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Clinical Trials

MainTitle

Blood Levels of Abacavir After One Dose in HIV-Infected Children and Adolescents

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00011479

First received: February 22, 2001
Last updated: May 17, 2012
Last Verified: May 2012
History of Changes
Purpose

Purpose

The purpose of this study is to measure blood levels of abacavir in children and adolescents over a period of time following a single dose so that a dosage for adolescents can be determined.

Little is known about how abacavir is cleared by the body in adolescents. It has been shown that young children require a higher abacavir dose based on weight than adults. Older children, or adolescents, may not require as high a dose. This study may provide information as to whether the children's dose or the adult dose is better for HIV-infected adolescents.

Condition Intervention Phase
HIV Infections

Drug : Abacavir sulfate
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 24
Study Completion Date: August 2002

Detailed Description:

Pharmacokinetic differences between children and adults have resulted in recommended doses of abacavir based on weight that are higher for children than for adults. There are insufficient data to determine whether the pediatric or adult dose is more appropriate for HIV-infected adolescent patients. This study measures pharmacokinetic data for abacavir in the adolescent population so that an appropriate dosage can be determined.
Patients are evenly enrolled into 2 groups based on Tanner Stage. Group I patients are Tanner Stage 1 or 2 (pre-pubertal). Group II patients are Tanner Stage 3, 4, or 5 (pubertal). Each patient receives a single oral dose of abacavir given as the commercially available oral solution. Pharmacokinetic blood samples are collected before dosing and at 0.5, 1.0, 1.5,

    5, 3.0, 4, 6, and 8 hours post dose for abacavir concentrations.

    Eligibility

    Eligibility

    Ages Eligible for Study: 9 Years to 18 Years  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria
    Patients may be eligible for this study if they:

    • Are 9 to 18 years of age.
    • Are HIV-positive.
    • Have a CD4 cell count above 200 cells/microL.
    • Have a viral load (level of HIV in the blood) under 100,000 copies/ml.
    • Have not changed their anti-HIV drugs for the 4 weeks before study entry.
    • Are able to swallow study medications.
    • Both males and females, agree to use a barrier method of birth control for 3 days after taking the abacavir dose for this study. (This study has been changed. In the earlier version, no birth control was needed.)
    • Can be followed at a participating Pediatric AIDS Clinical Trials Unit (PACTU) for the entire study.
    • Provide written consent of a parent or guardian, if under 18 years of age.

    • Exclusion Criteria
      Patients will not be eligible for this study if they:
    • Have liver or kidney problems, as shown by screening tests.
    • Have medical or surgical problems that affect movement or absorption in the stomach or gut.
    • Have an opportunistic (AIDS-related) or serious bacterial infection requiring medicine at the time of enrollment.
    • Have any diseases (other than HIV infection) or other findings that, in the investigator's opinion, might make it harmful for the patient to be on the study.
    • Have a history of chronic alcohol use.
    • Fall outside of a certain weight range for their age.
    • Are pregnant or breast-feeding.
    • Are receiving or have received abacavir.
    • Are receiving nonnucleoside reverse transcriptase inhibitors, including efavirenz, delavirdine, or nevirapine; hydroxyurea; mycophenylate; rifampin, rifabutin, anticonvulsants, or other drugs that affect the liver; or chemotherapy for active cancer.
    • Have received interferons, interleukins, HIV or other vaccines, or experimental
    therapy within 30 days before entering the study.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00011479

    Locations

    United States, Alabama
    Univ of Alabama at Birmingham - Pediatric
    Birmingham, Alabama, United States, 35233
    United States, California
    Los Angeles County - USC Med Ctr
    Los Angeles, California, United States, 90033
    Children's Hospital of L.A. (Pediatric)
    Los Angeles, California, United States, 90054
    Univ of California, San Diego
    San Diego, California, United States, 92103
    United States, District of Columbia
    Children's Hosp of Washington DC
    Washington, District of Columbia, United States, 200102916
    United States, Florida
    Univ of Florida Health Science Ctr / Pediatrics
    Jacksonville, Florida, United States, 32209
    Univ of Miami (Pediatric)
    Miami, Florida, United States, 33161
    United States, Georgia
    Med College of Georgia
    Augusta, Georgia, United States, 30912
    The Med Ctr Inc
    Columbus, Georgia, United States, 31901
    United States, Illinois
    Cook County Hosp
    Chicago, Illinois, United States, 60612
    Chicago Children's Memorial Hosp
    Chicago, Illinois, United States, 606143394
    Univ of Chicago Children's Hosp
    Chicago, Illinois, United States, 606371470
    United States, Massachusetts
    Children's Hosp of Boston
    Boston, Massachusetts, United States, 021155724
    United States, New Jersey
    Univ of Medicine & Dentistry of New Jersey / Univ Hosp
    Newark, New Jersey, United States, 071032714
    United States, New York
    Montefiore Med Ctr Adolescent AIDS Program
    Bronx, New York, United States, 10467
    Metropolitan Hosp Ctr
    New York, New York, United States, 10029
    Univ of Rochester Med Ctr
    Rochester, New York, United States, 146420001
    State Univ of New York at Stony Brook
    Stony Brook, New York, United States, 117948111
    United States, North Carolina
    Duke Univ Med Ctr
    Durham, North Carolina, United States, 277103499
    United States, Ohio
    Columbus Children's Hosp
    Columbus, Ohio, United States, 432052696
    United States, South Carolina
    Med Univ of South Carolina
    Charleston, South Carolina, United States, 294253312
    United States, Tennessee
    Saint Jude Children's Research Hosp of Memphis
    Memphis, Tennessee, United States, 381052794
    United States, Texas
    Children's Med Ctr of Dallas
    Dallas, Texas, United States, 75235
    Texas Children's Hosp / Baylor Univ
    Houston, Texas, United States, 77030

    Sponsors and Collaborators

    National Institute of Allergy and Infectious Diseases (NIAID)
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    Study Chair: Lawrence D'Angelo
    Study Chair: John Rodman
    More Information

    More Information


    Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
    ClinicalTrials.gov Identifier: NCT00011479   History of Changes  
    Other Study ID Numbers: P1018  
      11653  
      ACTG P1018  
      PACTG P1018  
    Study First Received: February 22, 2001  
    Last Updated: May 17, 2012  

    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

    Administration, Oral
    Drug Administration Schedule
    Reverse Transcriptase Inhibitors
    Anti-HIV Agents
    Pharmacokinetics
    abacavir

    Additional relevant MeSH terms:
    HIV Infections
    Abacavir
    Dideoxynucleosides

    ClinicalTrials.gov processed this data on October 20, 2017
    This information is provided by ClinicalTrials.gov.