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

International AIDS Vaccine Initiative

Status and phase: Completed; Phase 1

Conditions: HIV Infection

Treatments: Biological: PGT121 30mg/kg IV; Biological: PGT121 10mg/kg IV; Biological: PGT121 3mg/kg SC; Biological: Placebo (0.9% Sodium Chloride Injection USP (Saline)); Biological: PGT121 3mg/kg IV

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT02960581

IAVI T001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 9 patient groups

Group 1A

Experimental group

Description:

HIV-uninfected participants

Treatment:

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

Biological: PGT121 3mg/kg IV

Group 1B

Experimental group

Description:

HIV-uninfected participants

Treatment:

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

Biological: PGT121 10mg/kg IV

Group 1C

Experimental group

Description:

HIV-uninfected participants

Treatment:

Biological: PGT121 30mg/kg IV

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

Group 2A

Experimental group

Description:

HIV-infected on ART, (\<50 cp/ml)

Treatment:

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

Biological: PGT121 3mg/kg IV

Group 2B

Experimental group

Description:

HIV-infected on ART, (\<50 cp/ml)

Treatment:

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

Biological: PGT121 10mg/kg IV

Group 2C

Experimental group

Description:

HIV-infected on ART, (\<50 cp/ml)

Treatment:

Biological: PGT121 30mg/kg IV

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

Group 3A

Experimental group

Description:

HIV-Infected off ART (VL 2x10\^3 - 1x10\^5 cp/ml)

Treatment:

Biological: PGT121 30mg/kg IV

Group 3B

Experimental group

Description:

HIV-Infected off ART (VL 1x10\^2 - 2x10\^3 cp/ml)

Treatment:

Biological: PGT121 30mg/kg IV

Arm 1D

Experimental group

Description:

HIV-uninfected participants

Treatment:

Biological: PGT121 3mg/kg SC

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