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

Phase 1
Completed
Conditions
HIV Infection
Registration Number
NCT02960581
Lead Sponsor
International AIDS Vaccine Initiative
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Pharmacokinetics: elimination half-life (t1/2)6 Months post infusion

Pharmacokinetics: elimination half-life (t1/2)

Pharmacokinetics: Clearance (CL/F)6 Months post infusion

Pharmacokinetics: Clearance (CL/F)

Pharmacokinetics: Volume of distribution (Vz/F)6 months post infusion

Pharmacokinetics: Volume of distribution (Vz/F)

Pharmacokinetics: Area under the concentration decay curve (AUC)6 months post infusion

Pharmacokinetics: Area under the concentration decay curve (AUC)

Proportion of participants with PGT121 mAb reactogenicity, related AEs and SAEs6 Months post infusion

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.

Pharmacokinetics: Impact of viral load and/or ART on PGT121 disposition, volume of distribution, total exposure6 months post infusion

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

Antiviral Activity6 Months post infusion

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center

🇺🇸

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States

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