Blood Levels of Abacavir After One Dose in HIV-Infected Children and Adolescents
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Abacavir sulfate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Lawrence D'Angelo, Study Chair
John Rodman, Study Chair
Summary
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.
Clinical Details
Official title: Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents
Study design: Treatment, Pharmacokinetics Study
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,
2. 0, 2. 5, 3. 0, 4, 6, and 8 hours post dose for abacavir concentrations.
Eligibility
Minimum age: 9 Years.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Univ of Alabama at Birmingham - Pediatric, Birmingham, Alabama 35233, United States
Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States
Univ of California, San Diego, San Diego, California 92103, United States
Children's Hospital of L.A. (Pediatric), Los Angeles, California 90054, United States
Children's Hosp of Washington DC, Washington, District of Columbia 200102916, United States
Univ of Miami (Pediatric), Miami, Florida 33161, United States
Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida 32209, United States
Med College of Georgia, Augusta, Georgia 30912, United States
The Med Ctr Inc, Columbus, Georgia 31901, United States
Chicago Children's Memorial Hosp, Chicago, Illinois 606143394, United States
Cook County Hosp, Chicago, Illinois 60612, United States
Univ of Chicago Children's Hosp, Chicago, Illinois 606371470, United States
Children's Hosp of Boston, Boston, Massachusetts 021155724, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey 071032714, United States
Metropolitan Hosp Ctr, New York, New York 10029, United States
State Univ of New York at Stony Brook, Stony Brook, New York 117948111, United States
Montefiore Med Ctr Adolescent AIDS Program, Bronx, New York 10467, United States
Univ of Rochester Med Ctr, Rochester, New York 146420001, United States
Duke Univ Med Ctr, Durham, North Carolina 277103499, United States
Columbus Children's Hosp, Columbus, Ohio 432052696, United States
Med Univ of South Carolina, Charleston, South Carolina 294253312, United States
Saint Jude Children's Research Hosp of Memphis, Memphis, Tennessee 381052794, United States
Children's Med Ctr of Dallas, Dallas, Texas 75235, United States
Texas Children's Hosp / Baylor Univ, Houston, Texas 77030, United States
Additional Information
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Last updated: June 23, 2005
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