Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants

A single group of approximately 12 HIV-infected subjects will receive a 4 dose series of PENNVAX-B containing 3 mg of DNA/dose at study entry (Day 0), Week 4, 8, 16 and will be followed for a total of 48 weeks.

Inclusion criteria

• HIV-1 infection
• On a stable HAART regimen for ≥3 months before the time of enrollment
• CD4-+ lymphocyte count ≥400 cells/μL on two occasions within 60 days of enrollment
• HIV-1 < 75 copies/mL on two occasions within 60 days of enrollment
• Body mass index (BMI) ≤30 kg/m^2
• Laboratory values obtained within 30 days prior to study entry:

• Hemoglobin > 9 g/dL (female subjects) > 9.5 g/dL (male subjects)
• Absolute neutrophil count > 1000 cells/μL
• Platelet count > 75,000/μL
• ALT, AST and alkaline phosphatase < 2.5 x upper limit of normal range
• Total bilirubin < 2.5 x upper limit of the laboratory normal range
• Serum creatinine <1.5 mg/dL X upper limit of normal (ULN)
• Female subjects of reproductive potential must have a negative serum pregnancy test performed within 30 days of initiating the protocol-specified vaccination and a negative urine pregnancy test at Day 0 (enrollment)
• Ability and willingness of subject or legal guardian/representative to give written informed consent

Exclusion criteria

• Any active or past AIDS-defining illness with the exception of minimal (less than 10 lesions) cutaneous Kaposi's sarcoma
• History of a CD4+ T-cell count ≤200/μL
• Grade 2 or higher CPK laboratory result
• Use of any known immunomodulatory therapy within 4 weeks prior to study entry
• Any malignancy requiring systemic or local toxic chemotherapy. Local radiation will be allowed
• Pregnancy or breast-feeding
• Uncontrolled diabetes mellitus
• Major organ transplantation
• Active alcohol or substance abuse or psychiatric illness, which in the opinion of the investigator will interfere with adherence to study requirements
• Clinically significant neurological disorder occurring within 1 year prior to study entry
• Use of systemic corticosteroids for 4 weeks within 3 months prior to study entry
• Presence of any chronic disease that in the opinion of the investigator might affect subject safety
• History of previous vaccination with an HIV-1 vaccine except where documentation of placebo is available
• History of cardiac arrhythmia
• History or evidence of autoimmune disease
• Allergies to bupivacaine or similar anesthetic
• Metal implants at the site of injection
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness
• Any other conditions judged by the investigator that would limit the evaluation of a subject