Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs (NCT00257127) | Clinical Trial Compass
CompletedNot Applicable
Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs
United States101 participantsStarted 2006-02
Plain-language 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, patients in this study will receive booster shots of one of two pneumococcal vaccines, a hepatitis B vaccine, and a measles vaccine.
Who can participate
Age range6 Years – 23 Years
SexALL
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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 rela…
What they're measuring
1
Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol
Timeframe: At study entry
Trial details
NCT IDNCT00257127
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)