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Immune Function of Infants With HIV

NCT ID: NCT00073229

Last Updated: 2008-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-07-31

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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AIDS Vertical Transmission Acute Infection

Eligibility Criteria

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Inclusion Criteria

* Infants and children born to HIV infected women
Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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University of Massachusetts

Principal Investigators

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Katherine Luzuriaga, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 14764694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15190139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15288824 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14722451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12759463 (View on PubMed)

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.

Reference Type RESULT
PMID: 16272358 (View on PubMed)

Other Identifiers

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5R01AI032391-11

Identifier Type: NIH

Identifier Source: secondary_id

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5R01AI032391-14

Identifier Type: NIH

Identifier Source: secondary_id

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5R01AI032391-15

Identifier Type: NIH

Identifier Source: org_study_id

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