IMPAACT P1074: Long-Term Outcomes in HIV-Infected Infants, Children, and Adolescents
- Conditions
- HIV Infections
- Registration Number
- NCT01061164
- Lead Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1207
- 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)
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
Childrens Hospital Los Angeles (5090)
🇺🇸Los Angeles, California, United States
Univ of Med & Dentistry of New Jersey/Univ Hosp
🇺🇸Newark, New Jersey, United States
SUNY Stony Brook (5040)
🇺🇸Stony Brook, New York, United States
Seattle Children's Hospital CRS (5017)
🇺🇸Seattle, Washington, United States
Duke Pediatric Infectious Diseases
🇺🇸Durham, North Carolina, United States
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
University of Colorado Denver NICHD CRS (5052)
🇺🇸Aurora, Colorado, United States
UCSD Mother, Child & Adolescent HIV Program(4601)
🇺🇸San Diego, 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
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
🇺🇸Los Angeles, California, United States
Univ. of California San Francisco NICHD CRS (5091)
🇺🇸San Francisco, California, United States
Children's National Med. Ctr. Washington DC NICHD CRS (5015)
🇺🇸Washington, District of Columbia, United States
Johns Hopkins University NICHD CRS (5092)
🇺🇸Baltimore, Maryland, United States
Metropolitan Hospital (5003)
🇺🇸New York, New York, United States
Children's Hospital of Boston NICHD CRS (5009)
🇺🇸Boston, Massachusetts, United States
Harborview Medical Center NICHD CRS (5027)
🇺🇸Seattle, Washington, United States
The Children's Hospital of Philadelphia IMPAACT CRS (6701)
🇺🇸Philadelphia, Pennsylvania, United States
Texas Children's Hosp. CRS (3801)
🇺🇸Houston, Texas, United States
Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)
🇺🇸Detroit, Michigan, United States
New York University NY (5012)
🇺🇸New York, New York, United States
New Jersey Medical School (NJ) (2802)
🇺🇸Newark, New Jersey, United States
University of Washington NICHD CRS (5029)
🇺🇸Seattle, Washington, United States
San Juan City Hosp. PR NICHD CRS (5031)
🇵🇷San Juan, Puerto Rico
Bronx-Lebanon Hospital IMPAACT CRS (6901)
🇺🇸Bronx, New York, United States
University of Puerto Rico Pediatric HIV/AIDS Research (6601)
🇵🇷San Juan, Puerto Rico
Jacobi Medical Center Bronx (5013)
🇺🇸Bronx, 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
Duke University Medical Center (DUMC) Pediatric CRS (4701)
🇺🇸Durham, North Carolina, United States
University of South Florida Tampa (5018)
🇺🇸Tampa, Florida, United States
WNE Maternal Pediatric Adolescent AIDS CRS (7301)
🇺🇸Worcester, Massachusetts, United States
Chicago Children's CRS (4001)
🇺🇸Chicago, Illinois, United States
Univ. of Florida Jacksonville NICHD CRS (5051)
🇺🇸Jacksonville, Florida, United States
South Florida CDC Ft Lauderdale NICHD CRS (5055)
🇺🇸Fort Lauderdale, Florida, United States
Howard University Washington DC NICHD CRS (5044)
🇺🇸Washington, District of Columbia, United States
Tulane University (5095)
🇺🇸New Orleans, Louisiana, United States