A 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. 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.

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