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Immune Function of Infants With HIV

Primary Purpose

HIV Infections

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring AIDS, Vertical Transmission, Acute Infection

Eligibility Criteria

undefined - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Infants and children born to HIV infected women

Sites / Locations

  • University of Massachusetts Medical School

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 18, 2003
Last Updated
September 25, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00073229
Brief Title
Immune Function of Infants With HIV
Official Title
Killer Cells and Viral Load in Vertical HIV Infection
Study Type
Observational

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This observational study will evaluate data from infants born to HIV infected mothers in order to better characterize disease progression in early HIV infection.
Detailed Description
The role of HIV-specific cytotoxic T-lymphocytes (CTL) in controlling viremia and protecting against disease progression following vertical infection may be dependent upon CTL functional responses as well as on the timing of detection, magnitude, and breadth of the responses. Novel and sensitive assay systems (MHC-peptide tetramers, ELISPOT assays, intracellular cytokine assays) have enhanced the detection and characterization of virus-specific CTL responses in the peripheral blood. This study will use these novel methods to examine the timing of detection, magnitude, specificity, and in vitro functional properties of HIV-specific CTL in infants; to evaluate the effects of potent combination antiretroviral therapy on HIV-specific CTL in infants; and to evaluate the immunogenicity of recombinant pox-based vaccines in HIV infected infants with prolonged viral suppression following early potent combination antiretroviral therapy. Blood samples from infants born to HIV infected women will be obtained from infants enrolled in other HIV trials. Generally, samples will be obtained at birth, Week 1, and Months 1, 2, 4, 6, 9, and 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
AIDS, Vertical Transmission, Acute Infection

7. Study Design

Enrollment
80 (Anticipated)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants and children born to HIV infected women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Luzuriaga, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14764694
Citation
Gibson L, Piccinini G, Lilleri D, Revello MG, Wang Z, Markel S, Diamond DJ, Luzuriaga K. Human cytomegalovirus proteins pp65 and immediate early protein 1 are common targets for CD8+ T cell responses in children with congenital or postnatal human cytomegalovirus infection. J Immunol. 2004 Feb 15;172(4):2256-64. doi: 10.4049/jimmunol.172.4.2256.
Results Reference
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PubMed Identifier
15190139
Citation
Luzuriaga K, McManus M, Mofenson L, Britto P, Graham B, Sullivan JL; PACTG 356 Investigators. A trial of three antiretroviral regimens in HIV-1-infected children. N Engl J Med. 2004 Jun 10;350(24):2471-80. doi: 10.1056/NEJMoa032706.
Results Reference
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PubMed Identifier
15288824
Citation
Obaro SK, Pugatch D, Luzuriaga K. Immunogenicity and efficacy of childhood vaccines in HIV-1-infected children. Lancet Infect Dis. 2004 Aug;4(8):510-8. doi: 10.1016/S1473-3099(04)01106-5.
Results Reference
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PubMed Identifier
14722451
Citation
Safrit JT, Ruprecht R, Ferrantelli F, Xu W, Kitabwalla M, Van Rompay K, Marthas M, Haigwood N, Mascola JR, Luzuriaga K, Jones SA, Mathieson BJ, Newell ML; Ghent IAS Working Group on HIV in Women Children. Immunoprophylaxis to prevent mother-to-child transmission of HIV-1. J Acquir Immune Defic Syndr. 2004 Feb 1;35(2):169-77. doi: 10.1097/00126334-200402010-00012.
Results Reference
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PubMed Identifier
12759463
Citation
Scott ZA, Beaumier CM, Sharkey M, Stevenson M, Luzuriaga K. HIV-1 replication increases HIV-specific CD4+ T cell frequencies but limits proliferative capacity in chronically infected children. J Immunol. 2003 Jun 1;170(11):5786-92. doi: 10.4049/jimmunol.170.11.5786.
Results Reference
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PubMed Identifier
16272358
Citation
Sanchez-Merino V, Nie S, Luzuriaga K. HIV-1-specific CD8+ T cell responses and viral evolution in women and infants. J Immunol. 2005 Nov 15;175(10):6976-86. doi: 10.4049/jimmunol.175.10.6976.
Results Reference
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Immune Function of Infants With HIV

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