A Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 10-1074

In preclinical studies carried out in humanized mice and non-human primates, 10-1074 alone or
in combination with other neutralizing antibodies led to protection from HIV or simian/human
immunodeficiency virus (SHIV) infection and also to sustained suppression of HIV plasma
viremia. The aims of this protocol are to evaluate the safety, tolerability and
pharmacokinetics profile of 10-1074 in both HIV-infected and HIV-uninfected individuals, and
its antiretroviral activity in HIV-infected individuals.

Inclusion Criteria:

Group 1 (HIV-infected)

- Males and females, age 18 to 65

- HIV-1 infection confirmed by two independent assays.

- Group (1A-1C): HIV-infected individuals off ART for at least 8 weeks with HIV-1 plasma
RNA levels < 100,000 copies/ml by standard assays, or on ART with HIV-1 plasma RNA
levels < 500 copies/ml. HIV-1 RNA levels should be measured on 2 occasions, at least 1
week apart and one measurement must be performed within 49 days prior to enrollment.

- Group (1D): HIV-infected individuals off ART for at least 8 weeks with HIV-1 plasma
RNA levels < 100,000 copies/ml by standard assays, measured on 2 occasions, at least 1
week apart. At least one measurement must be performed within 49 days prior to
enrollment.

- Current CD4 count > 300 cells/μl.

- If sexually active male or female, and participating in sexual activity that could
lead to pregnancy, agrees to use two effective methods of contraception from 10 days
prior to the 10-1074 infusion until the end of the study.

Group 2 (HIV-uninfected):

- Males and females, age 18 to 65.

- Amenable to HIV risk reduction counseling and agrees to maintain behavior consistent
with low risk of HIV exposure.

- If sexually active male or female, and participating in sexual activity that could
lead to pregnancy, agrees to use two effective methods of contraception throughout the
study period, as described for the HIV-infected groups above.

Exclusion Criteria:

Group 1 (HIV-infected):

- Have a history of AIDS-defining illness within 1 year prior to enrollment.

- History of systemic corticosteroids, immunosuppressive anti-cancer, or other
medications considered significant by the trial physician within the last 6 months.

- Any clinically significant acute or chronic medical condition other than HIV
infection, that in the opinion of the investigator would preclude participation.

- Chronic Hepatitis B or Hepatitis C infection.

- Laboratory abnormalities in the parameters listed below:

Absolute neutrophil count ≤ 1,000; Hemoglobin ≤10 gm/dL; Platelet count ≤100,000; ALT ≥ 2.0
x ULN; AST ≥ 2.0 x ULN; Total bilirubin ≥ 1.25 x ULN; Creatinine ≥ 1.1 x ULN; Coagulation
parameters (PT, PTT or INR) ≥ 1.25 x ULN.

- Pregnancy or lactation.

- Any vaccination within 14 days prior to 10-1074 administration.

- History of severe reaction to a vaccine or drug infusion or history of severe allergic
reactions.

- Participation in another clinical study of an investigational product currently or
within past 12 weeks, or expected participation during this study.

Group 2 (HIV-uninfected):

- Confirmed HIV-1 or HIV-2 infection.

- History of immunodeficiency or autoimmune disease; use of systemic corticosteroids,
immunosuppressive anti-cancer, or other medications considered significant by the
trial physician within the last 6 months.

- Any clinically significant acute or chronic medical condition (such as autoimmune
diseases) that in the opinion of the investigator would preclude participation.

- Within the 12 months prior to enrollment, the volunteer has a history of sexually
transmitted infection.

- Chronic Hepatitis B or Hepatitis C infection.

- Laboratory abnormalities in the parameters listed:

Absolute neutrophil count ≤ 1,500; Hemoglobin ≤ 12 gm/dL if female; ≤ 13.5 gm/dL if male;
Platelet count ≤ 140,000; Alanine transaminase (ALT) ≥ 1.25 x upper limit of normal (ULN);
aspartate transaminase (AST) ≥ 1.25 x ULN; Total bilirubin ≥ 1.25 x ULN; Creatinine ≥ 1.1 x
ULN; Coagulation parameters (prothrombin time - PT, partial thromboplastin time - PTT or
INR) ≥ 1.25 x ULN.

- Pregnancy or lactation.

- Any vaccination within 14 days prior to 10-1074 administration.

- Receipt of any experimental HIV vaccine in the past.

- History of severe reaction to a vaccine or drug infusion or history of severe allergic
reactions.

- Participation in another clinical study of an investigational product currently or
within past 12 weeks, or expected participation during this study.