AzTrials
AzTrials

HIV InfectionPhase 1NCT02960581

Safety, PK and Antiviral Activity of PGT121 Monoclonal Antibody in HIV-uninfected and HIV-infected Adults

A Phase 1 study testing PGT121 3mg/kg IV, PGT121 10mg/kg IV and PGT121 30mg/kg IV in people with HIV Infection, run by International AIDS Vaccine Initiative 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 is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infection
What is being tested?
PGT121 3mg/kg IV, PGT121 10mg/kg IV and PGT121 30mg/kg IV
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited States
Study dates
Nov 2016to 8 Jul 2019
Phase
Phase 1
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Group 1 Inclusion Criteria:

  • HIV-uninfected males or females age 18-50 years old
  • Willing to maintain low risk behavior for HIV infection

Group 1 Exclusion Criteria:

  • confirmed HIV-infection, pregnancy or lactation, significant acute or chronic disease and clinically significant laboratory abnormalities

Group 2 Inclusion Criteria:

  • HIV-infected males or females age 18-65 years old
  • On a stable antiretroviral regimen with HIV-1 RNA plasma level <50 copies/ml, CD4 cell count greater than or equal to 300 cells/uL

Group 2 Exclusion Criteria:

  • history of AIDS-defining illness within the previous 5 years, significant acute or chronic medical condition other than HIV infection, and clinically significant laboratory abnormalities

Group 3 Inclusion Criteria:

  • HIV-infected males or females age 18-65
  • Not on antiretroviral therapy for > 6 months with detectable HIV-1 viral load between 100 and 100,000 copies/ml, CD4 cell count greater than or equal to 300 cells/uL

Group 3 Exclusion Criteria:

  • history of AIDS-defining illness within the previous 5 years, significant acute or chronic medical condition other than HIV infection, and clinically significant laboratory abnormalities

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Phase 1 Randomized Placebo-controlled Clinical Trial of the Safety, Pharmacokinetics and Antiviral Activity of PGT121 Monoclonal Antibody (mAb) in HIV-uninfected and HIV-infected Adults

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy.

Read the detailed description

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy. PGT121 mAb is a recombinant human IgG1 monoclonal antibody that targets a V3 glycan-dependent epitope region of the HIV envelope protein. PGT121 mAb was chosen for this study because it is potent, neutralizes a wide array of HIV viruses, and can prevent and treat simian-human immunodeficiency virus (SHIV) in rhesus monkeys.

Conditions
HIV Infection
Being tested
PGT121 3mg/kg IV, PGT121 10mg/kg IV, PGT121 30mg/kg IV, PGT121 3mg/kg SC, Placebo (0.9% Sodium Chloride Injection USP (Saline))
Medical subject headings
HIV Infections

What participants receive

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

  • PGT121 3mg/kg IVBiological

    3mg/kg administered by IV Infusion

  • PGT121 10mg/kg IVBiological

    10mg/kg administered by IV infusion

  • PGT121 30mg/kg IVBiological

    30mg/kg administered by IV infusion

  • PGT121 3mg/kg SCBiological

    3mg/kg administered by SC injection

    Placebo: None

  • Placebo (0.9% Sodium Chloride Injection USP (Saline))Biological

Study groups in NCT02960581
Study groupRoleWhat they receive
Group 1AExperimentalHIV-uninfected participants
Receives: Biological: PGT121 3mg/kg IV; Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Group 1BExperimentalHIV-uninfected participants
Receives: Biological: PGT121 10mg/kg IV; Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Group 1CExperimentalHIV-uninfected participants
Receives: Biological: PGT121 30mg/kg IV; Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Group 2AExperimentalHIV-infected on ART, (<50 cp/ml)
Receives: Biological: PGT121 3mg/kg IV; Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Group 2BExperimentalHIV-infected on ART, (<50 cp/ml)
Receives: Biological: PGT121 10mg/kg IV; Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Group 2CExperimentalHIV-infected on ART, (<50 cp/ml)
Receives: Biological: PGT121 30mg/kg IV; Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))
Group 3AExperimentalHIV-Infected off ART (VL 2x10^3 - 1x10^5 cp/ml)
Receives: Biological: PGT121 30mg/kg IV
Group 3BExperimentalHIV-Infected off ART (VL 1x10^2 - 2x10^3 cp/ml)
Receives: Biological: PGT121 30mg/kg IV
Arm 1DExperimentalHIV-uninfected participants
Receives: Biological: PGT121 3mg/kg SC; Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline))

What is being measured

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

  1. Proportion of participants with PGT121 mAb reactogenicity, related AEs and SAEs

    The investigators will measure the following endpoints to evaluate the safety and tolerability of PGT121 mAb in HIV-uninfected and HIV-infected adults:

    1. Proportion of participants with moderate or greater reactogenicity (e.g., solicited adverse events) for 3 days following IV infusion of PGT121 mAb.
    2. Proportion of participants with moderate or greater and/or PGT121 mAb-related unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, following IV infusion of PGT121 mAb for the first 56 days post administration of Investigational Product.
    3. Proportion of participants with PGT121 mAb-related serious adverse events (SAEs) throughout the study period.

    Measured: 6 Months post infusion

  2. Pharmacokinetics: elimination half-life (t1/2)

    Pharmacokinetics: elimination half-life (t1/2)

    Measured: 6 Months post infusion

  3. Pharmacokinetics: Clearance (CL/F)

    Pharmacokinetics: Clearance (CL/F)

    Measured: 6 Months post infusion

  4. Pharmacokinetics: Volume of distribution (Vz/F)

    Pharmacokinetics: Volume of distribution (Vz/F)

    Measured: 6 months post infusion

  5. Pharmacokinetics: Area under the concentration decay curve (AUC)

    Pharmacokinetics: Area under the concentration decay curve (AUC)

    Measured: 6 months post infusion

  6. Pharmacokinetics: Impact of viral load and/or ART on PGT121 disposition, volume of distribution, total exposure

    Pharmacokinetics: Impact of viral load and/or ART on PGT121 disposition, volume of distribution, total exposure

    Measured: 6 months post infusion

  7. Antiviral Activity

    Change in plasma HIV-1 RNA levels from baseline (mean of pre-entry and entry values)

    Measured: 6 Months post infusion

Timeline

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

  1. First posted9 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion8 Jul 2019
  4. Study completion8 Jul 2019

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02960581
Sponsor's protocol ID
IAVI T001
Status last verified
Sep 2019
First submitted
18 Oct 2016
Last updated
17 Sep 2019
Results posted
No

Publications

  • Stephenson KE, Julg B, Tan CS, Zash R, Walsh SR, Rolle CP, Monczor AN, Lupo S, Gelderblom HC, Ansel JL, Kanjilal DG, Maxfield LF, Nkolola J, Borducchi EN, Abbink P, Liu J, Peter L, Chandrashekar A, Nityanandam R, Lin Z, Setaro A, Sapiente J, Chen Z, Sunner L, Cassidy T, Bennett C, Sato A, Mayer B, Perelson AS, deCamp A, Priddy FH, Wagh K, Giorgi EE, Yates NL, Arduino RC, DeJesus E, Tomaras GD, Seaman MS, Korber B, Barouch DH. Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial. Nat Med. 2021 Oct;27(10):1718-1724. doi: 10.1038/s41591-021-01509-0. Epub 2021 Oct 7.

    PubMed 34621054

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PGT121 3mg/kg IV, PGT121 10mg/kg IV and PGT121 30mg/kg IV in people with HIV Infection, run by International AIDS Vaccine Initiative 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?

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 17 Sep 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of participants with PGT121 mAb reactogenicity, related AEs and SAEs (time frame: 6 Months post infusion). The study lists 7 primary outcomes in all. 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 NCT02960581, 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 17 Sep 2019.

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