Psychiatric Problems in Children and Adolescents Infected With HIV at Birth

Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00100542

Enrollment

800

Registered

2005-01-04

Start date

2005-04-30

Completion date

2006-09-30

Last updated

2011-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Mental Disorders

Keywords

Treatment Experienced, Treatment Naive, Psychopathology, Anti-Retroviral Agents, Child, Adolescent

Brief 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.

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.

Interventions

BEHAVIORALPsychiatric interviews

Measures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

for HIV Infected Participants: * Acquired HIV through mother-to-child transmission Inclusion Criteria for HIV Uninfected Participants: * HIV uninfected Inclusion Criteria for All Participants: * Living with same parent or primary caregiver for at least 12 months prior to study screening * Willing and able to provide consent or assent

Exclusion criteria

for HIV Infected Participants: * Acquired HIV through adult high-risk behavior, blood transfusion, or abuse

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026