drugs.

6. 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.

7. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CytoDyn, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob Lalezari, MD

Role: PRINCIPAL_INVESTIGATOR

CytoDyn, Inc.

Locations

Quest Clinical Research

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO 140_CD03 Extension

Identifier Type: -

Identifier Source: org_study_id