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HIV InfectionsNCT00006304

Long-Term Effects of HIV Exposure and Infection in Children

An observational study of HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 92 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 24 hours to 21 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections, HIV Seronegativity
How many people
4,150 participants
Where
92 sitesin 2 countries
Study dates
Start not givento May 2002
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 hours to 21 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • Unable to adhere to study visit schedules.

Trial locations and contacts

92 sites in 2 countries.

92 sites in 2 countries

United States89 sites

  • Children's Hosp at Albany Med Ctr

    Albany, New York, 12208

  • Emory Univ Hosp / Pediatrics

    Atlanta, Georgia, 30306

  • Med College of Georgia

    Augusta, Georgia, 30912

  • Univ of Maryland at Baltimore / Univ Med Ctr

    Baltimore, Maryland, 21201

  • Johns Hopkins Hosp - Pediatric

    Baltimore, Maryland, 212874933

  • Univ of Alabama at Birmingham - Pediatric

    Birmingham, Alabama, 35233

  • Children's Hosp of Boston

    Boston, Massachusetts, 021155724

  • Childrens Hospital of Boston

    Boston, Massachusetts, 02115

  • Boston City Hosp / Pediatrics

    Boston, Massachusetts, 02118

  • SUNY - Brooklyn

    Brooklyn, New York, 11203

  • Cooper Hosp

    Camden, New Jersey, 081031438

  • Med Univ of South Carolina

    Charleston, South Carolina, 294253312

  • Mt Sinai Hosp Med Ctr / Dept of Pediatrics

    Chicago, Illinois, 60608

  • Cook County Hosp

    Chicago, Illinois, 60612

  • Univ of Illinois College of Medicine / Pediatrics

    Chicago, Illinois, 60612

  • Chicago Children's Memorial Hosp

    Chicago, Illinois, 606143394

  • Univ of Chicago Children's Hosp

    Chicago, Illinois, 606371470

  • The Med Ctr Inc

    Columbus, Georgia, 31901

  • Columbus Children's Hosp

    Columbus, Ohio, 432052696

  • Children's Med Ctr of Dallas

    Dallas, Texas, 75235

  • Children's Hosp of Michigan

    Detroit, Michigan, 48201

  • Duke Univ Med Ctr

    Durham, North Carolina, 277103499

  • Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • Connecticut Children's Med Ctr

    Farmington, Connecticut, 060303805

  • Univ of Connecticut / Farmington

    Farmington, Connecticut, 06032

  • North Broward Hosp District

    Fort Lauderdale, Florida, 33311

  • Univ of Florida Gainesville

    Gainesville, Florida, 32610

  • North Shore Univ Hosp

    Great Neck, New York, 11021

  • Texas Children's Hosp / Baylor Univ

    Houston, Texas, 77030

  • Univ of Mississippi Med Ctr

    Jackson, Mississippi, 39213

  • Univ of Florida Health Science Ctr / Pediatrics

    Jacksonville, Florida, 32209

  • UCSD Med Ctr / Pediatrics / Clinical Sciences

    La Jolla, California, 920930672

  • Long Beach Memorial (Pediatric)

    Long Beach, California, 90801

  • Children's Hosp of Los Angeles/UCLA Med Ctr

    Los Angeles, California, 900276016

  • Los Angeles County - USC Med Ctr

    Los Angeles, California, 90033

  • Cedars Sinai / UCLA Med Ctr

    Los Angeles, California, 900481804

  • UCLA Med Ctr / Pediatric

    Los Angeles, California, 900951752

  • UCLA Med Ctr / Pediatrics

    Los Angeles, California, 90095

  • UCLA Med Ctr

    Los Angeles, California, 90095

  • Saint Jude Children's Research Hosp of Memphis

    Memphis, Tennessee, 381052794

  • Univ of Miami / Jackson Memorial Hosp

    Miami, Florida, 33136

  • Univ of Miami (Pediatric)

    Miami, Florida, 33161

  • Univ of South Alabama

    Mobile, Alabama, 36604

  • Vanderbilt Univ Med Ctr

    Nashville, Tennessee, 372322581

  • Robert Wood Johnson AIDS Program

    New Brunswick, New Jersey, 08901-1969

  • UMDNJ - Robert Wood Johnson Med School / Pediatrics

    New Brunswick, New Jersey, 089030019

  • Yale Univ Med School

    New Haven, Connecticut, 06504

  • Schneider Children's Hosp

    New Hyde Park, New York, 11040

  • Children's Hospital of New Orleans

    New Orleans, Louisiana, 70112-2699

  • Tulane Univ / Charity Hosp of New Orleans

    New Orleans, Louisiana, 701122699

  • Earl K Long Early Intervention Clinic

    New Orleans, Louisiana, 70112

  • Univ Hosp

    New Orleans, Louisiana, 70112

  • Beth Israel Med Ctr / Pediatrics

    New York, New York, 10003

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Cornell Univ Med College

    New York, New York, 10021

  • New York Hosp - Cornell Med Ctr

    New York, New York, 10021

  • Metropolitan Hosp Ctr

    New York, New York, 10029

  • Mount Sinai Med Ctr / Pediatrics

    New York, New York, 10029

  • Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Harlem Hosp Ctr

    New York, New York, 10037

  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp

    Newark, New Jersey, 071032714

  • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl

    Newark, New Jersey, 07103

  • Children's Hosp of the King's Daughters

    Norfolk, Virginia, 23507

  • Children's Hosp of Oakland

    Oakland, California, 946091809

  • Sacred Heart Children's Hosp / CMS of Florida

    Pensacola, Florida, 32503

  • Children's Hosp of Philadelphia

    Philadelphia, Pennsylvania, 191044318

  • Saint Christopher's Hosp for Children

    Philadelphia, Pennsylvania, 191341095

  • Phoenix Childrens Hosp

    Phoenix, Arizona, 85006

  • Oregon Health Sciences Univ

    Portland, Oregon, 97201

  • Rhode Island Hosp / Brown Univ

    Providence, Rhode Island, 02903

  • Med College of Virginia

    Richmond, Virginia, 23219

  • Palm Beach County Health Dept

    Riviera Beach, Florida, 33404

  • Univ of Rochester Med Ctr

    Rochester, New York, 146420001

  • San Francisco Gen Hosp

    San Francisco, California, 94110

  • UCSF / Moffitt Hosp - Pediatric

    San Francisco, California, 941430105

  • Children's Hospital & Medical Center / Seattle ACTU

    Seattle, Washington, 981050371

  • Baystate Med Ctr of Springfield

    Springfield, Massachusetts, 01199

  • St. Louis Children's Hosp

    St Louis, Missouri, 63110

  • Univ of South Florida

    St. Petersburg, Florida, 33701

  • State Univ of New York at Stony Brook

    Stony Brook, New York, 117948111

  • SUNY Health Sciences Ctr at Syracuse / Pediatrics

    Syracuse, New York, 13210

  • Bronx Lebanon Hosp Ctr

    The Bronx, New York, 10457

  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr

    The Bronx, New York, 10461

  • Montefiore Med Ctr Adolescent AIDS Program

    The Bronx, New York, 10467

  • Montefiore Medical / AECOM

    The Bronx, New York, 19461

  • Children's Hosp of Washington DC

    Washington D.C., District of Columbia, 200102916

  • Howard Univ. Washington DC NICHD CRS

    Washington D.C., District of Columbia, 20060

  • Univ of Massachusetts Med School

    Worcester, Massachusetts, 016550001

Other trials in United States

Puerto Rico3 sites

  • Ramon Ruiz Arnau Univ Hosp / Pediatrics

    Bayamón, 00956

  • Univ of Puerto Rico / Univ Children's Hosp AIDS

    San Juan, 009365067

  • San Juan City Hosp

    San Juan, 009367344

Other trials in Puerto Rico

About this study

Official title: 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.

Read the 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.

Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionMay 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
4,150 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006304
Sponsor's protocol ID
ACTG 219C
Other IDs
ACTG 219, PACTG 219C, 11196
Status last verified
Oct 2013
First submitted
27 Sep 2000
Last updated
7 Oct 2013
Results posted
No

Publications

  • Brady MT, Clark C, Weedy C, Fowler M, Mofenson L, Oleske J. Disclosure of HIV diagnosis to children in ACTG clinical trials (ACTG 219). Int Conf AIDS. 1996 Jul 7-12;11(2):43 (abstract no WeD131)

  • Gaughan DM, Mofeson LM, Hughes MD, Seage GR, Oleske JM. Avascular necrosis of the hip (Leggs-Calve-Perthes disease [LCPD]) in HIV-infected children in long-term follow-up: PACTG study 219. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 638)

  • Buchacz K, Cervia JS, Lindsey JC, Hughes MD, Seage GR 3rd, Dankner WM, Oleske JM, Moye J. Impact of protease inhibitor-containing combination antiretroviral therapies on height and weight growth in HIV-infected children. Pediatrics. 2001 Oct;108(4):E72. doi: 10.1542/peds.108.4.e72.

    PubMed 11581480

  • Culnane M, Fowler M, Lee SS, McSherry G, Brady M, O'Donnell K, Mofenson L, Gortmaker SL, Shapiro DE, Scott G, Jimenez E, Moore EC, Diaz C, Flynn PM, Cunningham B, Oleske J. Lack of long-term effects of in utero exposure to zidovudine among uninfected children born to HIV-infected women. Pediatric AIDS Clinical Trials Group Protocol 219/076 Teams. JAMA. 1999 Jan 13;281(2):151-7. doi: 10.1001/jama.281.2.151.

    PubMed 9917118

  • Gaughan DM, Mofenson LM, Hughes MD, Seage GR 3rd, Ciupak GL, Oleske JM; Pediatric AIDS Clinical Trials Group Protocol 219 Team. Osteonecrosis of the hip (Legg-Calve-Perthes disease) in human immunodeficiency virus-infected children. Pediatrics. 2002 May;109(5):E74-4. doi: 10.1542/peds.109.5.e74.

    PubMed 11986480

  • Hanson IC, Antonelli TA, Sperling RS, Oleske JM, Cooper E, Culnane M, Fowler MG, Kalish LA, Lee SS, McSherry G, Mofenson L, Shapiro DE. Lack of tumors in infants with perinatal HIV-1 exposure and fetal/neonatal exposure to zidovudine. J Acquir Immune Defic Syndr Hum Retrovirol. 1999 Apr 15;20(5):463-7. doi: 10.1097/00042560-199904150-00008.

    PubMed 10225228

  • Gaughan DM, Hughes MD, Seage GR 3rd, Selwyn PA, Carey VJ, Gortmaker SL, Oleske JM. The prevalence of pain in pediatric human immunodeficiency virus/acquired immunodeficiency syndrome as reported by participants in the Pediatric Late Outcomes Study (PACTG 219). Pediatrics. 2002 Jun;109(6):1144-52. doi: 10.1542/peds.109.6.1144.

    PubMed 12042556

  • Gortmaker SL, Hughes M, Cervia J, Brady M, Johnson GM, Seage GR 3rd, Song LY, Dankner WM, Oleske JM; Pediatric AIDS Clinical Trials Group Protocol 219 Team. Effect of combination therapy including protease inhibitors on mortality among children and adolescents infected with HIV-1. N Engl J Med. 2001 Nov 22;345(21):1522-8. doi: 10.1056/NEJMoa011157.

    PubMed 11794218

  • Howland LC, Gortmaker SL, Mofenson LM, Spino C, Gardner JD, Gorski H, Fowler MG, Oleske J. Effects of negative life events on immune suppression in children and youth infected with human immunodeficiency virus type 1. Pediatrics. 2000 Sep;106(3):540-6. doi: 10.1542/peds.106.3.540.

    PubMed 10969100

  • Nucleoside exposure in the children of HIV-infected women receiving antiretroviral drugs: absence of clear evidence for mitochondrial disease in children who died before 5 years of age in five United States cohorts. J Acquir Immune Defic Syndr. 2000 Nov 1;25(3):261-8. doi: 10.1097/00126334-200011010-00009.

    PubMed 11115957

  • Gaughan DM, Hughes MD, Oleske JM, Malee K, Gore CA, Nachman S; Pediatric AIDS Clinical Trials Group 219C Team. Psychiatric hospitalizations among children and youths with human immunodeficiency virus infection. Pediatrics. 2004 Jun;113(6):e544-51. doi: 10.1542/peds.113.6.e544.

    PubMed 15173535

  • Farley J, Gona P, Crain M, Cervia J, Oleske J, Seage G, Lindsey J; Pediatric AIDS Clinical Trials Group Study 219C Team. Prevalence of elevated cholesterol and associated risk factors among perinatally HIV-infected children (4-19 years old) in Pediatric AIDS Clinical Trials Group 219C. J Acquir Immune Defic Syndr. 2005 Apr 1;38(4):480-7. doi: 10.1097/01.qai.0000139397.30612.96.

    PubMed 15764965

  • Kest H, Brogly S, McSherry G, Dashefsky B, Oleske J, Seage GR 3rd. Malignancy in perinatally human immunodeficiency virus-infected children in the United States. Pediatr Infect Dis J. 2005 Mar;24(3):237-42. doi: 10.1097/01.inf.0000154324.59426.8d.

    PubMed 15750460

  • Brogly S, Williams P, Seage GR 3rd, Oleske JM, Van Dyke R, McIntosh K; PACTG 219C Team. Antiretroviral treatment in pediatric HIV infection in the United States: from clinical trials to clinical practice. JAMA. 2005 May 11;293(18):2213-20. doi: 10.1001/jama.293.18.2213.

    PubMed 15886376

  • Gona P, Van Dyke RB, Williams PL, Dankner WM, Chernoff MC, Nachman SA, Seage GR 3rd. Incidence of opportunistic and other infections in HIV-infected children in the HAART era. JAMA. 2006 Jul 19;296(3):292-300. doi: 10.1001/jama.296.3.292.

    PubMed 16849662

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 92 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006304, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2013.

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