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

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).