Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Vaccination
Eligibility Criteria
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
Sites / Locations
- UAB, Dept. of Ped., Div. of Infectious Diseases
- Usc La Nichd Crs
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
- UCSD Mother-Child-Adolescent Program CRS
- Univ. of Colorado Denver NICHD CRS
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
- South Florida CDTC Ft Lauderdale NICHD CRS
- Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
- Univ. of Florida Jacksonville NICHD CRS
- Chicago Children's CRS
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
- Children's Hosp.
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- BMC, Div. of Ped Infectious Diseases
- WNE Maternal Pediatric Adolescent AIDS CRS
- Rutgers - New Jersey Medical School CRS
- Bronx-Lebanon Hosp. IMPAACT CRS
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
- Nyu Ny Nichd Crs
- Metropolitan Hosp. Ctr.
- Harlem Hosp. Ctr. NY NICHD CRS
- Strong Memorial Hospital Rochester NY NICHD CRS
- SUNY Stony Brook NICHD CRS
- St. Christopher's Hosp. for Children
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
- San Juan City Hosp. PR NICHD CRS
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2
Patients will receive PCV, HBV, and MMR at study entry
Patients will receive PPV, HBV, and MMR at study entry