HIV InfectionsNCT00100542
Psychiatric Problems in Children and Adolescents Infected With HIV at Birth
An observational study of HIV Infections and Mental Disorders, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 32 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether HIV and anti-HIV drugs cause mental health problems or make mental health problems worse in children and adolescents who were infected with HIV at birth. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Mental Disorders
- What is being tested?
- Psychiatric interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Apr 2005to Sep 2006
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children and their caregivers from specific clinics.
Who may be able to join
- Acquired HIV through mother-to-child transmission
- HIV uninfected
- Living with same parent or primary caregiver for at least 12 months prior to study screening
- Willing and able to provide consent or assent
Who cannot join
- Acquired HIV through adult high-risk behavior, blood transfusion, or abuse
- IQ of 69 or lower, for participants whose primary language is English. More information on this criterion can be found in the protocol.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States31 sites
University of Maryland (Pediatric)
Baltimore, Maryland, 21201
Childrens Hospital of Boston
Boston, Massachusetts, 02115
Chicago Childrens Memorial Hospital (Pediatric)
Chicago, Illinois, 60614
Childrens Hospital (U. Colorado, Denver)
Denver, Colorado, 80218-1088
Duke University (Pediatric)
Durham, North Carolina, 27710
North Broward Hospital District
Fort Lauderdale, Florida, 33316
University of Florida - Health Science Center
Jacksonville, Florida, 32209
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
Los Angeles County Medical Center/USC
Los Angeles, California, 90033
UCLA Medical Center (Pediatric)
Los Angeles, California, 90095-1752
St. Jude Childrens Research Hospital, Memphis
Memphis, Tennessee, 38105-2794
University of Miami (Pediatric)
Miami, Florida, 33136
Yale University School of Medicine
New Haven, Connecticut, 06504
New York University School of Medicine
New York, New York, 10016
Metropolitan Hospital Center
New York, New York, 10029
Mt. Sinai Medical Center
New York, New York, 10029
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4318
St. Christophers Hosp. for Children, Philadelphia
Philadelphia, Pennsylvania, 19134
4601 UCSD Mother, Child & Adolescent HIV Program
San Diego, California, 92103
UCSF, Moffitt Hospital (Pediatric)
San Francisco, California, 94143-0105
Children's Hospital and Regional Medical Center/Seattle
Seattle, Washington, 98105
Northwest Family Ctr./Harborview Medical Center
Seattle, Washington, 98105
University of Washington Medical Ctr.
Seattle, Washington, 98105
University of South Florida
St. Petersburg, Florida, 33701
State University of New York at Stony Brook
Stony Brook, New York, 11794-8111
SUNY Upstate Medical University
Syracuse, New York, 13210
Bronx Lebanon Hospital Center
The Bronx, New York, 10457
Jacobi Medical Center
The Bronx, New York, 10461
Harbor-UCLA Medical Center
Torrance, California, 90509
Howard University Hospital
Washington D.C., District of Columbia, 20060
University of Massachusetts Medical School
Worcester, Massachusetts, 01655-0001
About this study
Official title: Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents
The purpose of this study is to determine whether HIV and anti-HIV drugs cause mental health problems or make mental health problems worse in children and adolescents who were infected with HIV at birth.
Read the detailed description
Research has shown that HIV is able to penetrate the blood-brain barrier and may significantly affect the central nervous system (CNS). Although the effects of HIV on the CNS are not fully understood, there is growing evidence that the effects are psychosocial in nature; HIV infected children experience higher rates of psychiatric symptoms and hospitalizations than their uninfected counterparts. Confounding the HIV CNS relationship is evidence suggesting that the CNS effects of HIV may also be related to antiretroviral treatment. This study will examine the rates and severity of psychiatric symptoms in both HIV infected and uninfected children and adolescents. In addition, this study will determine the relationship between duration of antiretroviral treatment and psychiatric symptoms.
No treatment will be given as part of this study. The study will last for 96 weeks and be divided into two parts. In Part 1, HIV infected and uninfected participants and their caregivers will complete a series of measures and questionnaires regarding mental health, pain, and adherence to treatment. In Part 2, all participants and their caregivers will complete a subset of the original measures at Weeks 48 and 96. This follow-up part of the study will assess any long-term changes in psychiatric symptoms. In addition, a subset of HIV infected and uninfected participants and their caregivers will take part in psychiatric interviews at specified study sites. A portion of these interviews will be audio-taped.
- Conditions
- HIV Infections, Mental Disorders
- Being tested
- Psychiatric interviews
- Keywords
- Treatment Experienced, Treatment Naive, Psychopathology, Anti-Retroviral Agents, Child, Adolescent
- Medical subject headings
- HIV Infections, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric interviewsBehavioural
Measures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | All HIV infected and uninfected participants and their caregivers. Receives: Behavioral: Psychiatric interviews |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2005 (estimated)
- Study startApr 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Sharon Nachman, MD, Study chair, Department of Pediatrics, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100542
- Sponsor's protocol ID
- PACTG P1055
- Other IDs
- U01AI068632
- Status last verified
- Jan 2011
- First submitted
- 3 Jan 2005
- Last updated
- 21 Jan 2011
- Results posted
- No
Publications
Bachanas PJ, Kullgren KA, Schwartz KS, Lanier B, McDaniel JS, Smith J, Nesheim S. Predictors of psychological adjustment in school-age children infected with HIV. J Pediatr Psychol. 2001 Sep;26(6):343-52. doi: 10.1093/jpepsy/26.6.343.
PubMed 11490035De Luca A, Ciancio BC, Larussa D, Murri R, Cingolani A, Rizzo MG, Giancola ML, Ammassari A, Ortona L. Correlates of independent HIV-1 replication in the CNS and of its control by antiretrovirals. Neurology. 2002 Aug 13;59(3):342-7. doi: 10.1212/wnl.59.3.342.
PubMed 12177366Gaughan 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 15173535Lwin R, Melvin D. Paediatric HIV infection. J Child Psychol Psychiatry. 2001 May;42(4):427-38.
PubMed 11383959Mellins CA, Smith R, O'Driscoll P, Magder LS, Brouwers P, Chase C, Blasini I, Hittleman J, Llorente A, Matzen E; NIH NIAID/NICHD/NIDA-Sponsored Women and Infant Transmission Study Group. High rates of behavioral problems in perinatally HIV-infected children are not linked to HIV disease. Pediatrics. 2003 Feb;111(2):384-93. doi: 10.1542/peds.111.2.384.
PubMed 12563068Chernoff M, Nachman S, Williams P, Brouwers P, Heston J, Hodge J, Di Poalo V, Deygoo NS, Gadow KD; IMPAACT P1055 Study Team. Mental health treatment patterns in perinatally HIV-infected youth and controls. Pediatrics. 2009 Aug;124(2):627-36. doi: 10.1542/peds.2008-2441. Epub 2009 Jul 13.
PubMed 19596734Nachman S, Chernoff M, Williams P, Hodge J, Heston J, Gadow KD. Human immunodeficiency virus disease severity, psychiatric symptoms, and functional outcomes in perinatally infected youth. Arch Pediatr Adolesc Med. 2012 Jun 1;166(6):528-35. doi: 10.1001/archpediatrics.2011.1785.
PubMed 22312169
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents
- ClinicalTrials.gov ID
- NCT00100542
- Acronym / sponsor ID
- PACTG P1055
- Conditions
- HIV Infections, Mental Disorders
- Keywords
- Treatment Experienced, Treatment Naive, Psychopathology, Anti-Retroviral Agents, Child, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 4 Jan 2005 (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.
The purpose of this study is to determine whether HIV and anti-HIV drugs cause mental health problems or make mental health problems worse in children and adolescents who were infected with HIV at birth.
Detailed description
Research has shown that HIV is able to penetrate the blood-brain barrier and may significantly affect the central nervous system (CNS). Although the effects of HIV on the CNS are not fully understood, there is growing evidence that the effects are psychosocial in nature; HIV infected children experience higher rates of psychiatric symptoms and hospitalizations than their uninfected counterparts. Confounding the HIV CNS relationship is evidence suggesting that the CNS effects of HIV may also be related to antiretroviral treatment. This study will examine the rates and severity of psychiatric symptoms in both HIV infected and uninfected children and adolescents. In addition, this study will determine the relationship between duration of antiretroviral treatment and psychiatric symptoms.
No treatment will be given as part of this study. The study will last for 96 weeks and be divided into two parts. In Part 1, HIV infected and uninfected participants and their caregivers will complete a series of measures and questionnaires regarding mental health, pain, and adherence to treatment. In Part 2, all participants and their caregivers will complete a subset of the original measures at Weeks 48 and 96. This follow-up part of the study will assess any long-term changes in psychiatric symptoms. In addition, a subset of HIV infected and uninfected participants and their caregivers will take part in psychiatric interviews at specified study sites. A portion of these interviews will be audio-taped.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Psychiatric interviewsAll HIV infected and uninfected participants and their caregivers. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children and their caregivers from specific clinics.
Key inclusion criteria (4 listed)
- Acquired HIV through mother-to-child transmission
- HIV uninfected
- Living with same parent or primary caregiver for at least 12 months prior to study screening
- Willing and able to provide consent or assent
Key exclusion criteria (2 listed)
- Acquired HIV through adult high-risk behavior, blood transfusion, or abuse
- IQ of 69 or lower, for participants whose primary language is English. More information on this criterion can be found in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric interviewsMeasures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study. | Behavioural | 1 |
Primary outcome
Not reported in the source record.
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 21 Jan 2011.
- Background: PubMed 11490035Bachanas PJ, Kullgren KA, Schwartz KS, Lanier B, McDaniel JS, Smith J, Nesheim S. Predictors of psychological adjustment in school-age children infected with HIV. J Pediatr Psychol. 2001 Sep;26(6):343-52. doi: 10.1093/jpepsy/26.6.343.
- Background: PubMed 12177366De Luca A, Ciancio BC, Larussa D, Murri R, Cingolani A, Rizzo MG, Giancola ML, Ammassari A, Ortona L. Correlates of independent HIV-1 replication in the CNS and of its control by antiretrovirals. Neurology. 2002 Aug 13;59(3):342-7. doi: 10.1212/wnl.59.3.342.
- Background: PubMed 15173535Gaughan 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.
- Background: PubMed 11383959Lwin R, Melvin D. Paediatric HIV infection. J Child Psychol Psychiatry. 2001 May;42(4):427-38.
- Background: PubMed 12563068Mellins CA, Smith R, O'Driscoll P, Magder LS, Brouwers P, Chase C, Blasini I, Hittleman J, Llorente A, Matzen E; NIH NIAID/NICHD/NIDA-Sponsored Women and Infant Transmission Study Group. High rates of behavioral problems in perinatally HIV-infected children are not linked to HIV disease. Pediatrics. 2003 Feb;111(2):384-93. doi: 10.1542/peds.111.2.384.
- Results publication: PubMed 19596734Chernoff M, Nachman S, Williams P, Brouwers P, Heston J, Hodge J, Di Poalo V, Deygoo NS, Gadow KD; IMPAACT P1055 Study Team. Mental health treatment patterns in perinatally HIV-infected youth and controls. Pediatrics. 2009 Aug;124(2):627-36. doi: 10.1542/peds.2008-2441. Epub 2009 Jul 13.
- Derived from this study: PubMed 22312169Nachman S, Chernoff M, Williams P, Hodge J, Heston J, Gadow KD. Human immunodeficiency virus disease severity, psychiatric symptoms, and functional outcomes in perinatally infected youth. Arch Pediatr Adolesc Med. 2012 Jun 1;166(6):528-35. doi: 10.1001/archpediatrics.2011.1785.
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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.
Sharon Nachman, MD study chair
Department of Pediatrics, Stony Brook University
32 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 and Mental Disorders, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 32 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 4 inclusion and 2 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 21 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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 NCT00100542, which also lists 7 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 21 Jan 2011.