Status:
COMPLETED
Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
6-23 years
Phase:
NA
Brief Summary
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, patient...
Detailed Description
With their immunocompromised status, HIV-infected children are at especially high risk for opportunistic infections, including infection by Streptococcus pneumoniae, hepatitis B, and measles. In PACTG...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00257127
Start Date
February 1 2006
End Date
August 1 2006
Last Update
November 1 2021
Active Locations (26)
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1
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35233
2
Usc La Nichd Crs
Alhambra, California, United States, 91803
3
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90806
4
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States, 92103