HIV InfectionsNCT01061164
IMPAACT P1074: Long-Term Outcomes in HIV-Infected Infants, Children, and Adolescents
An observational study of HIV Infections, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 39 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- How many people
- 1,207 participants
- Where
- 39 sitesin 2 countries
- Study dates
- Mar 2009to Jun 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include participants in PACTG 219C or select IMPAACT treatment studies.
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States37 sites
University of Colorado Denver NICHD CRS (5052)
Aurora, Colorado, 80045
Johns Hopkins University NICHD CRS (5092)
Baltimore, Maryland, 21287
Univ. of Alabama Birmingham NICHD CRS (5096)
Birmingham, Alabama, 35294
Children's Hospital of Boston NICHD CRS (5009)
Boston, Massachusetts, 02115
Chicago Children's CRS (4001)
Chicago, Illinois, 60614
Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)
Detroit, Michigan, 48201
Duke Pediatric Infectious Diseases
Durham, North Carolina, 27710-3499
Duke University Medical Center (DUMC) Pediatric CRS (4701)
Durham, North Carolina, 27710
South Florida CDC Ft Lauderdale NICHD CRS (5055)
Fort Lauderdale, Florida, 33316
Texas Children's Hosp. CRS (3801)
Houston, Texas, 77030
Univ. of Florida Jacksonville NICHD CRS (5051)
Jacksonville, Florida, 32209
Miller Children's Hospital Long Beach (5093)
Long Beach, California, 90806
Usc La Nichd Crs (5048)
Los Angeles, California, 90033
Childrens Hospital Los Angeles (5090)
Los Angeles, California, 90054
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
Los Angeles, California, 90095
St. Jude/UTHSC CRS (6501)
Memphis, Tennessee, 38105-2794
Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201)
Miami, Florida, 33136
Tulane University (5095)
New Orleans, Louisiana, 70112
New York University NY (5012)
New York, New York, 10016
Metropolitan Hospital (5003)
New York, New York, 10029
Columbia IMPAACT Center (4101)
New York, New York, 10032
New Jersey Medical School (NJ) (2802)
Newark, New Jersey, 07103
Univ of Med & Dentistry of New Jersey/Univ Hosp
Newark, New Jersey, 07103
The Children's Hospital of Philadelphia IMPAACT CRS (6701)
Philadelphia, Pennsylvania, 19104
Strong Memorial Hospital, University of Rochester NICHD CRS (5057)
Rochester, New York, 14642
UCSD Mother, Child & Adolescent HIV Program(4601)
San Diego, California, 92103
Univ. of California San Francisco NICHD CRS (5091)
San Francisco, California, 94117
Harborview Medical Center NICHD CRS (5027)
Seattle, Washington, 98105
Seattle Children's Hospital CRS (5017)
Seattle, Washington, 98105
University of Washington NICHD CRS (5029)
Seattle, Washington, 98105
SUNY Stony Brook (5040)
Stony Brook, New York, 11794-8111
University of South Florida Tampa (5018)
Tampa, Florida, 33620
Bronx-Lebanon Hospital IMPAACT CRS (6901)
The Bronx, New York, 10457
Jacobi Medical Center Bronx (5013)
The Bronx, New York, 10461
Children's National Med. Ctr. Washington DC NICHD CRS (5015)
Washington D.C., District of Columbia, 20010
Howard University Washington DC NICHD CRS (5044)
Washington D.C., District of Columbia, 20060
WNE Maternal Pediatric Adolescent AIDS CRS (7301)
Worcester, Massachusetts, 01605
Puerto Rico2 sites
San Juan City Hosp. PR NICHD CRS (5031)
San Juan, 00927
University of Puerto Rico Pediatric HIV/AIDS Research (6601)
San Juan, 00936-5067
About this study
Official title: A Prospective Surveillance Study of Long-Term Outcomes in HIV-Infected Infants, Children and Adolescents
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.
Read the 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.
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected infants, children, and adolescents | Infants, children, and adolescents with HIV infection who have participated in PACTG 219C and/or select IMPAACT studies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startMar 2009
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,207 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Myron J. Levin, MD, Study chair, University of Colorado at Denver Health Sciences CenterPaige L. Williams, PhD, Study chair, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061164
- Sponsor's protocol ID
- IMPAACT P1074
- Other IDs
- U01AI068632
- Status last verified
- Oct 2014
- First submitted
- 1 Feb 2010
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18199042Brady 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.
PubMed 20035164
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Surveillance Study of Long-Term Outcomes in HIV-Infected Infants, Children and Adolescents
- ClinicalTrials.gov ID
- NCT01061164
- Acronym / sponsor ID
- IMPAACT P1074
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,207 participants (actual)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Mar 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-infected infants, children, and adolescents | – | –Infants, children, and adolescents with HIV infection who have participated in PACTG 219C and/or select IMPAACT studies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include participants in PACTG 219C or select IMPAACT treatment studies.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Background: PubMed 18199042Patel 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.
- Background: PubMed 20035164Brady 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myron J. Levin, MD study chair
University of Colorado at Denver Health Sciences Center
Paige L. Williams, PhD study chair
Harvard School of Public Health (HSPH)
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 39 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 5 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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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.
What does the primary outcome measure?
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 (time frame: Throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01061164, which also lists 2 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 25 Mar 2015.