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Long-Term Outcomes in HIV-Infected Infants, Children, and Adolescents

This study is currently recruiting participants.
Verified May 2012 by International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Disease (NIAID)
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01061164
First received: February 1, 2010
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  Purpose

This study will examine the long-term effects of HIV infection, highly active antiretroviral therapy (HAART), and experimental treatments on children who participated in PACTG 219C or select IMPAACT studies.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Surveillance Study of Long-Term Outcomes in HIV-Infected Infants, Children and Adolescents

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Primary Outcome Measures:
  • To identify possible long-term adverse outcomes of HIV infection and complications of antiretroviral therapy (ART) or experimental interventions other than ARTs in HIV-infected infants, children, and adolescents at IMPAACT sites in the United States [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: March 2009
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV-infected infants, children, and adolescents
Infants, children, and adolescents with HIV infection who have participated in PACTG 219C and/or select IMPAACT studies.

Detailed Description:

The use of HAART has been important in extending the lives of people with HIV infection. However, prolonged use of HAART may have long-term consequences. In addition, people participating in clinical trials using experimental therapies to treat HIV infection may experience negative health outcomes. The purpose of this study is to identify the long-term effects of HIV infection, HAART, and experimental treatments in infants, children, and adolescents.

This study will enroll children who participated in PACTG 219C or various IMPAACT studies. There will be no study visits specifically for this study. Researchers will review participants' medical records annually and collect information on illnesses, medications, CD4 cell count and viral load data, and body measurements.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will include participants in PACTG 219C or select IMPAACT treatment studies.

Criteria

Inclusion Criteria:

  • Past or current documentation of a confirmed diagnosis of HIV-1 infection defined as two separate peripheral blood specimens from different days, and each specimen must be positive. More information on this criterion can be found in the protocol.
  • HIV-infected infants, children, or adolescents who participated in PACTG 219C during 5/1/06-5/31/07 and are not currently participating in ongoing long-term follow-up (LTFU) studies (e.g., Pediatric HIV/AIDS Cohort Study Adolescent Master Protocol [PHACS AMP], LEGACY). Please refer to the IMPAACT website for the current list of studies or contact the protocol team (actg.teamp1074@fstrf.org).

OR

  • HIV-infected infants, children, and adolescents at domestic sites who have participated in or are currently participating in IMPAACT treatment studies (including studies that have rolled over from the PACTG into IMPAACT) designated by the IMPAACT Network Executive Committee (NEC) for subsequent LTFU in this study, and are not currently participating in ongoing LTFU studies. Please refer to the IMPAACT website for the current list of studies or contact the protocol team (actg.teamp1074@fstrf.org).
  • Parent or legally-accepted representative/guardian is able and willing to provide signed informed consent for minors (unless child has emancipated minor status)

Exclusion Criteria:

  • Current participation in other ongoing LTFU studies (e.g., PHACS AMP, LEGACY). Please refer to the IMPAACT website for the current list of studies or contact the protocol team (actg.teamp1074@fstrf.org).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061164

  Show 39 Study Locations
Sponsors and Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
National Institute of Allergy and Infectious Disease (NIAID)
Investigators
Study Chair: Myron J. Levin, MD University of Colorado at Denver Health Sciences Center
Study Chair: Paige L. Williams, PhD Harvard School of Public Health
  More Information

Publications:

Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01061164     History of Changes
Other Study ID Numbers: IMPAACT P1074, U01AI068632
Study First Received: February 1, 2010
Last Updated: May 4, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 17, 2012