Safety of and Immune Response to a DNA HIV Vaccine (VRC-HIVDNA009-00-VP) in HIV Infected Individuals With Acute HIV Infection

Inclusion Criteria:

• Treated acute HIV-1 infection (initiated HAART during the acute retroviral syndrome AND were diagnosed by a positive HIV-1 viral load and a negative or indeterminate Western blot)
• Minimum of 6 months of HAART, defined as 2 or more antiretroviral drugs in combination
• At least three CD4 cell counts over 350 cells/mm3 for a period of 6 months prior to study entry
• Screening CD4 cell count over 350 cells/mm3 within 30 days prior to study entry
• HIV-1 RNA levels over 50 copies/ml for a period of 6 months prior to study entry
• Screening HIV-1 RNA level less than 50 copies/ml within 30 days prior to study entry
• Agrees to use acceptable methods of contraception

Exclusion Criteria:

• History of serious adverse reactions to vaccines
• History of CD4 cell count less than 250 cells/mm3, opportunistic infections, or AIDS-defining illnesses. Patients who have had one CD4 count less than 250 cells/mm3 or who have had CD4 counts less than 250 cells/mm3 for not more than 2 weeks during acute infection are not excluded.
• History of autoimmune disease, immunodeficiency, asthma, diabetes requiring insulin or oral hypoglycemics, thyroid disease, bleeding disorder, active malignancy, viral hepatitis, or asplenia
• Positive HBV, HCV, or syphilis test
• Suspected allergy or adverse reaction to any component of the study agent
• Changes in antiretroviral regimen within 6 months prior to entry due to virologic failure (not including toxicities)
• Previous participation in STIs
• Pregnancy or breast-feeding
• Live attenuated vaccines or investigational research agents within the 30 days prior to study entry
• Blood products within the 120 days prior to study entry
• Immunoglobulin within the 60 days prior to study entry
• Subunit or killed vaccines or allergy treatments with antigen injections within the 14 days prior to study entry
• Prior experimental HIV vaccines
• Certain immunosuppressive medications within the 6 months prior to study entry
• Current TB prophylaxis or therapy
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
• Serious illness requiring systemic treatment and/or hospitalization. An individual who has either completed therapy OR is clinically stable for at least 14 days prior to study entry is eligible.
• Anti-dsDNA antibody greater than the upper limit of normal