IMPAACT P1074: 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.

Study Overview

• Status: Completed
• Conditions: HIV Infections

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.

• Study Type: Observational
• Enrollment (Actual): 1207

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00927
    • San Juan City Hosp. PR NICHD CRS (5031)
  • San Juan, Puerto Rico, 00936-5067
    • University of Puerto Rico Pediatric HIV/AIDS Research (6601)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Univ. of Alabama Birmingham NICHD CRS (5096)
  • California
    • Long Beach, California, United States, 90806
      • Miller Children's Hospital Long Beach (5093)
    • Los Angeles, California, United States, 90033
      • Usc La Nichd Crs (5048)
    • Los Angeles, California, United States, 90095
      • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
    • Los Angeles, California, United States, 90054
      • Childrens Hospital Los Angeles (5090)
    • San Diego, California, United States, 92103
      • UCSD Mother, Child & Adolescent HIV Program(4601)
    • San Francisco, California, United States, 94117
      • Univ. of California San Francisco NICHD CRS (5091)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver NICHD CRS (5052)
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Med. Ctr. Washington DC NICHD CRS (5015)
    • Washington, District of Columbia, United States, 20060
      • Howard University Washington DC NICHD CRS (5044)
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • South Florida CDC Ft Lauderdale NICHD CRS (5055)
    • Jacksonville, Florida, United States, 32209
      • Univ. of Florida Jacksonville NICHD CRS (5051)
    • Miami, Florida, United States, 33136
      • Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201)
    • Tampa, Florida, United States, 33620
      • University of South Florida Tampa (5018)
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Chicago Children's CRS (4001)
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University (5095)
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University NICHD CRS (5092)
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital of Boston NICHD CRS (5009)
    • Worcester, Massachusetts, United States, 01605
      • WNE Maternal Pediatric Adolescent AIDS CRS (7301)
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • New Jersey Medical School (NJ) (2802)
    • Newark, New Jersey, United States, 07103
      • Univ of Med & Dentistry of New Jersey/Univ Hosp
  • New York
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center Bronx (5013)
    • Bronx, New York, United States, 10457
      • Bronx-Lebanon Hospital IMPAACT CRS (6901)
    • New York, New York, United States, 10016
      • New York University NY (5012)
    • New York, New York, United States, 10029
      • Metropolitan Hospital (5003)
    • New York, New York, United States, 10032
      • Columbia IMPAACT Center (4101)
    • Rochester, New York, United States, 14642
      • Strong Memorial Hospital, University of Rochester NICHD CRS (5057)
    • Stony Brook, New York, United States, 11794-8111
      • SUNY Stony Brook (5040)
  • North Carolina
    • Durham, North Carolina, United States, 27710-3499
      • Duke Pediatric Infectious Diseases
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center (DUMC) Pediatric CRS (4701)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia IMPAACT CRS (6701)
  • Tennessee
    • Memphis, Tennessee, United States, 38105-2794
      • St. Jude/UTHSC CRS (6501)
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hosp. CRS (3801)
  • Washington
    • Seattle, Washington, United States, 98105
      • Harborview Medical Center NICHD CRS (5027)
    • Seattle, Washington, United States, 98105
      • University of Washington NICHD CRS (5029)
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital CRS (5017)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HIV-infected infants, children, and adolescents; Infants, children, and adolescents with HIV infection who have participated in PACTG 219C and/or select IMPAACT studies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Throughout the study

Collaborators and Investigators

• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: 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 (HSPH)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 1, 2010
• First Submitted That Met QC Criteria: February 1, 2010
• First Posted (Estimate): February 2, 2010

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: IMPAACT P1074; U01AI068632 (U.S. NIH Grant/Contract)