Safety, PK and Antiviral Activity of PGT121 Monoclonal Antibody in HIV-uninfected and HIV-infected Adults
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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2019
CompletedSeptember 17, 2019
September 1, 2019
2.7 years
October 18, 2016
September 13, 2019
Conditions
Outcome Measures
Primary Outcomes (7)
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.
6 Months post infusion
Pharmacokinetics: elimination half-life (t1/2)
Pharmacokinetics: elimination half-life (t1/2)
6 Months post infusion
Pharmacokinetics: Clearance (CL/F)
Pharmacokinetics: Clearance (CL/F)
6 Months post infusion
Pharmacokinetics: Volume of distribution (Vz/F)
Pharmacokinetics: Volume of distribution (Vz/F)
6 months post infusion
Pharmacokinetics: Area under the concentration decay curve (AUC)
Pharmacokinetics: Area under the concentration decay curve (AUC)
6 months post infusion
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
6 months post infusion
Antiviral Activity
Change in plasma HIV-1 RNA levels from baseline (mean of pre-entry and entry values)
6 Months post infusion
Study Arms (9)
Group 1A
EXPERIMENTALHIV-uninfected participants
Group 1B
EXPERIMENTALHIV-uninfected participants
Group 1C
EXPERIMENTALHIV-uninfected participants
Group 2A
EXPERIMENTALHIV-infected on ART, (\<50 cp/ml)
Group 2B
EXPERIMENTALHIV-infected on ART, (\<50 cp/ml)
Group 2C
EXPERIMENTALHIV-infected on ART, (\<50 cp/ml)
Group 3A
EXPERIMENTALHIV-Infected off ART (VL 2x10\^3 - 1x10\^5 cp/ml)
Group 3B
EXPERIMENTALHIV-Infected off ART (VL 1x10\^2 - 2x10\^3 cp/ml)
Arm 1D
EXPERIMENTALHIV-uninfected participants
Interventions
Eligibility Criteria
You may qualify if:
- HIV-uninfected males or females age 18-50 years old
- Willing to maintain low risk behavior for HIV infection
You may not qualify if:
- confirmed HIV-infection, pregnancy or lactation, significant acute or chronic disease and clinically significant laboratory abnormalities
- 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
- 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
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- International AIDS Vaccine Initiativelead
- Beth Israel Deaconess Medical Center, Boston MAcollaborator
- Ragon Institute of MGH, MIT and Harvard, Boston MAcollaborator
- University of Texas Health, Houston AIDS Research Team (HART), Houston TXcollaborator
- Mills Clinical Research, Los Angeles CAcollaborator
- Orlando Immunology Clinic, Orlando FLcollaborator
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
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.
PMID: 34621054DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn Stephenson, MD MPH
Beth Israel Deaconess Medical Center, Center for Virology and Vaccine Research
- STUDY CHAIR
Boris Juelg, MD PhD
Ragon Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2016
First Posted
November 9, 2016
Study Start
November 1, 2016
Primary Completion
July 8, 2019
Study Completion
July 8, 2019
Last Updated
September 17, 2019
Record last verified: 2019-09