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

• Grade 3 or 4 sign/symptom, laboratory abnormality, or death that may be related to the vaccine
  
• 2 consecutive viral loads of 400 copies/ml or more while receiving HAART
  
• 2 consecutive absolute CD4 cell counts of 250 cells/mm3 or more while receiving HAART
  
• 2 consecutive CD4 cell counts more than 50% below the baseline CD4 cell count
  

• Tolerability (receipt of the full schedule of 4 vaccines)
  
• viral load setpoint: average of the log10 viral load measures at Weeks 18, 20, and 22 after HAART withdrawl (study Weeks 48, 50, and 52)
  
• Positive vaccine-elicited ELISPOT response as defined by a twofold increase from baseline that is also 100 or more spots/1,000,000 PBMCs
  
• Positive vaccine-elicited intracellular cytokine staining response as defined by a twofold increase from baseline AND 300 or more spots/1,000,000 PBMCs
  

Highly active antiretroviral therapy (HAART) has greatly improved mortality and morbidity rates associated with HIV and AIDS. However, many HIV-1 infected individuals are unable to access HAART. It is therefore important to develop a safe and effective therapeutic vaccine to improve immune control of viral replication and reduce the need for antiretroviral medication. This study will evaluate the safety and immunogenicity of the HIV-1 DNA vaccine VRC-HIVDNA009-00-VP in treating HIV-1 infected individuals who initiated antiretroviral therapy during acute infection. This study will involve a supervised treatment interruption (STI) in order to determine whether therapeutic vaccination results in improved immune control of viral replication.

Participants in this study will be randomly assigned to receive either the therapeutic vaccine or placebo in addition to their regular HAART regimens. During the first part of the study, participants will receive 4 vaccinations at Weeks 0, 4, 8 and 24. All individuals completing the therapeutic vaccination phase (defined as completing at least 3 immunizations, including the Week 24 immunization) will be given the opportunity to participate in the second part of the study and undergo a supervised discontinuation of HAART. At Week 30, these participants will discontinue all antiretroviral treatment and will be closely monitored. Participants will restart HAART if they experience a significant decline in their CD4 count, an increase in their viral loads, or if their physicians recommend they resume HAART. At Week 52, all other participants can restart HAART at the discretion of their primary physician.

21 study visits will occur over a period of 52 weeks. After Week 52, monthly study visits will occur through Week 72. Study visits will last approximately two hours and will include physical exams and blood and urine collection.