Trials / Completed
CompletedNCT02058927
Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia
Immune Reconstitution to Measles Virus of HIV-1-Infected Zambian Children Initiating Antiretroviral Therapy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 203 (actual)
- Sponsor
- University of North Carolina, Chapel Hill · Academic / Other
- Sex
- All
- Age
- 9 Months – 10 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Measles vaccine | measles revaccination administered at 12 months from start of ART |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2012-02-01
- Completion
- 2012-02-01
- First posted
- 2014-02-10
- Last updated
- 2014-09-18
Locations
1 site across 1 country: Zambia
Source: ClinicalTrials.gov record NCT02058927. Inclusion in this directory is not an endorsement.