IMPAACT P1074: Long-Term Outcomes in HIV-Infected Infants, Children, and Adolescents
NCT ID: NCT01061164
Last Updated: 2015-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1207 participants
OBSERVATIONAL
2009-03-31
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
NCT05154513
Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
NCT01061151
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
NCT02140255
Long-Term Effects of HIV Exposure and Infection in Children
NCT00006304
Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations for HIV-1 PMTCT in Pregnant and Breastfeeding Women : a Phase 3 Trial
NCT00936195
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HIV-infected infants, children, and adolescents
Infants, children, and adolescents with HIV infection who have participated in PACTG 219C and/or select IMPAACT studies.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 ([email protected]).
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 ([email protected]).
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Myron J. Levin, MD
Role: STUDY_CHAIR
University of Colorado at Denver Health Sciences Center
Paige L. Williams, PhD
Role: STUDY_CHAIR
Harvard School of Public Health (HSPH)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univ. of Alabama Birmingham NICHD CRS (5096)
Birmingham, Alabama, United States
Miller Children's Hospital Long Beach (5093)
Long Beach, California, United States
Usc La Nichd Crs (5048)
Los Angeles, California, United States
Childrens Hospital Los Angeles (5090)
Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
Los Angeles, California, United States
UCSD Mother, Child & Adolescent HIV Program(4601)
San Diego, California, United States
Univ. of California San Francisco NICHD CRS (5091)
San Francisco, California, United States
University of Colorado Denver NICHD CRS (5052)
Aurora, Colorado, United States
Children's National Med. Ctr. Washington DC NICHD CRS (5015)
Washington D.C., District of Columbia, United States
Howard University Washington DC NICHD CRS (5044)
Washington D.C., District of Columbia, United States
South Florida CDC Ft Lauderdale NICHD CRS (5055)
Fort Lauderdale, Florida, United States
Univ. of Florida Jacksonville NICHD CRS (5051)
Jacksonville, Florida, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201)
Miami, Florida, United States
University of South Florida Tampa (5018)
Tampa, Florida, United States
Chicago Children's CRS (4001)
Chicago, Illinois, United States
Tulane University (5095)
New Orleans, Louisiana, United States
Johns Hopkins University NICHD CRS (5092)
Baltimore, Maryland, United States
Children's Hospital of Boston NICHD CRS (5009)
Boston, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS (7301)
Worcester, Massachusetts, United States
Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)
Detroit, Michigan, United States
New Jersey Medical School (NJ) (2802)
Newark, New Jersey, United States
Univ of Med & Dentistry of New Jersey/Univ Hosp
Newark, New Jersey, United States
New York University NY (5012)
New York, New York, United States
Metropolitan Hospital (5003)
New York, New York, United States
Columbia IMPAACT Center (4101)
New York, New York, United States
Strong Memorial Hospital, University of Rochester NICHD CRS (5057)
Rochester, New York, United States
SUNY Stony Brook (5040)
Stony Brook, New York, United States
Bronx-Lebanon Hospital IMPAACT CRS (6901)
The Bronx, New York, United States
Jacobi Medical Center Bronx (5013)
The Bronx, New York, United States
Duke Pediatric Infectious Diseases
Durham, North Carolina, United States
Duke University Medical Center (DUMC) Pediatric CRS (4701)
Durham, North Carolina, United States
The Children's Hospital of Philadelphia IMPAACT CRS (6701)
Philadelphia, Pennsylvania, United States
St. Jude/UTHSC CRS (6501)
Memphis, Tennessee, United States
Texas Children's Hosp. CRS (3801)
Houston, Texas, United States
Harborview Medical Center NICHD CRS (5027)
Seattle, Washington, United States
Seattle Children's Hospital CRS (5017)
Seattle, Washington, United States
University of Washington NICHD CRS (5029)
Seattle, Washington, United States
San Juan City Hosp. PR NICHD CRS (5031)
San Juan, , Puerto Rico
University of Puerto Rico Pediatric HIV/AIDS Research (6601)
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IMPAACT P1074
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.