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Clinical Trials

MainTitle

Blood Levels of Abacavir in HIV Infected 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
NCT00087945

First received: July 16, 2004
Last updated: October 4, 2013
Last Verified: October 2013
History of Changes
Purpose

Purpose

The way abacavir (ABC) behaves in the body differs between children and adults, but little is known about ABC in adolescents. It is unclear if adult doses of ABC are appropriate for adolescents. The purpose of this study is to determine the blood levels of ABC in HIV infected adolescents who are on ABC-containing regimens.

Condition Intervention
HIV Infections

Drug : Abacavir sulfate
Drug : Abacavir sulfate, lamivudine, and zidovudine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults

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

Enrollment: 30
Study Start Date: July 2004
Study Completion Date: December 2004

Detailed Description:

ABC is approved for the treatment of HIV in adults and children, but it is unclear if currently recommended ABC doses are appropriate for adolescents. Previous data suggest ABC clearance in children is about twice that found in adults, but limited data exist on the pharmacokinetics of ABC in adolescents. This study will evaluate the 8-hour pharmacokinetics of ABC in HIV infected adolescents who are currently on ABC-containing treatment regimens.
There will be two groups in this study. Group 1 participants will be 13 to 17 years old. Group 2 participants will be 18 to 25 years old. All participants will receive a 300 mg dose of ABC as either a single-agent tablet or a combination tablet of ABC, lamivudine, and zidovudine (whichever they are currently taking). Participants will have a medical history assessment and a physical exam at screening and study entry. Participants will also be asked about adherence to their ABC-containing regimen at study entry. During the 8-hour drug level study, blood collection for pharmacokinetic analysis will occur prior to taking ABC, and at

    2, 3, 4, 6, and 8 hours after taking ABC.

    Eligibility

    Eligibility

    Ages Eligible for Study: 13 Years to 25 Years  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria:

    • HIV-1 infected
    • CD4 count greater than 100 cells/mm3
    • Viral load less than 100,000 copies/ml
    • Have taken an abacavir-containing regimen for at least 8 weeks prior to study entry
    • Weight more than 83 lbs (37.5 kg)
    • Ability and willingness to swallow study medications
    • Consent of parent or guardian, if applicable


    Exclusion Criteria:
    • Any Grade 3 or greater toxicity within 14 days prior to study entry
    • Participation in PACTG P1018
    • CDC Category C opportunistic infections or HIV-1 associated cancer requiring drug therapy at the time of study enrollment
    • Treatment with immune modulators, including interleukin-2 or intravenous gamma globulin, within 30 days of study entry
    • Received therapeutic vaccines or any HIV-1 vaccine given for primary prevention within 30 days of study entry
    • Surgical or medical problem affecting gastrointestinal motility or absorption (e.g., ileus, ulcerative colitis) or liver function
    • History of chronic alcohol use
    • Any clinically significant disease other than HIV-1 infection that, in the investigator's opinion, would represent an increased risk for the participant or compromise the outcome of the study
    • Chemotherapy for active cancer
    • Pregnancy or breastfeeding

    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: NCT00087945

    Locations

    United States, California
    Usc La Nichd Crs
    Alhambra, California, United States, 91803
    Children's Hospital of Los Angeles NICHD CRS
    Los Angeles, California, United States, 90027
    UCSD Mother-Child-Adolescent Program CRS
    San Diego, California, United States, 92103
    United States, District of Columbia
    Children's National Med. Ctr. Washington DC NICHD CRS
    Washington, District of Columbia, United States, 20010
    Children's National Med. Ctr., ACTU
    Washington, District of Columbia, United States, 20010
    United States, Florida
    Univ. of Florida Jacksonville NICHD CRS
    Jacksonville, Florida, United States, 32209
    USF - Tampa NICHD CRS
    Tampa, Florida, United States, 33606
    United States, Georgia
    Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
    Augusta, Georgia, United States, 30912
    United States, Illinois
    Chicago Children's CRS
    Chicago, Illinois, United States, 60614
    United States, Louisiana
    Tulane/LSU Maternal/Child CRS
    New Orleans, Louisiana, United States, 70112
    United States, Massachusetts
    HMS - Children's Hosp. Boston, Div. of Infectious Diseases
    Boston, Massachusetts, United States, 02115
    Baystate Health, Baystate Med. Ctr.
    Springfield, Massachusetts, United States, 01199
    United States, Michigan
    Children's Hospital of Michigan NICHD CRS
    Detroit, Michigan, United States, 48201
    United States, New Jersey
    UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
    New Brunswick, New Jersey, United States, 08901
    Rutgers - New Jersey Medical School CRS
    Newark, New Jersey, United States, 07103
    United States, New York
    Bronx-Lebanon Hosp. IMPAACT CRS
    Bronx, New York, United States, 10457
    Columbia IMPAACT CRS
    New York, New York, United States, 10032
    United States, North Carolina
    UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
    Chapel Hill, North Carolina, United States, 27599
    United States, Tennessee
    St. Jude/UTHSC CRS
    Memphis, Tennessee, United States, 38105
    Puerto Rico
    San Juan City Hosp. PR NICHD CRS
    San Juan, Puerto Rico, 00936

    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: John Rodman, PharmD St. Jude's Children's Research Hospital
    More Information

    More Information


    Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
    ClinicalTrials.gov Identifier: NCT00087945   History of Changes  
    Other Study ID Numbers: PACTG P1052  
      10194  
    Study First Received: July 16, 2004  
    Last Updated: October 4, 2013  

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

    Treatment Experienced

    Additional relevant MeSH terms:
    HIV Infections
    Lamivudine
    Zidovudine
    Abacavir
    Dideoxynucleosides

    ClinicalTrials.gov processed this data on October 16, 2017
    This information is provided by ClinicalTrials.gov.