IMPAACT P1074: Long-Term Outcomes in HIV-Infected Infants, Children, and Adolescents

HIV Infections Clinical Trial

Official title:

A Prospective Surveillance Study of Long-Term Outcomes in HIV-Infected Infants, Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061164
• Other study ID #: IMPAACT P1074
• Secondary ID: U01AI068632
• Status: Completed
• Phase: N/A
• First received: February 1, 2010
• Last updated: March 23, 2015
• Start date: March 2009
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1207
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Puerto Rico	San Juan City Hosp. PR NICHD CRS (5031)	San Juan
Puerto Rico	University of Puerto Rico Pediatric HIV/AIDS Research (6601)	San Juan
United States	University of Colorado Denver NICHD CRS (5052)	Aurora	Colorado
United States	Johns Hopkins University NICHD CRS (5092)	Baltimore	Maryland
United States	Univ. of Alabama Birmingham NICHD CRS (5096)	Birmingham	Alabama
United States	Children's Hospital of Boston NICHD CRS (5009)	Boston	Massachusetts
United States	Bronx-Lebanon Hospital IMPAACT CRS (6901)	Bronx	New York
United States	Jacobi Medical Center Bronx (5013)	Bronx	New York
United States	Chicago Children's CRS (4001)	Chicago	Illinois
United States	Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)	Detroit	Michigan
United States	Duke Pediatric Infectious Diseases	Durham	North Carolina
United States	Duke University Medical Center (DUMC) Pediatric CRS (4701)	Durham	North Carolina
United States	South Florida CDC Ft Lauderdale NICHD CRS (5055)	Fort Lauderdale	Florida
United States	Texas Children's Hosp. CRS (3801)	Houston	Texas
United States	Univ. of Florida Jacksonville NICHD CRS (5051)	Jacksonville	Florida
United States	Miller Children's Hospital Long Beach (5093)	Long Beach	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	Usc La Nichd Crs (5048)	Los Angeles	California
United States	St. Jude/UTHSC CRS (6501)	Memphis	Tennessee
United States	Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201)	Miami	Florida
United States	Tulane University (5095)	New Orleans	Louisiana
United States	Columbia IMPAACT Center (4101)	New York	New York
United States	Metropolitan Hospital (5003)	New York	New York
United States	New York University NY (5012)	New York	New York
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	The Children's Hospital of Philadelphia IMPAACT CRS (6701)	Philadelphia	Pennsylvania
United States	Strong Memorial Hospital, University of Rochester NICHD CRS (5057)	Rochester	New York
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	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	SUNY Stony Brook (5040)	Stony Brook	New York
United States	University of South Florida Tampa (5018)	Tampa	Florida
United States	Children's National Med. Ctr. Washington DC NICHD CRS (5015)	Washington	District of Columbia
United States	Howard University Washington DC NICHD CRS (5044)	Washington	District of Columbia
United States	WNE Maternal Pediatric Adolescent AIDS CRS (7301)	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
International Maternal Pediatric Adolescent AIDS Clinical Trials Group	National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (2)

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. — View Citation

Patel K, Hernán 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No