Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia
NCT ID: NCT02058927
Last Updated: 2014-09-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
203 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-05-31
Study Completion Date
2012-02-29
Brief Summary
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This is an observational study of HIV-1 infected children starting antiretroviral therapy to measure the magnitude and quality of general immune reconstitution and pathogen-specific immune reconstitution to measles virus.
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Detailed Description
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This is a prospective, observational cohort study of 230 HIV-1-infected children initiating ART at public clinics in Lusaka, Zambia to measure the magnitude and quality of general immune reconstitution and pathogen-specific immune reconstitution to measles virus. Non-specific immune reconstitution will be assessed by serial measurements of the number and percentages of CD4+ and CD8+ T-lymphocytes, number and percentages of activated CD4+ and CD8+ T-lymphocytes (using cell surface staining for HLA-DR and CD38), changes in the proportions of naïve and memory CD4+ and CD8+ T-lymphocyte subsets (using cell surface staining for CD45RA and CCR7), and changes in thymic output as determined by TREC levels. Virologic responses to ART will be assessed by serial measurements of plasma HIV-1 RNA levels.
Within the observational study, there is a nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers to assess the proportion of revaccinated children who develop protective immunity and the duration of protective immunity. Anti-measles virus IgG antibodies will be measured 9 months after initiation of ART. The results will be available at the 12-month follow-up visit and measles revaccination will be recommended to those children lacking protective antibody levels to measles virus.
Within the observational study, there is a nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers to assess the proportion of revaccinated children who develop protective immunity and the duration of protective immunity. Anti-measles virus IgG antibodies will be measured 9 months after initiation of ART. The results will be available at the 12-month follow-up visit and measles revaccination will be recommended to those children lacking protective antibody levels to measles virus.
Conditions
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Measles
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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HIV-1 infected children
HIV-1-infected children initiating ART
No interventions assigned to this group
HIV-1 uninfected children
control group of HIV-1 uninfected children matched by age
No interventions assigned to this group
HIV-1 infected children revaccinated
nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers
Measles vaccine
Intervention Type
DRUG
measles revaccination administered at 12 months from start of ART
Interventions
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Measles vaccine
measles revaccination administered at 12 months from start of ART
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Boys and girls 9 months to 10 years of age residing in Lusaka, Zambia are eligible for enrolment.
* initiating ART
* history of measles vaccination confirmed by examination of the Immunization Card.
* initiating ART
* history of measles vaccination confirmed by examination of the Immunization Card.
Minimum Eligible Age
9 Months
Maximum Eligible Age
10 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sponsor Role
collaborator
University of North Carolina, Chapel Hill
OTHER
Sponsor Role
lead
Responsible Party
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Carolyn Bolton Moore, MD
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Carolyn B Moore, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Centre for Infectious Disease Research in Zambia
Lusaka, , Zambia
Site Status
Countries
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Zambia
References
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Related Links
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http://www.unc.edu
University of North Carolina website
Other Identifiers
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CIDRZ 1204/IRB12-0400
Identifier Type: -
Identifier Source: org_study_id
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