A Clinical Trial of the Safety, Pharmacokinetics and Antiviral Activity of PGT121 Monoclonal Antibody (mAb) in HIV-uninfected and HIV-infected Adults
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ClinicalTrials.gov Identifier: NCT02960581 |
Recruitment Status :
Enrolling by invitation
First Posted : November 9, 2016
Last Update Posted : January 3, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Biological: PGT121 Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline)) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | November 2016 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Group 1
HIV-uninfected participants
|
Biological: PGT121
3mg/kg administered by IV Infusion Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline)) |
Experimental: Group 2
HIV-uninfected participants
|
Biological: PGT121
10mg/kg administered by IV infusion Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline)) |
Experimental: Group 3
HIV-uninfected participants
|
Biological: PGT121
30mg/kg administered by IV infusion Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline)) |
Experimental: Group 4
HIV-infected on ART, (<50 cp/ml)
|
Biological: PGT121
3mg/kg administered by IV Infusion Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline)) |
Experimental: Group 5
HIV-infected on ART, (<50 cp/ml)
|
Biological: PGT121
10mg/kg administered by IV infusion Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline)) |
Experimental: Group 6
HIV-infected on ART, (<50 cp/ml)
|
Biological: PGT121
30mg/kg administered by IV infusion Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline)) |
Experimental: Group 7
HIV-Infected off ART (VL 2x10^3 - 1x10^5 cp/ml)
|
Biological: PGT121
30mg/kg administered by IV infusion Placebo: None |
Experimental: Group 8
HIV-Infected off ART (VL 2x10^3 - 1x10^5 cp/ml)
|
Biological: PGT121
10mg/kg administered by IV infusion Placebo: None |
Experimental: Group 9
HIV-Infected off ART (VL 2x10^3 - 1x10^5 cp/ml)
|
Biological: PGT121
3mg/kg administered by IV infusion Placebo: None |
Experimental: Group 10
HIV-Infected off ART (VL 1x10^2 - 2x10^3 cp/ml)
|
Biological: PGT121
30mg/kg administered by IV infusion Placebo: None |
Experimental: Group 11
HIV-Infected off ART (VL 1x10^2 - 2x10^3 cp/ml)
|
Biological: PGT121
10mg/kg administered by IV infusion Placebo: None |
Experimental: Group 12
HIV-Infected off ART (VL 1x10^2 - 2x10^3 cp/ml)
|
Biological: PGT121
3mg/kg administered by IV infusion Placebo: None |
- Proportion of participants with PGT121 mAb related AEs and SAEs [ Time Frame: 6 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:
- Proportion of participants with moderate or greater reactogenicity (e.g., solicited adverse events) for 3 days following IV infusion of PGT121 mAb.
- 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.
- Proportion of participants with PGT121 mAb-related serious adverse events (SAEs) throughout the study period.
- Impact of viral load and/or ART on PGT121 disposition elimination half-life (t1/2) [ Time Frame: 6 Months post infusion ]
- Change in plasma HIV-1 RNA levels from baseline (mean of pre-entry and entry values) [ Time Frame: 6 Months post infusion ]
- Impact of viral load and/or ART on PGT121 disposition clearance (CL/F) [ Time Frame: 6 Months post infusion ]
- Impact of viral load and/or ART on PGT121 disposition volume of distribution (Vz/F) [ Time Frame: 6 months post infusion ]
- Impact of viral load and/or ART on PGT121 disposition total exposure [ Time Frame: 6 months post infusion ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Group 1 Inclusion Criteria:
- 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 on a stable antiretroviral regimen with HIV-1 RNA plasma level <50 copies/ml, CD4 cell count > 300 cells/uL and CD4 nadir > 200 cell/uL
Group 2 Exclusion Criteria:
- history of AIDS-defining illness, significant acute or chronic medical condition other than HIV infection, and clinically significant laboratory abnormalities
Group 3 Inclusion Criteria:
- HIV-infected males or females not on antiretroviral therapy for > 6 month with detectable HIV-1 RNA plasma level between 100 and 100,000 copies/ml, CD4 cell count > 300 cells/uL and CD4 nadir > 200 cell/uL
Group 3 Exclusion Criteria:
- history of AIDS-defining illness, significant acute or chronic medical condition other than HIV infection, and clinically significant laboratory abnormalities

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960581
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
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 |
Additional Information:
Responsible Party: | International AIDS Vaccine Initiative |
ClinicalTrials.gov Identifier: | NCT02960581 History of Changes |
Other Study ID Numbers: |
IAVI T001 |
First Posted: | November 9, 2016 Key Record Dates |
Last Update Posted: | January 3, 2019 |
Last Verified: | January 2019 |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Antibodies Antibodies, Monoclonal Antiviral Agents Immunologic Factors Physiological Effects of Drugs Anti-Infective Agents |