NCT00073229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

Enrollment Period

4.9 years

First QC Date

November 18, 2003

Last Update Submit

September 25, 2008

Conditions

Keywords

AIDSVertical TransmissionAcute Infection

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants and children born to HIV infected women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

Related Publications (6)

  • 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.

    PMID: 14764694BACKGROUND
  • 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.

    PMID: 15190139BACKGROUND
  • 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.

    PMID: 15288824BACKGROUND
  • 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.

    PMID: 14722451BACKGROUND
  • 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.

    PMID: 12759463BACKGROUND
  • 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.

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Katherine Luzuriaga, MD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 18, 2003

First Posted

November 19, 2003

Study Start

July 1, 2000

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

September 26, 2008

Record last verified: 2008-09

Locations