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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine immune system function following vaccination in HIV-infected children currently taking anti-HIV drugs. To test the effectiveness of prior vaccination, patients in this study will receive booster shots of one of two pneumococcal vaccines, a hepatitis B vaccine, and a measles vaccine.

Key facts

Study ID

NCT00257127

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

101

Starts

2006-02-01

Expected to finish

2006-08-01

Last updated by the study team

2021-11-01

Who can join

Age: 6 and older, up to 23. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UAB, Dept. of Ped., Div. of Infectious Diseases — Birmingham, Alabama, United States
• Usc La Nichd Crs — Alhambra, California, United States
• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• UCSD Mother-Child-Adolescent Program CRS — San Diego, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease — New Haven, Connecticut, United States
• South Florida CDTC Ft Lauderdale NICHD CRS — Fort Lauderdale, Florida, United States
• Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy — Gainesville, Florida, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease — Chicago, Illinois, United States
• Children's Hosp. — New Orleans, Louisiana, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• BMC, Div. of Ped Infectious Diseases — Boston, Massachusetts, United States
• WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
• Rutgers - New Jersey Medical School CRS — Newark, New Jersey, United States
• SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS — Brooklyn, New York, United States
• Nyu Ny Nichd Crs — New York, New York, United States
• Metropolitan Hosp. Ctr. — New York, New York, United States
• Harlem Hosp. Ctr. NY NICHD CRS — New York, New York, United States
• Strong Memorial Hospital Rochester NY NICHD CRS — Rochester, New York, United States
• SUNY Stony Brook NICHD CRS — Stony Brook, New York, United States
• Bronx-Lebanon Hosp. IMPAACT CRS — The Bronx, New York, United States
• St. Christopher's Hosp. for Children — Philadelphia, Pennsylvania, United States
• Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.