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



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:5/27/2013
Start Date:March 2009
End Date:November 2016

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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.

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).
We found this trial at
37
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Baltimore, Maryland 21287
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Boston, MA
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Bronx, NY
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Bronx, New York 10461
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Chicago, Illinois 60614
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Chicago, IL
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Detroit, MI
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Durham, North Carolina 27710
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Durham, NC
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Houston, Texas 77030
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Long Beach, California 90806
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Los Angeles, California 90054
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Los Angeles, California 90033
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Memphis, Tennessee 38105
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New Orleans, Louisiana 70112
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New York, New York 10029
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New York, New York 10016
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New York, New York 10032
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Newark, NJ
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Newark, New Jersey 07103
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San Francisco,, California 94117
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Seattle, Washington 98105
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Seattle, Washington 98105
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Seattle, Washington 98105
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Stony Brook, New York 11794
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Washington, District of Columbia 20060
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Worcester, Massachusetts 01605
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