Long-Term Effects of HIV Exposure and Infection in Children

October 4, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Pediatric Late Outcomes Protocol

As new drugs and vaccines are developed to prevent HIV disease progression and prolong survival of HIV infected patients, the short-term safety and effectiveness of these treatments are evaluated in research studies. However, the long-term effects, whether they are benefits or side effects, need to be studied as well. These long-term effects may have a greater impact on infants and children who are still growing and developing. The purpose of this study is to follow HIV-exposed and HIV infected infants, children, and adolescents who are seen at Pediatric AIDS Clinical Trials Group (PACTG) study sites. These patients will be observed for long-term benefits or any late harmful effects of medications or vaccines.

Study Overview

Status

Completed

Conditions

Detailed Description

The potential long-term benefits, toxicities, and other adverse outcomes of new anti-HIV therapies cannot be assessed within the time frame of most clinical trials. There is a need to better assess both positive and negative late outcomes and late treatment effects in growing children. This prospective, longitudinal study will evaluate the effects and their impact on children.

Children in this study will include patients who are HIV infected, were exposed to HIV or anti-HIV drugs prior to or at the time of their birth, or children of patients followed at Pediatric AIDS Clinical Trial Group (PACTG) sites. Children will have a study visit every 3 months through the first year of life. After age 1, children who are HIV infected will continue to have study visits every 3 months, while children who are HIV uninfected will have study visits once a year. Study assessments will include complete physical exam, medical history, Tanner staging, neurologic exam, growth and quality of life assessments, and laboratory tests such as hematology, chemistries, and urinalysis. Not all assessments will be performed at each study visit. Patients will be followed until age 24.

Study Type

Observational

Enrollment

4150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Bayamon, Puerto Rico, 00956
        • Ramon Ruiz Arnau Univ Hosp / Pediatrics
      • San Juan, Puerto Rico, 009367344
        • San Juan City Hosp
      • San Juan, Puerto Rico, 009365067
        • Univ of Puerto Rico / Univ Children's Hosp AIDS
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Univ of Alabama at Birmingham - Pediatric
      • Mobile, Alabama, United States, 36604
        • Univ of South Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Phoenix Childrens Hosp
    • California
      • La Jolla, California, United States, 920930672
        • UCSD Med Ctr / Pediatrics / Clinical Sciences
      • Long Beach, California, United States, 90801
        • Long Beach Memorial (Pediatric)
      • Los Angeles, California, United States, 900276016
        • Children's Hosp of Los Angeles/UCLA Med Ctr
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • Los Angeles, California, United States, 900481804
        • Cedars Sinai / UCLA Med Ctr
      • Los Angeles, California, United States, 900951752
        • UCLA Med Ctr / Pediatric
      • Los Angeles, California, United States, 90095
        • UCLA Med Ctr / Pediatrics
      • Los Angeles, California, United States, 90095
        • UCLA Med Ctr
      • Oakland, California, United States, 946091809
        • Children's Hosp of Oakland
      • San Francisco, California, United States, 94110
        • San Francisco Gen Hosp
      • San Francisco, California, United States, 941430105
        • UCSF / Moffitt Hosp - Pediatric
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Univ of Connecticut / Farmington
      • Farmington, Connecticut, United States, 060303805
        • Connecticut Children's Med Ctr
      • New Haven, Connecticut, United States, 06504
        • Yale Univ Med School
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard Univ. Washington DC NICHD CRS
      • Washington, District of Columbia, United States, 200102916
        • Children's Hosp of Washington DC
    • Florida
      • Fort Lauderdale, Florida, United States, 33311
        • North Broward Hosp District
      • Gainesville, Florida, United States, 32610
        • Univ of Florida Gainesville
      • Jacksonville, Florida, United States, 32209
        • Univ of Florida Health Science Ctr / Pediatrics
      • Miami, Florida, United States, 33161
        • Univ of Miami (Pediatric)
      • Miami, Florida, United States, 33136
        • Univ of Miami / Jackson Memorial Hosp
      • Pensacola, Florida, United States, 32503
        • Sacred Heart Children's Hosp / CMS of Florida
      • Riviera Beach, Florida, United States, 33404
        • Palm Beach County Health Dept
      • St. Petersburg, Florida, United States, 33701
        • Univ of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30306
        • Emory Univ Hosp / Pediatrics
      • Augusta, Georgia, United States, 30912
        • Med College of Georgia
      • Columbus, Georgia, United States, 31901
        • The Med Ctr Inc
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp
      • Chicago, Illinois, United States, 606143394
        • Chicago Children's Memorial Hosp
      • Chicago, Illinois, United States, 606371470
        • Univ of Chicago Children's Hosp
      • Chicago, Illinois, United States, 60612
        • Univ of Illinois College of Medicine / Pediatrics
      • Chicago, Illinois, United States, 60608
        • Mt Sinai Hosp Med Ctr / Dept of Pediatrics
    • Louisiana
      • New Orleans, Louisiana, United States, 701122699
        • Tulane Univ / Charity Hosp of New Orleans
      • New Orleans, Louisiana, United States, 70112-2699
        • Children's Hospital of New Orleans
      • New Orleans, Louisiana, United States, 70112
        • Earl K Long Early Intervention Clinic
      • New Orleans, Louisiana, United States, 70112
        • Univ Hosp
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Univ of Maryland at Baltimore / Univ Med Ctr
      • Baltimore, Maryland, United States, 212874933
        • Johns Hopkins Hosp - Pediatric
    • Massachusetts
      • Boston, Massachusetts, United States, 021155724
        • Children's Hosp of Boston
      • Boston, Massachusetts, United States, 02118
        • Boston City Hosp / Pediatrics
      • Boston, Massachusetts, United States, 02115
        • Childrens Hospital of Boston
      • Springfield, Massachusetts, United States, 01199
        • Baystate Med Ctr of Springfield
      • Worcester, Massachusetts, United States, 016550001
        • Univ of Massachusetts Med School
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hosp of Michigan
    • Mississippi
      • Jackson, Mississippi, United States, 39213
        • Univ of Mississippi Med Ctr
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • St. Louis Children's Hosp
    • New Jersey
      • Camden, New Jersey, United States, 081031438
        • Cooper Hosp
      • New Brunswick, New Jersey, United States, 089030019
        • UMDNJ - Robert Wood Johnson Med School / Pediatrics
      • New Brunswick, New Jersey, United States, 08901-1969
        • Robert Wood Johnson AIDS Program
      • Newark, New Jersey, United States, 071032714
        • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
      • Newark, New Jersey, United States, 07103
        • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
    • New York
      • Albany, New York, United States, 12208
        • Children's Hosp at Albany Med Ctr
      • Bronx, New York, United States, 10461
        • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
      • Bronx, New York, United States, 10467
        • Montefiore Med Ctr Adolescent AIDS Program
      • Bronx, New York, United States, 10457
        • Bronx Lebanon Hosp Ctr
      • Bronx, New York, United States, 19461
        • Montefiore Medical / AECOM
      • Brooklyn, New York, United States, 11203
        • SUNY - Brooklyn
      • Great Neck, New York, United States, 11021
        • North Shore Univ Hosp
      • New Hyde Park, New York, United States, 11040
        • Schneider Children's Hosp
      • New York, New York, United States, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, United States, 10029
        • Metropolitan Hosp Ctr
      • New York, New York, United States, 10021
        • Cornell Univ Med College
      • New York, New York, United States, 10032
        • Columbia Presbyterian Med Ctr
      • New York, New York, United States, 10032
        • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
      • New York, New York, United States, 10037
        • Harlem Hosp Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr / Pediatrics
      • New York, New York, United States, 10021
        • New York Hosp - Cornell Med Ctr
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr / Pediatrics
      • Rochester, New York, United States, 146420001
        • Univ of Rochester Med Ctr
      • Stony Brook, New York, United States, 117948111
        • State Univ of New York at Stony Brook
      • Syracuse, New York, United States, 13210
        • SUNY Health Sciences Ctr at Syracuse / Pediatrics
    • North Carolina
      • Durham, North Carolina, United States, 277103499
        • Duke Univ Med Ctr
      • Durham, North Carolina, United States, 27710
        • Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
    • Ohio
      • Columbus, Ohio, United States, 432052696
        • Columbus Children's Hosp
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences Univ
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 191044318
        • Children's Hosp of Philadelphia
      • Philadelphia, Pennsylvania, United States, 191341095
        • Saint Christopher's Hosp for Children
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hosp / Brown Univ
    • South Carolina
      • Charleston, South Carolina, United States, 294253312
        • Med Univ of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 381052794
        • Saint Jude Children's Research Hosp of Memphis
      • Nashville, Tennessee, United States, 372322581
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Med Ctr of Dallas
      • Houston, Texas, United States, 77030
        • Texas Children's Hosp / Baylor Univ
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Hosp of the King's Daughters
      • Richmond, Virginia, United States, 23219
        • Med College of Virginia
    • Washington
      • Seattle, Washington, United States, 981050371
        • Children's Hospital & Medical Center / Seattle ACTU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Age 21 or younger (consent of parent or guardian required if under 18).
  • Meet 1 of the following 3 requirements: 1) enrolled in a previous version of this study; 2) perinatally exposed to HIV, HIV vaccines, or antiretroviral treatment (must enroll before first birthday); 3) HIV infected infants, children, and adolescents (and their offspring) followed at PACTG sites.

Exclusion Criteria

  • Unable to adhere to study visit schedules.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Study Chair: James Oleske
  • Study Chair: Michael Brady
  • Study Chair: Wayne Dankner

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

May 1, 2002

Study Registration Dates

First Submitted

September 27, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

October 7, 2013

Last Update Submitted That Met QC Criteria

October 4, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 219C
  • ACTG 219
  • PACTG 219C
  • 11196 (Registry Identifier: DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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