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Human Immunodeficiency Virus (HIV)Phase 2/3NCT02990858

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

A Phase 2/3 study testing PRO 140 in people with Human Immunodeficiency Virus (HIV), run by CytoDyn, Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Human Immunodeficiency Virus (HIV)
What is being tested?
PRO 140
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
No sites listed yet
Study dates
3 Nov 2016to 10 Jul 2022
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the study.

  1. 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.
  2. HIV-1 RNA ≤ 50 copies/ml at T23 Visit in PRO140_CD02 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 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 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.

Exclusion Criteria: Potential subjects meeting any of the following criteria will be excluded from enrollment.

  1. Not currently enrolled in PRO 140_CD 02 or CD02_OpenLabel 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. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety measures

About this study

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).

Read the detailed description

This is an extension study, to provide continued access to PRO 140 to subjects who complete participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO 140 to form a viable regimen, in the opinion of the treating physician. The patient population for this trial are treatment-experienced HIV infected patients with C-C Chemokine Receptor Type 5 (CCR5)-tropic virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of treatment in the PRO140_CD02 or CD02_OpenLabel study.

Being tested
PRO 140
Keywords
HIV, Human Immunodeficiency Virus
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRO 140Drug

    Also called Leronlimab

    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.

Study groups in NCT02990858
Study groupRoleWhat they receive
Leronlimab (PRO 140)ExperimentalThe treatment extension phase consists of weekly treatment injection of PRO 140 in addition to Optimized Background Therapy.
Receives: Drug: PRO 140

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

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

    The change from baseline in CD4 cell count was summarized for each visit during the treatment 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.

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

  2. 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.

    All patients have exclusive C-C chemokine receptor type 5 (CCR5)-tropic virus at study entry. The proportion of patients with any tropism result of dual/mixed was summarized.

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

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

    At each visit during the treatment extension phase, an injection site reaction assessment was completed for the current and previous injection sites. To assess severity, subcutaneous (SC) injection related events were recorded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table).

    Grade 1 indicates a mild event Grade 2 indicates a moderate event Grade 3 indicates a severe event Grade 4 indicates a potentially life-threatening event Participants who had no symptoms of injection site reactions, "0" was assigned.

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

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

    Treatment-related adverse events are defined as events with an onset on or after the first treatment (TE1).

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

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

    The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines:

    • Grade 1 indicates a mild event
    • Grade 2 indicates a moderate event
    • Grade 3 indicates a severe event
    • Grade 4 indicates a potentially life-threatening event
    • Grade 5 indicates death (Note: This grade is not specifically listed on each page of the grading table).

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

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

    Treatment-related (as defined by the investigator) serious adverse events are defined as serious events with an onset on or after the first treatment.

    A serious adverse event is defined as any adverse event that:

    • Results in death
    • Is life threatening (the subject is at immediate risk of dying from the AE)
    • Requires subject hospitalization or prolongs existing hospitalization
    • Results in persistent or significant disability/incapacity
    • Is a congenital anomaly/birth defect Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2016 (estimated)
  2. Study start3 Nov 2016
  3. Primary completionJun 2022
  4. Study completion10 Jul 2022

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02990858
Sponsor's protocol ID
PRO 140 _CD02 Extension
Status last verified
Aug 2025
First submitted
17 Nov 2016
Last updated
12 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing PRO 140 in people with Human Immunodeficiency Virus (HIV), run by CytoDyn, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Viral Load (HIV-1 RNA Levels) at the Conclusion of Treatment Period (time frame: From TE1 (first treatment administration) to once every four weeks until last treatment visit (up to 56 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02990858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.

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