IMPAACT P1074: Long-Term Outcomes in HIV-Infected Infants, Children, and Adolescents

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT01061164

Run by

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

People needed

1207

Starts

2009-03-01

Expected to finish

2014-06-01

Last updated by the study team

2015-03-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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).

Where it is running

• Univ. of Alabama Birmingham NICHD CRS (5096) — Birmingham, Alabama, United States
• Miller Children's Hospital Long Beach (5093) — Long Beach, California, United States
• Usc La Nichd Crs (5048) — Los Angeles, California, United States
• Childrens Hospital Los Angeles (5090) — Los Angeles, California, United States
• UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601) — Los Angeles, California, United States
• UCSD Mother, Child & Adolescent HIV Program(4601) — San Diego, California, United States
• Univ. of California San Francisco NICHD CRS (5091) — San Francisco, California, United States
• University of Colorado Denver NICHD CRS (5052) — Aurora, Colorado, United States
• Children's National Med. Ctr. Washington DC NICHD CRS (5015) — Washington D.C., District of Columbia, United States
• Howard University Washington DC NICHD CRS (5044) — Washington D.C., District of Columbia, United States
• South Florida CDC Ft Lauderdale NICHD CRS (5055) — Fort Lauderdale, Florida, United States
• Univ. of Florida Jacksonville NICHD CRS (5051) — Jacksonville, Florida, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201) — Miami, Florida, United States
• University of South Florida Tampa (5018) — Tampa, Florida, United States
• Chicago Children's CRS (4001) — Chicago, Illinois, United States
• Tulane University (5095) — New Orleans, Louisiana, United States
• Johns Hopkins University NICHD CRS (5092) — Baltimore, Maryland, United States
• Children's Hospital of Boston NICHD CRS (5009) — Boston, Massachusetts, United States
• WNE Maternal Pediatric Adolescent AIDS CRS (7301) — Worcester, Massachusetts, United States
• Wayne State University/Children's Hospital of Michigan NICHD CRS (5041) — Detroit, Michigan, United States
• New Jersey Medical School (NJ) (2802) — Newark, New Jersey, United States
• Univ of Med & Dentistry of New Jersey/Univ Hosp — Newark, New Jersey, United States
• New York University NY (5012) — New York, New York, United States
• Metropolitan Hospital (5003) — New York, New York, United States
• Columbia IMPAACT Center (4101) — New York, New York, United States

Full record on ClinicalTrials.gov

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