Clinical trial NCT02058927: Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia
Official title: Immune Reconstitution to Measles Virus of HIV-1-Infected Zambian Children Initiating Antiretroviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Measles
Keywords: HIV
ART
children
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2014-02-10
Enrollment: 203
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-1 infected children initiating ART in public clinics within Lusaka, Zambia.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Memory immune responses to measles virus
timeFrame: 0, 6, 12, 24, 30 and 36 months from start of ART
Secondary outcomes:
measure: Humoral and cellular immune responses to measles virus before and after revaccination
timeFrame: 12, 15, 24, 30 and 36 months from start of ART
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Centre for Infectious Disease Research in Zambia
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carolyn B Moore, MD
role: PRINCIPAL_INVESTIGATOR
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