Clinical trial NCT01061164: IMPAACT P1074: Long-Term Outcomes in HIV-Infected Infants, Children, and Adolescents
Official title: A Prospective Surveillance Study of Long-Term Outcomes in HIV-Infected Infants, Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2010-02-02
Enrollment: 1207
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include participants in PACTG 219C or select IMPAACT treatment studies.

Brief summary: 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.

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 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).

Primary outcomes:
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
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ. of Alabama Birmingham NICHD CRS (5096)
state: Alabama
city: Long Beach
country: United States
facility: Miller Children's Hospital Long Beach (5093)
state: California
city: Los Angeles
country: United States
facility: Usc La Nichd Crs (5048)
state: California
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles (5090)
state: California
city: Los Angeles
country: United States
facility: UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
state: California
city: San Diego
country: United States
facility: UCSD Mother, Child & Adolescent HIV Program(4601)
state: California
city: San Francisco
country: United States
facility: Univ. of California San Francisco NICHD CRS (5091)
state: California
city: Aurora
country: United States
facility: University of Colorado Denver NICHD CRS (5052)
state: Colorado
city: Washington
country: United States
facility: Children's National Med. Ctr. Washington DC NICHD CRS (5015)
state: District of Columbia
city: Washington
country: United States
facility: Howard University Washington DC NICHD CRS (5044)
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: South Florida CDC Ft Lauderdale NICHD CRS (5055)
state: Florida
city: Jacksonville
country: United States
facility: Univ. of Florida Jacksonville NICHD CRS (5051)
state: Florida
city: Miami
country: United States
facility: Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201)
state: Florida
city: Tampa
country: United States
facility: University of South Florida Tampa (5018)
state: Florida
city: Chicago
country: United States
facility: Chicago Children's CRS (4001)
state: Illinois
city: New Orleans
country: United States
facility: Tulane University (5095)
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University NICHD CRS (5092)
state: Maryland
city: Boston
country: United States
facility: Children's Hospital of Boston NICHD CRS (5009)
state: Massachusetts
city: Worcester
country: United States
facility: WNE Maternal Pediatric Adolescent AIDS CRS (7301)
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)
state: Michigan
city: Newark
country: United States
facility: New Jersey Medical School (NJ) (2802)
state: New Jersey
city: Newark
country: United States
facility: Univ of Med & Dentistry of New Jersey/Univ Hosp
state: New Jersey
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital IMPAACT CRS (6901)
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center Bronx (5013)
state: New York
city: New York
country: United States
facility: New York University NY (5012)
state: New York
city: New York
country: United States
facility: Metropolitan Hospital (5003)
state: New York
city: New York
country: United States
facility: Columbia IMPAACT Center (4101)
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital, University of Rochester NICHD CRS (5057)
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook (5040)
state: New York
city: Durham
country: United States
facility: Duke Pediatric Infectious Diseases
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center (DUMC) Pediatric CRS (4701)
state: North Carolina
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia IMPAACT CRS (6701)
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude/UTHSC CRS (6501)
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hosp. CRS (3801)
state: Texas
city: Seattle
country: United States
facility: Harborview Medical Center NICHD CRS (5027)
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital CRS (5017)
state: Washington
city: Seattle
country: United States
facility: University of Washington NICHD CRS (5029)
state: Washington
city: San Juan
country: Puerto Rico
facility: San Juan City Hosp. PR NICHD CRS (5031)
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Pediatric HIV/AIDS Research (6601)
Study officials:
affiliation: University of Colorado at Denver Health Sciences Center
name: Myron J. Levin, MD
role: STUDY_CHAIR
affiliation: Harvard School of Public Health (HSPH)
name: Paige L. Williams, PhD
role: STUDY_CHAIR
References:
citation: Patel K, Hernan MA, Williams PL, Seeger JD, McIntosh K, Van Dyke RB, Seage GR 3rd; Pediatric AIDS Clinical Trials Group 219/219C Study Team. Long-term effectiveness of highly active antiretroviral therapy on the survival of children and adolescents with HIV infection: a 10-year follow-up study. Clin Infect Dis. 2008 Feb 15;46(4):507-15. doi: 10.1086/526524.
citation: Brady MT, Oleske JM, Williams PL, Elgie C, Mofenson LM, Dankner WM, Van Dyke RB; Pediatric AIDS Clinical Trials Group219/219C Team. Declines in mortality rates and changes in causes of death in HIV-1-infected children during the HAART era. J Acquir Immune Defic Syndr. 2010 Jan;53(1):86-94. doi: 10.1097/QAI.0b013e3181b9869f.