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

Information source: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: ADHD; HIV

Phase: N/A

Status: Enrolling by invitation

Sponsored by: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Official(s) and/or principal investigator(s):
Brookie Best, MD, Study Chair, Affiliation: University of California, San Diego/IMPAACT

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Estimation of steady-state oral clearance (Cl/F) for each psychiatric study medication is the primary outcome.

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.

Eligibility

Minimum age: 6 Years. Maximum age: 25 Years. Gender(s): Both.

Criteria:

Inclusion Criteria for HIV-1 Infected Subjects

- Children and adolescents age ≥6 to <25 years at entry.

- Documented HIV-1 infection defined as positive test results obtained from 2 different

samples. Tests may include two of the same type OR two different types of tests listed below, as long as they are positive test results obtained from the 2 different samples:

- HIV-1 DNA PCR

- HIV-1 culture

- HIV-1 RNA PCR > 5,000 copies/mL

- HIV-1 p24 antigen detection

- HIV-1 antibody test (any licensed ELISA test kit, and confirmation by either

serum HIV-1 antigen test, HIV-1 antibody test done by a method that is not an ELISA, Western blot, or plasma HIV-1 RNA)

- Subject must be taking antiretroviral medications for clinical care for at least 4

weeks prior to pharmacokinetic sampling, with no changes in drugs, doses or formulations.

- Subject must be taking either efavirenz (EFV) OR a PI with ritonavir (RTV) OR

lopinavir/ritonavir as part of combination antiretroviral therapy. Note that RTV dosing must be as a "booster" for the protease inhibitor. Protease inhibitors may be any of the following: atazanavir, darunavir, fosamprenavir, indinavir, saquinavir or tipranavir. Subjects may not be taking more than one full-dose PI. Subjects may not be taking EFV in addition to lopinavir/ritonavir or other PI.

- Subject must be taking methylphenidate or amphetamine/ dextroamphetamine for

treatment of ADHD for at least 1 week prior to enrollment.

- Allowable methylphenidate formulations include: immediate-release (Methylin,

Ritalin or other generic, Focalin), sustained-release (Ritalin SR, Metadate ER or generic), or biphasic (Ritalin LA, Metadate CD, Concerta, Focalin XR).

- Allowable formulations for amphetamine/ dextroamphetamine include: Adderall,

Adderall XR, Dexedrine, Liquadd, and Dexedrine Spansules(and any generic equivalents).

- For both study arms, any dose up to the maximum FDA-approved dose by age will be

allowed.

- Subjects must be able to come in for PK sampling after at least 2 days of

consecutive, uninterrupted psychiatric and antiretroviral medication delivery.

- Parent/primary caregiver, subjects >18 years or emancipated minors must be able and

willing to provide signed informed consent. Assent of the minor subject should be obtained where required per site procedures and IRB recommendations.

- Female subjects of reproductive potential (having reached menses, or not having

reached menopause or not having undergone hysterectomy, bilateral oophorectomy, or tubal ligation) who engage in sexual activity that could lead to pregnancy must agree to avoid pregnancy during the entire trial and to consistently and appropriately use at least two of the following contraception methods: condoms, diaphragm or cervical cap with spermicide, IUD, hormonal-based contraception. A list of acceptable methods can be found at the FDA Birth Control Guide (http://www. fda. gov/fdac/features/1997/babyguide. pdf).

- Note: "Female subjects of reproductive potential" is defined as girls who have

reached menarche or women who have not been post-menopausal for at least 24 consecutive months (e. g. who have had menses within the preceding 24 months), or have not undergone a sterilization procedure (hysterectomy, bilateral oophorectomy or salpingotomy). If the female subject is not of reproductive potential, she is eligible without requiring contraception. Inclusion Criteria for HIV Uninfected Subjects

- Children and adolescents age ≥6 to <25 years at entry.

- Subject is not known to be HIV-1 infected.

- Note: For perinatally-exposed subjects, definitive exclusion of HIV-1 infection

in a non-breastfed infant is based on two or more negative virologic tests, with one obtained at age ≥1 month and one at ≥4 months, or two negative HIV-1 antibody tests from separate specimens obtained at age ≥6 months. Per current CDC guidelines, uninfected subjects ≥13 years will be screened for HIV-1. A documented negative HIV-1 antibody screening test or negative HIV-1 RNA or DNA PCR within the past year will be accepted to fulfill this criterion.

- Subject must be taking methylphenidate or amphetamine/ dextroamphetamine for

treatment of ADHD for at least one week prior to enrollment.

- Allowable methylphenidate formulations include: immediate-release (Methylin,

Ritalin or other generic, Focalin), sustained-release (Methylin ER, Ritalin SR, Metadate ER or generic), or biphasic (Ritalin LA, Metadate CD, Concerta and Focalin XR.

- Allowable formulations for amphetamine/ dextroamphetamine include: Adderall,

Adderall XR, Dexedrine, Liquadd, and Dexedrine Spansules (and any generic equivalents).

- For both arms, any dose up to the maximum FDA-approved dose by age will be

allowed.

- Subjects must be able to come in for PK sampling after at least 2 days of

consecutive, uninterrupted psychiatric medication delivery.

- Parent/primary caregiver, subjects >18 years or emancipated minors must be able and

willing to provide signed informed consent. Assent of the minor subject should be obtained where required per site procedures and IRB recommendations.

- Female subjects of child bearing potential (having reached menses, or not having

reached menopause or not having undergone hysterectomy, bilateral oophorectomy, or tubal ligation) who engage in sexual activity that could lead to pregnancy must agree to avoid pregnancy during the entire trial and to consistently and appropriately use at least two of the following contraception methods: condoms, diaphragm or cervical cap with spermicide, IUD, hormonal-based contraception. A list of acceptable methods can be found at the FDA Birth Control Guide (http://www. fda. gov/fdac/features/1997/babyguide. pdf).

- Note: "Female subjects of child bearing potential" is defined as girls who have

reached menarche or women who have not been post-menopausal for at least 24 consecutive months (e. g. who have had menses within the preceding 24 months), or have not undergone a sterilization procedure (hysterectomy, bilateral oophorectomy or salpingotomy). If the female subject is not of child bearing potential, she is eligible without requiring contraception. Exclusion Criteria for All Study Subjects

- A positive urine test at screening for use of the following disallowed drugs:

methamphetamine; methadone, barbiturates; benzodiazepines; opiates; phencyclidine; or propoxyphene.

- Note: If propoxyphene is not part of the routine screening panel at the site, it

is not required. If propoxyphene is part of the routine screening panel at the site, the results should be recorded on the appropriate CRF.

- Chemotherapy for malignancy within three months prior to study screening.

- Pregnancy or breastfeeding an infant.

- Any clinically significant diseases (other than HIV-1 infection) or clinically

significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study.

- Study drugs prescribed above the FDA-recommended maximum dose by age.

- Known or demonstrated hypersensitivity or intolerance to Dextromethorphan.

- Subjects taking a disallowed medication.

- For HIV-1 Infected Subjects Only: Presence of an active CDC Stage C (per 1994 Revised

Classification System for Human Immunodeficiency Virus Infection in Children Less Than 13 Years of Age, or 1993 Revised Classification System for HIV Infection Among Adolescents and Adults) opportunistic infection or serious bacterial infection requiring therapy within two weeks prior to screening.

Locations and Contacts

San Juan City Hosp. PR NICHD CRS (5031), San Juan 00927, Puerto Rico

Univ. of Alabama Birmingham NICHD CRS (5096), Birmingham, Alabama 35294, United States

Miller Children's Hospital Long Beach (5093), Long Beach, California 90806, United States

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601), Los Angeles, California 90095, United States

Usc La Nichd Crs (5048), Los Angeles, California 90033, United States

Univ of California, San Diego (UCSD) (4601), San Diego, California 92103, United States

Childrens Hospital (U. Colorado, Denver) NICHD CRS (5052), Denver, Colorado 80218-1088, United States

Children's National Med. Ctr. Washington DC NICHD CRS (5015), Washington, District of Columbia 20010, United States

South Florida CDC Ft Lauderdale NICHD CRS (5055), Ft Lauderdal, Florida 33316, United States

Univ of Miami Pediatric/Perinatal HIV/AIDS (4201), Miami, Florida 33136, United States

Chicago Children's CRS (4001), Chicago, Illinois 60611, United States

Rush University Cook County Hospital NICHD CRS (5083), Chicago, Illinois 60612, United States

Johns Hopkins University NICHD CRS (5092), Baltimore, Maryland 21287, United States

Boston Medical Center Ped. HIV Program NICHD CRS (5011), Boston, Massachusetts 02118, United States

WNE Maternal Pediatric Adolescent AIDS CRS (7301), Worcester, Massachusetts 01605, United States

Wayne State University/Children's Hospital of Michigan NICHD CRS (5041), Detroit, Michigan 48201, United States

Jacobi Med. Ctr. Bronx NICHD CRS (5013), Bronx, New York 10461, United States

Columbia IMPAACT Center (4101), New York, New York 10032, United States

New York University NY (5012), New York, New York 10016, United States

SUNY Stony Brook (5040), Stony Brook, New York 11794-8111, United States

St. Jude Childrens Research Hospital, Memphis (6501), Memphis, Tennessee 38105-2794, United States

Texas Children's Hosp. CRS (3801), Houston, Texas 77030, United States

Additional Information

Starting date: September 2010
Last updated: July 13, 2015

Page last updated: August 23, 2015

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