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AzTrials

HIVPhase 2NCT02175680

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

A Phase 2 study testing PRO 140 and Historical data in people with HIV and Human Immunodeficiency Virus, run by CytoDyn, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, Human Immunodeficiency Virus
What is being tested?
PRO 140 and Historical data
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteUnited States
Study dates
16 Apr 2014to 2 Feb 2015
Phase
Phase 2
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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Quest Clinical Research

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: A Phase 2b Study to Assess 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

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.

Read the detailed description

This study is a Phase 2b, multi-center study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in patients who are stable on combination antiretroviral therapy.

Patient enrollment will be staggered in this study to facilitate adequate safety monitoring. A lead cohort will include 12 subjects. Enrollment of additional 28 subjects will not be initiated until it is approved by the independent Data Monitoring Committee (DMC).

Consenting patients will be shifted from combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be up to 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do not experience Virologic Failure.

PRO 140 will be administered as a 350 mg subcutaneous injection weekly for up to 14 weeks. Study participants will be monitored for viral rebound on a weekly basis following initiation of PRO 140 monotherapy and will re-initiate their previous antiretroviral regimen if plasma HIV-1 RNA levels rise above 400 copies/ml on two consecutive blood draws at least 3 days apart.

The study will have three phases: Screening Phase, Treatment Phase and Follow-up Phase.

The primary objective is to assess efficacy of PRO 140 monotherapy for the maintenance of viral suppression following substitution of antiretroviral therapy in patients who are stable on combination antiretroviral therapy.

The secondary objective of the trial is to assess the clinical safety and tolerability parameters following substitution of antiretroviral therapy in patients who are stable on combination antiretroviral therapy.

Being tested
PRO 140, Historical data
Keywords
HIV-1, HIV, Treatment Substitution, PRO 140, PRO140, CytoDyn, Amarex
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 PRO 140 350mg

    CCR5 Antagonist

  • Historical dataOther

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

Study groups in NCT02175680
Study groupRoleWhat they receive
PRO 140ExperimentalPRO 140 350mg weekly SQ injection.
Receives: Drug: PRO 140; Other: Historical data

What is being measured

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

  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.

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

Secondary outcomes (7)

  1. Proportion of Subjects With Virologic Failure

    Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14.

    Measured: From initiation of PRO 140 monotherapy through week 14

  2. Mean Change From Baseline in Viral Load

    Mean change in Viral Load (HIV-1 RNA levels - log 10 copies/ml)), at each visit within the 14-week treatment phase.

    Measured: From initiation of PRO 140 monotherapy through week 14

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

    Mean Change from Baseline in viral load at the last virologic failure visit from Week 1 to Week 14. VF can occur at any time during the treatment phase from week 1 to week 14. Subjects who experience Virologic Failure will be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to <50 copies/mL)

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

  4. Mean Change in CD4 Cell Count by Visit

    Mean change in CD4 cell count, at each visit within the 14-week treatment phase

    Measured: From baseline (week 2) through week 14

  5. Mean Change in CD4 Cell Count

    Change from baseline in CD4 cell count, within the 14-week treatment phase

    Measured: From baseline (week 2) to last visit

  6. Q1 QOL Health Status

    Quality of Life Q1 Current General Health Status, is collected from base line to virologic failure (VF can occur at any time from any time during the treatment phase from week 1 to week 14). Subjects who experience Virologic Failure will be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to <50 copies/mL)

    Measured: From baseline to virologic failure (VF occurring at any time from Week 1 to Week 12 or virologic failure which ever comes first)

  7. Q2 QOL Current State of Health

    Subjects will rate their current state of health via Visual Analog Scale (VAS) using the line as a guide, with 0 as death or worst possible health and 100 as perfect or best possible health. A higher score indicates best outcome. Subjects may experience Virologic Failure (VF) any time during the treatment phase from week 1 to week 14. Subjects who experience VF will be followed up every 4 weeks until the viral load suppression is achieved (i.e., plasma HIV-1 RNA levels to return back to <50 copies/mL)

    Measured: From week 1 through treatment weeks 4, 8, 12 or VF visit

Timeline

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

  1. First posted26 Jun 2014 (estimated)
  2. Study start16 Apr 2014
  3. Primary completion2 Feb 2015
  4. Study completion2 Feb 2015

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
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
NCT02175680
Sponsor's protocol ID
PRO 140_CD 01
Status last verified
Mar 2023
First submitted
24 Jun 2014
Last updated
14 Apr 2023
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35358290

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PRO 140 and Historical data in people with HIV and Human Immunodeficiency Virus, run by CytoDyn, Inc. at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 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.

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 14 Apr 2023). 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?

Time to Virologic Failure After Initiating PRO 140 Monotherapy. (time frame: From initiation of PRO 140 monotherapy through week 14 or virological failure). 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 NCT02175680, which also lists 1 linked publication.

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 14 Apr 2023.

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