Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs

Inclusion Criteria:

• Completed the 96-week initial study period of PACTG P1024 and had enrolled into that study between June 1, 2001 and March 31, 2002
• Fulfilled PACTG P1024's definition of HAART (taking 3 or more antiretrovirals [ARVs] from at least 2 of the available therapeutic drug classes) during PACTG P1024's vaccination period (Weeks 0 to 24). Patients who were taking 3 nucleoside reverse transcriptase inhibitors during that period without a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor (PI) are not eligible for this study. Nontherapeutic boosting doses of ritonavir used in ritonavir-boosted PI regimens are not counted as separate ARVs.
• Stable ARV regimen in the 4 weeks prior to study entry
• No changes anticipated to current ARV regimen during this study
• Willing to complete all study vaccinations and evaluations
• Willing to use acceptable forms of contraception, if applicable
• Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

• Abnormal blood or chemistry values on most recent laboratory tests. More information on this criterion can be found in the protocol.
• Received PCV, HBV, PPV, or MMR vaccines during PACTG P1024 in a sequence other than specified in PACTG P1024
• Received one or more doses of each of PCV, PPV, MMR, or HBV vaccines since the end of PACTG P1024's vaccination period
• Previous Grade 3 or higher adverse events or allergic reactions judged to be possibly or definitely related to the PCV, PPV, MMR, or HBV vaccines
• Received any killed vaccine within the 4 weeks prior to study entry
• Received any live vaccine within the 6 weeks prior to study entry
• Planning to receive any killed or live vaccine other than study vaccines between the first and third study visits
• Presence of an underlying condition that contraindicates use of any of the study vaccines. Patients who have a CD4% less than 15% will not be given the MMR vaccine, but such patients will not be excluded from this study.
• Current immunomodulatory therapy, including IL-2, any interferon product, GM-CSF, or thalidomide. Patients taking G-CSF or erythropoietin are not excluded.
• Anticipated need for immunomodulatory treatment during this study
• Any intramuscular immune globulin product within the 6 months prior to study entry
• Intravenous immune globulin within the 11 months prior to study entry
• Platelets or plasma products within the 7 months prior to study entry
• Anticipated need for immune globulin products during this study
• Current systemic immunosuppressive therapy, including the equivalent of 1 mg/kg/day or greater of prednisone in the 2 weeks prior to study entry. Patients using inhaled corticosteroids only are not excluded from this study. More information on this criterion can be found in the protocol.
• Anticipated need for systemic immunosuppressive therapy during this study
• Other known or suspected diseases of the immune system
• Cancer in the 3 months prior to study entry or treatment for cancer within the 3 months prior to study entry
• Other acute or chronic medical or surgical conditions or contraindications that, in the opinion of the investigator, may interfere with the study
• Known bleeding disorder
• Any Grade 2 or higher clinical toxicity at study screening. More information on this criterion can be found in the protocol.
• Require certain medications
• Pregnancy