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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01061164
First received: February 1, 2010
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Surveillance Study of Long-Term Outcomes in HIV-Infected Infants, Children and Adolescents

Resource links provided by NLM:


Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Primary Outcome Measures:
  • 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 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: March 2009
Estimated Study Completion Date: June 2016
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV-infected infants, children, and adolescents
Infants, children, and adolescents with HIV infection who have participated in PACTG 219C and/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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061164

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

Publications:
Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01061164     History of Changes
Other Study ID Numbers: IMPAACT P1074, U01AI068632
Study First Received: February 1, 2010
Last Updated: December 12, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 28, 2014