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

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.