MeaslesNCT02058927
Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia
An observational study of Measles, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
Trial 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. Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: HIV-1 infected children initiating ART in public clinics within Lusaka, Zambia.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Reconstitution to Measles Virus of HIV-1-Infected Zambian Children Initiating Antiretroviral Therapy
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.
Read the 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
- Measles
- Being tested
- Measles vaccine
- Keywords
- HIV, ART, children
- Medical subject headings
- Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measles vaccineDrug
measles revaccination administered at 12 months from start of ART
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Measles vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 6, 12, 24, 30 and 36 months from start of ART
Secondary outcomes (1)
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.
Measured: 12, 15, 24, 30 and 36 months from start of ART
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startMay 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for MeaslesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Bolton Moore, MD, University of North Carolina, Chapel Hill
- Investigators
- Carolyn B Moore, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058927
- Sponsor's protocol ID
- CIDRZ 1204/IRB12-0400
- Other IDs
- R01AI070018
- Status last verified
- Sep 2014
- First submitted
- 6 Feb 2014
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15319741de 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.
PubMed 10889592Gortmaker SL, Hughes M, Cervia J, Brady M, Johnson GM, Seage GR 3rd, Song LY, Dankner WM, Oleske JM; Pediatric AIDS Clinical Trials Group Protocol 219 Team. Effect of combination therapy including protease inhibitors on mortality among children and adolescents infected with HIV-1. N Engl J Med. 2001 Nov 22;345(21):1522-8. doi: 10.1056/NEJMoa011157.
PubMed 11794218Autran B, Carcelain G, Li TS, Blanc C, Mathez D, Tubiana R, Katlama C, Debre P, Leibowitch J. Positive effects of combined antiretroviral therapy on CD4+ T cell homeostasis and function in advanced HIV disease. Science. 1997 Jul 4;277(5322):112-6. doi: 10.1126/science.277.5322.112.
PubMed 9204894Pakker NG, Notermans DW, de Boer RJ, Roos MT, de Wolf F, Hill A, Leonard JM, Danner SA, Miedema F, Schellekens PT. Biphasic kinetics of peripheral blood T cells after triple combination therapy in HIV-1 infection: a composite of redistribution and proliferation. Nat Med. 1998 Feb;4(2):208-14. doi: 10.1038/nm0298-208.
PubMed 9461195Gibb DM, Newberry A, Klein N, de Rossi A, Grosch-Woerner I, Babiker A. Immune repopulation after HAART in previously untreated HIV-1-infected children. Paediatric European Network for Treatment of AIDS (PENTA) Steering Committee. Lancet. 2000 Apr 15;355(9212):1331-2. doi: 10.1016/s0140-6736(00)02117-6.
PubMed 10776748Vigano A, Vella S, Saresella M, Vanzulli A, Bricalli D, Di Fabio S, Ferrante P, Andreotti M, Pirillo M, Dally LG, Clerici M, Principi N. Early immune reconstitution after potent antiretroviral therapy in HIV-infected children correlates with the increase in thymus volume. AIDS. 2000 Feb 18;14(3):251-61. doi: 10.1097/00002030-200002180-00007.
PubMed 10716501van Rossum AM, Scherpbier HJ, van Lochem EG, Pakker NG, Slieker WA, Wolthers KC, Roos MT, Kuijpers JH, Hooijkaas H, Hartwig NG, Geelen SP, Wolfs TF, Lange JM, Miedema F, de Groot R; Dutch Study Group for Children with HIV Infections. Therapeutic immune reconstitution in HIV-1-infected children is independent of their age and pretreatment immune status. AIDS. 2001 Nov 23;15(17):2267-75. doi: 10.1097/00002030-200111230-00008.
PubMed 11698700Douek DC, Koup RA, McFarland RD, Sullivan JL, Luzuriaga K. Effect of HIV on thymic function before and after antiretroviral therapy in children. J Infect Dis. 2000 Apr;181(4):1479-82. doi: 10.1086/315398. Epub 2000 Apr 13.
PubMed 10762580Chavan S, Bennuri B, Kharbanda M, Chandrasekaran A, Bakshi S, Pahwa S. Evaluation of T cell receptor gene rearrangement excision circles after antiretroviral therapy in children infected with human immunodeficiency virus. J Infect Dis. 2001 May 15;183(10):1445-54. doi: 10.1086/320197. Epub 2001 Apr 13.
PubMed 11329124Johnston AM, Valentine ME, Ottinger J, Baydo R, Gryszowka V, Vavro C, Weinhold K, St Clair M, McKinney RE. Immune reconstitution in human immunodeficiency virus-infected children receiving highly active antiretroviral therapy: a cohort study. Pediatr Infect Dis J. 2001 Oct;20(10):941-6. doi: 10.1097/00006454-200110000-00006.
PubMed 11642627De Rossi A, Walker AS, Klein N, De Forni D, King D, Gibb DM. Increased thymic output after initiation of antiretroviral therapy in human immunodeficiency virus type 1-infected children in the Paediatric European Network for Treatment of AIDS (PENTA) 5 Trial. J Infect Dis. 2002 Aug 1;186(3):312-20. doi: 10.1086/341657. Epub 2002 Jul 5.
PubMed 12134227Resino S, Correa R, Bellon JM, Sanchez-Ramon S, Munoz-Fernandez MA. Characterizing immune reconstitution after long-term highly active antiretroviral therapy in pediatric AIDS. AIDS Res Hum Retroviruses. 2002 Dec 10;18(18):1395-406. doi: 10.1089/088922202320935474.
PubMed 12487811Burgess K, Price P, James IR, Stone SF, Keane NM, Lim AY, Warmington JR, French MA. Interferon-gamma responses to Candida recover slowly or remain low in immunodeficient HIV patients responding to ART. J Clin Immunol. 2006 Mar;26(2):160-7. doi: 10.1007/s10875-006-9008-4. Epub 2006 Mar 28.
PubMed 16568352Hainaut M, Ducarme M, Schandene L, Peltier CA, Marissens D, Zissis G, Mascart F, Levy J. Age-related immune reconstitution during highly active antiretroviral therapy in human immunodeficiency virus type 1-infected children. Pediatr Infect Dis J. 2003 Jan;22(1):62-9. doi: 10.1097/00006454-200301000-00016.
PubMed 12544411
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Reconstitution to Measles Virus of HIV-1-Infected Zambian Children Initiating Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT02058927
- Acronym / sponsor ID
- CIDRZ 1204/IRB12-0400
- Conditions
- Measles
- Keywords
- HIV, ART, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- May 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: Measles vaccinenested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers |
Who may qualify
- Ages
- 9 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- HIV-1 infected children initiating ART in public clinics within Lusaka, Zambia.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measles vaccinemeasles revaccination administered at 12 months from start of ART | Drug | HIV-1 infected children revaccinated |
Primary outcome
Memory immune responses to measles virus
Time frame: 0, 6, 12, 24, 30 and 36 months from start of ART
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.
1 secondary outcome
Humoral and cellular immune responses to measles virus before and after revaccination
Time frame: 12, 15, 24, 30 and 36 months from start of ART
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
- Background: PubMed 15319741Newell 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.
- Background: PubMed 10889592de 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.
- Background: PubMed 11794218Gortmaker SL, Hughes M, Cervia J, Brady M, Johnson GM, Seage GR 3rd, Song LY, Dankner WM, Oleske JM; Pediatric AIDS Clinical Trials Group Protocol 219 Team. Effect of combination therapy including protease inhibitors on mortality among children and adolescents infected with HIV-1. N Engl J Med. 2001 Nov 22;345(21):1522-8. doi: 10.1056/NEJMoa011157.
- Background: PubMed 9204894Autran B, Carcelain G, Li TS, Blanc C, Mathez D, Tubiana R, Katlama C, Debre P, Leibowitch J. Positive effects of combined antiretroviral therapy on CD4+ T cell homeostasis and function in advanced HIV disease. Science. 1997 Jul 4;277(5322):112-6. doi: 10.1126/science.277.5322.112.
- Background: PubMed 9461195Pakker NG, Notermans DW, de Boer RJ, Roos MT, de Wolf F, Hill A, Leonard JM, Danner SA, Miedema F, Schellekens PT. Biphasic kinetics of peripheral blood T cells after triple combination therapy in HIV-1 infection: a composite of redistribution and proliferation. Nat Med. 1998 Feb;4(2):208-14. doi: 10.1038/nm0298-208.
- Background: PubMed 10776748Gibb DM, Newberry A, Klein N, de Rossi A, Grosch-Woerner I, Babiker A. Immune repopulation after HAART in previously untreated HIV-1-infected children. Paediatric European Network for Treatment of AIDS (PENTA) Steering Committee. Lancet. 2000 Apr 15;355(9212):1331-2. doi: 10.1016/s0140-6736(00)02117-6.
- Background: PubMed 10716501Vigano A, Vella S, Saresella M, Vanzulli A, Bricalli D, Di Fabio S, Ferrante P, Andreotti M, Pirillo M, Dally LG, Clerici M, Principi N. Early immune reconstitution after potent antiretroviral therapy in HIV-infected children correlates with the increase in thymus volume. AIDS. 2000 Feb 18;14(3):251-61. doi: 10.1097/00002030-200002180-00007.
- Background: PubMed 11698700van Rossum AM, Scherpbier HJ, van Lochem EG, Pakker NG, Slieker WA, Wolthers KC, Roos MT, Kuijpers JH, Hooijkaas H, Hartwig NG, Geelen SP, Wolfs TF, Lange JM, Miedema F, de Groot R; Dutch Study Group for Children with HIV Infections. Therapeutic immune reconstitution in HIV-1-infected children is independent of their age and pretreatment immune status. AIDS. 2001 Nov 23;15(17):2267-75. doi: 10.1097/00002030-200111230-00008.
- Background: PubMed 10762580Douek DC, Koup RA, McFarland RD, Sullivan JL, Luzuriaga K. Effect of HIV on thymic function before and after antiretroviral therapy in children. J Infect Dis. 2000 Apr;181(4):1479-82. doi: 10.1086/315398. Epub 2000 Apr 13.
- Background: PubMed 11329124Chavan S, Bennuri B, Kharbanda M, Chandrasekaran A, Bakshi S, Pahwa S. Evaluation of T cell receptor gene rearrangement excision circles after antiretroviral therapy in children infected with human immunodeficiency virus. J Infect Dis. 2001 May 15;183(10):1445-54. doi: 10.1086/320197. Epub 2001 Apr 13.
- Background: PubMed 11642627Johnston AM, Valentine ME, Ottinger J, Baydo R, Gryszowka V, Vavro C, Weinhold K, St Clair M, McKinney RE. Immune reconstitution in human immunodeficiency virus-infected children receiving highly active antiretroviral therapy: a cohort study. Pediatr Infect Dis J. 2001 Oct;20(10):941-6. doi: 10.1097/00006454-200110000-00006.
- Background: PubMed 12134227De Rossi A, Walker AS, Klein N, De Forni D, King D, Gibb DM. Increased thymic output after initiation of antiretroviral therapy in human immunodeficiency virus type 1-infected children in the Paediatric European Network for Treatment of AIDS (PENTA) 5 Trial. J Infect Dis. 2002 Aug 1;186(3):312-20. doi: 10.1086/341657. Epub 2002 Jul 5.
- University of North Carolina websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn B Moore, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Measles, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory immune responses to measles virus (time frame: 0, 6, 12, 24, 30 and 36 months from start of ART). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02058927, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.