IMPAACT P1080: Psychiatric and Antiretroviral Medication Concentrations in HIV-infected and Uninfected Children and Adolescents

Completed

• Conditions: ADHD; HIV

• Registration Number: NCT01232361
• Lead Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Brief Summary

The main purpose of this study is to find out how stimulant medications (methylphenidate or amphetamine/ dextroamphetamine) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)are processed in HIV-1 infected and HIV-uninfected children and adolescents.

Detailed Description

P1080 is a pilot population pharmacokinetic study of HIV-1 infected and uninfected children and adolescents who are taking methylphenidate or amphetamine/ dextroamphetamine for the treatment of ADHD. Prescribing various psychiatric medications in combination with antiretroviral regimens is a standard clinical practice occurring without adequate evidence regarding benefits and risks. The goals of this study are to determine plasma concentrations of psychiatric and antiretroviral medications in children and adolescents. Psychiatric medication dose requirement and exposure in HIV-1 infected subjects will be compared to that seen in uninfected children and adolescents, and antiretroviral exposure will be compared to published studies in children and adolescents.

Study Timeline

• Study Start: 2010-10-08
• Study First Submitted: 2010-10-29
• Study First Submitted QC: 2010-10-29
• Study First Posted: 2010-11-02
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimation of steady-state oral clearance (Cl/F) for each psychiatric study medication is the primary outcome.	duration of study	Additional pharmacokinetic parameters \[area under the concentration-time curve (AUC), apparent volume of distribution (Vd/F), half-life (t½), pre-dose concentration (Cpre), maximum concentration (Cmax), corresponding time of maximum concentration (Tmax), elimination rate constant (ke), and between and within-subject variability\] for the selected psychiatric medications in HIV-1 infected and uninfected children and adolescents will also be determined.

Trial Locations

Locations (22)

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601); 🇺🇸 Los Angeles, California, United States

South Florida CDC Ft Lauderdale NICHD CRS (5055); 🇺🇸 Fort Lauderdale, Florida, United States

Miller Children's Hospital Long Beach (5093); 🇺🇸 Long Beach, California, United States

Univ. of Alabama Birmingham NICHD CRS (5096); 🇺🇸 Birmingham, Alabama, United States

Usc La Nichd Crs (5048); 🇺🇸 Los Angeles, California, United States

Children's National Med. Ctr. Washington DC NICHD CRS (5015); 🇺🇸 Washington, District of Columbia, United States

Childrens Hospital (U. Colorado, Denver) NICHD CRS (5052); 🇺🇸 Denver, Colorado, United States

Boston Medical Center Ped. HIV Program NICHD CRS (5011); 🇺🇸 Boston, Massachusetts, United States

Wayne State University/Children's Hospital of Michigan NICHD CRS (5041); 🇺🇸 Detroit, Michigan, United States

Jacobi Med. Ctr. Bronx NICHD CRS (5013); 🇺🇸 Bronx, New York, United States

St. Jude Childrens Research Hospital, Memphis (6501); 🇺🇸 Memphis, Tennessee, United States

Chicago Children's CRS (4001); 🇺🇸 Chicago, Illinois, United States

Rush University Cook County Hospital NICHD CRS (5083); 🇺🇸 Chicago, Illinois, United States

WNE Maternal Pediatric Adolescent AIDS CRS (7301); 🇺🇸 Worcester, Massachusetts, United States

New York University NY (5012); 🇺🇸 New York, New York, United States

Johns Hopkins University NICHD CRS (5092); 🇺🇸 Baltimore, Maryland, United States

Columbia IMPAACT Center (4101); 🇺🇸 New York, New York, United States

SUNY Stony Brook (5040); 🇺🇸 Stony Brook, New York, United States

San Juan City Hosp. PR NICHD CRS (5031); 🇵🇷 San Juan, Puerto Rico

Texas Children's Hosp. CRS (3801); 🇺🇸 Houston, Texas, United States

Univ of California, San Diego (UCSD) (4601); 🇺🇸 San Diego, California, United States

Univ of Miami Pediatric/Perinatal HIV/AIDS (4201); 🇺🇸 Miami, Florida, United States