Psychiatric Problems in Children and Adolescents Infected With HIV at Birth

Completed

• Conditions: HIV Infections; Mental Disorders

• Registration Number: NCT00100542
• Lead Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

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.

Study Timeline

• Study First Submitted: 2005-01-03
• Study First Submitted QC: 2005-01-03
• Study First Posted: 2005-01-04
• Study Start: 2005-04
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (32)

Long Beach Memorial (Pediatric); 🇺🇸 Long Beach, California, United States

Los Angeles County Medical Center/USC; 🇺🇸 Los Angeles, California, United States

UCLA Medical Center (Pediatric); 🇺🇸 Los Angeles, California, United States

4601 UCSD Mother, Child & Adolescent HIV Program; 🇺🇸 San Diego, California, United States

UCSF, Moffitt Hospital (Pediatric); 🇺🇸 San Francisco, California, United States

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

Childrens Hospital (U. Colorado, Denver); 🇺🇸 Denver, Colorado, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Howard University Hospital; 🇺🇸 Washington, District of Columbia, United States

North Broward Hospital District; 🇺🇸 Fort Lauderdale, Florida, United States

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