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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI070018 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-1 infected children | HIV-1-infected children initiating ART | ||
| HIV-1 uninfected children | control group of HIV-1 uninfected children matched by age | ||
| HIV-1 infected children revaccinated | nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measles vaccine | Drug | measles revaccination administered at 12 months from start of ART |
|
| Measure | Description | Time Frame |
|---|---|---|
| Memory immune responses to measles virus | Memory immune responses to measles virus will be measured to characterize the magnitude and quality of immune reconstitution in HIV-1 infected Zambian children initiating ART and determine pathogen-specific immune reconstitution. | 0, 6, 12, 24, 30 and 36 months from start of ART |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral and cellular immune responses to measles virus before and after revaccination | Humoral and cellular immune responses to measles virus before and after revaccination of HIV-1-infected Zambian children receiving ART who lack protective antibody titers will be measured. | 12, 15, 24, 30 and 36 months from start of ART |
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Inclusion Criteria:
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HIV-1 infected children initiating ART in public clinics within Lusaka, Zambia.
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn B Moore, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Infectious Disease Research in Zambia | Lusaka | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15319741 | Background | Newell ML, Brahmbhatt H, Ghys PD. Child mortality and HIV infection in Africa: a review. AIDS. 2004 Jun;18 Suppl 2:S27-34. doi: 10.1097/00002030-200406002-00004. | |
| 10889592 | Background | de Martino M, Tovo PA, Balducci M, Galli L, Gabiano C, Rezza G, Pezzotti P. Reduction in mortality with availability of antiretroviral therapy for children with perinatal HIV-1 infection. Italian Register for HIV Infection in Children and the Italian National AIDS Registry. JAMA. 2000 Jul 12;284(2):190-7. doi: 10.1001/jama.284.2.190. |
| Label | URL |
|---|---|
| University of North Carolina website | View source |
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| ID | Term |
|---|---|
| D008457 | Measles |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D008458 | Measles Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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blood samples will be stored in a repository for five years beyond the end of the study period. Some samples may be exported to the Johns Hopkins Bloomberg School of Public Health when assays cannot be performed in Zambia.
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| D014777 | Virus Diseases |
| D007239 | Infections |