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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01061164
First received: February 1, 2010
Last updated: December 12, 2013
Last verified: December 2013

February 1, 2010
December 12, 2013
March 2009
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01061164 on ClinicalTrials.gov Archive Site
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Long-Term Outcomes in HIV-Infected Infants, Children, and Adolescents
A Prospective Surveillance Study of Long-Term Outcomes in HIV-Infected Infants, Children and Adolescents

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

HIV Infections
Not Provided
HIV-infected infants, children, and adolescents
Infants, children, and adolescents with HIV infection who have participated in PACTG 219C and/or select IMPAACT studies.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1800
June 2016
June 2013   (final data collection date for primary outcome measure)

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).
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01061164
IMPAACT P1074, U01AI068632
Yes
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
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
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP