PRO 140 in Treatment-Experienced HIV-1 Subjects

August 27, 2025 updated by: CytoDyn, Inc.

A Multi-center, Two-Part, Single-Arm, Open Label, 25-Week Trial With PRO 140 in Treatment-Experienced HIV-1 Subjects

The primary objectives of the trial are to assess the efficacy, clinical safety and tolerability parameters of PRO 140 in combination with failing ART (antiretroviral therapy) during the initial one-week treatment period, and in combination with Optimized Background Therapy during the subsequent 24-week treatment period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRO 140, in combination with other antiretroviral agents, is indicated for treatment experienced adult HIV-1 patients infected with CCR5-tropic virus (virus that uses the chemokine receptor type 5 to enter the cell). These patients must demonstrate evidence of HIV-1 replication despite ongoing antiretroviral therapy and have documented genotypic or phenotypic resistance to at least one ART drug within three drug classes (or within two or more drug classes with limited treatment option). The options may be limited as a result of drug antiviral class cross-resistance, documented treatment intolerance, documented objective assessments such as renal or hepatic insufficiency (e.g. high creatinine at baseline, limiting treatment options due to potential for toxicity), past adverse reactions such as hypersensitivity reactions or neuropsychiatric issues that could limit use of currently approved drugs. Study population includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes (or within two drug classes with limited treatment option). The primary objectives of the trial are to assess the efficacy, clinical safety and tolerability parameters of PRO 140 in combination with failing ART during the initial one-week treatment period, and in combination with Optimized Background Therapy during the subsequent 24-week treatment period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palm Springs, California, United States, 92262
        • CD02_OpenLabel Investigational Site
      • San Francisco, California, United States, 94115
        • CD02_OpenLabel Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • CD02_OpenLabel Investigational Site
    • Florida
      • Ft. Pierce, Florida, United States, 34982
        • CD02_OpenLabel Investigational Site
      • Miami, Florida, United States, 33136
        • CD02_OpenLabel Investigational Site
      • Miami, Florida, United States, 33139
        • CD02_OpenLabel Investigational Site
      • Miami, Florida, United States, 33169
        • CD02_OpenLabel Investigational Site
      • Orlando, Florida, United States, 32803
        • CD02_OpenLabel Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • CD02_OpenLabel Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30033
        • CD02_OpenLabel Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60613
        • CD02_OpenLabel Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • CD02_OpenLabel Investigational Site
    • New York
      • Syracuse, New York, United States, 13210
        • CD02_OpenLabel Investigational Site
    • Texas
      • Bellaire, Texas, United States, 77301
        • CD02_OpenLabel Investigational Site
      • Houston, Texas, United States, 77004
        • CD02_OpenLabel Investigational Site
      • Houston, Texas, United States, 77098
        • CD02_OpenLabel Investigational Site
    • Washington
      • Spokane, Washington, United States, 99202
        • CD02_OpenLabel Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males and females, age ≥18 years
  2. Exclusive CCR5-tropic virus at Screening Visit as determined by Monogram Biosciences Trofile® Assay
  3. Have a history of at least 3 months on current antiretroviral regimen
  4. Treatment-experienced HIV-infected patients with documented genotypic or phenotypic resistance to at least one ART drug within three drug classes OR Treatment-experienced HIV-infected patients with documented genotypic or phenotypic resistance to at least one ART drug within two drug classes and have limited treatment option. The options may be limited as a result of drug antiviral class cross-resistance, documented treatment intolerance, documented objective assessments such as renal or hepatic insufficiency (e.g. high creatinine at baseline, limiting treatment options due to potential for toxicity), past adverse reactions such as hypersensitivity reactions or neuropsychiatric issues that could limit use of currently approved drugs.
  5. Be willing to remain on treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure
  6. Plasma HIV-1 RNA ≥ 400 copies/mL at Screening Visit as determined by Human Immunodeficiency Virus 1 (HIV-1) Quantitative, RNA (Roche Taqman® Real-Time PCR) and documented detectable viral load (HIV-1 RNA >50 copies/ml) within the last 3 months prior to Screening Visit

  7. Laboratory values at Screening of:

    1. Absolute neutrophil count (ANC) ≥750/mm3
    2. Hemoglobin (Hb) ≥10.5 gm/dL (male) or ≥ 9.5 gm/dL (female)
    3. Platelets ≥75,000 /mm3
    4. Serum alanine transaminase (SGPT/ALT) <5 x upper limit of normal (ULN)
    5. Serum aspartate transaminase (SGOT/AST) <5 x ULN
    6. Bilirubin (total) <2.5 x ULN unless Gilbert's disease is present or subject is receiving atazanavir in the absence of other evidence of significant liver disease
    7. Creatinine ≤1.5 x ULN
  8. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator
  9. 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
  10. 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 Note: Subjects diagnosed with either substance dependence or substance abuse or any history of a concomitant condition (e.g., medical, psychologic, or psychiatric) may be enrolled if in the opinion of site investigator these circumstances would not interfere with the subject's successful completion of the study requirements

Exclusion Criteria:

  1. Documented CXCR4-tropic virus or Dual/Mixed tropic (R5X4) virus as determined by HIV-1 tropism assay
  2. Patients with no viable treatment options ( i.e., no fully active antiretroviral drug available which can be effectively combined to form a viable new OBT)
  3. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma) Note: Subjects infected by the hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation and meet the liver function tests eligibility criteria
  4. Laboratory test values of ≥ grade 3 DAIDS (Division of Acquired Immune Deficiency Syndrome) laboratory abnormality with the exception of the absolute CD4+ count criterion of <200/mm3
  5. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  6. Unexplained fever or clinically significant illness within 1 week prior to the first study dose
  7. Any vaccination within 2 weeks prior to the first study dose
  8. Subjects weighing < 35kg
  9. History of anaphylaxis to oral or parenteral drugs
  10. History of Bleeding Disorder or patients on anti-coagulant therapy
  11. Participation in an experimental drug trial(s) within 30 days of the Screening Visit
  12. Any known allergy or antibodies to the study drug or excipients

  13. Treatment with any of the following:

    1. Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit
    2. Immunosuppressants within 60 days prior to the screening visit
    3. Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days prior to the screening visit

    4. Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy >5 mg/day will be excluded with the following exception:

      • Subjects on inhaled, nasal, or topical steroids will not be excluded
  14. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Leronlimab (PRO 140)
Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly subcutaneous (SC) Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy.
Drug: PRO 140
2 injections of PRO 140 (2 X 2 mL/inj.) Subjects who were previously enrolled and receiving 350 mg dose had the option to move to the 700mg dose for the remainder of the trial.
Other Names:
  • Leronlimab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the Initial 1-week Treatment Period
Time Frame: 1-week from baseline to the end of the initial PRO 140 and ART treatment period
The primary endpoint for this study is the proportion of participants with a ≥ 0.5 log10 reduction in HIV-1 RNA viral load from baseline to the end of the initial 1-week treatment period.
1-week from baseline to the end of the initial PRO 140 and ART treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants With ≥ 1 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the Initial 1-week Treatment Period
Time Frame: 1-week from baseline to the end of the initial PRO 140 and ART treatment period
The secondary endpoint is the proportion of participants with ≥ 1 log10 reduction in HIV-1 RNA viral load from baseline at the end of the initial 1-week treatment period
1-week from baseline to the end of the initial PRO 140 and ART treatment period
Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL) at the End of the Initial 1-week Treatment Period
Time Frame: 1-week from baseline to the end of the initial PRO 140 and ART treatment period

The secondary endpoint is the mean change between baseline and the end of the 1-week of treatment period in HIV-1 RNA levels (log10 copies/mL) (baseline was T1, mean change was calculated between time points T1 and T2).

If the mean change is a negative value, this indicates a reduction in viral load.
1-week from baseline to the end of the initial PRO 140 and ART treatment period
Percentage of Participants Achieving HIV-1 RNA < 400 Copies/mL at Week 25
Time Frame: 25 weeks post-initiation of PRO 140 and existing ART treatment
The secondary endpoint is the percentage of participants achieving HIV-1 RNA < 400 copies/mL at week 25
25 weeks post-initiation of PRO 140 and existing ART treatment
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 25
Time Frame: 25 weeks post-initiation of PRO 140 and existing ART treatment
The secondary outcome measure is the percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 25
25 weeks post-initiation of PRO 140 and existing ART treatment
Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL)
Time Frame: 25 weeks post-initiation of PRO 140 and existing ART treatment

The secondary outcome measure is the mean change in HIV-1 RNA levels (log10 copies/mL) between Baseline (T1) and week 25 (T25). Baseline was T1, mean change was calculated between time points T1 and T25.

If the mean change is a negative value, this indicates a reduction in viral load.
25 weeks post-initiation of PRO 140 and existing ART treatment
Mean Change From Baseline in CD4 Cell Count at the End of the Initial 1-week Treatment Period
Time Frame: 1-week post-initiation of PRO 140 and ART treatment.
The secondary outcome measure is the mean change in CD4 cell count between Baseline and the end of the initial 1-week treatment period (T2). Baseline was T1, mean change was calculated between time points T1 and T2.
1-week post-initiation of PRO 140 and ART treatment.
Mean Change From Baseline in CD4 Cell Count at Week 23
Time Frame: 23 weeks post-initiation of PRO 140 and existing ART treatment
The secondary outcome measure is the mean change in CD4 cell count between Baseline (T1) and week 23 (T23)
23 weeks post-initiation of PRO 140 and existing ART treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CytoDyn, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Amarex Clinical Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Scott Kelly, MD, CytoDyn, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO 140_CD02_OpenLabel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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