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Home > "B" Clinical Trials Conditions > Blood Levels of Abacavir after One Dose in HIV-Infected Children and Adolescents  Blood Levels of Abacavir after One Dose in HIV-Infected Children and Adolescents
Blood Levels of Abacavir after One Dose in HIV-Infected Children and Adolescents
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 9 Years/18 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
LawrenceD'Angelo, Study Chair,
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
The Med Ctr Inc
Columbus, Georgia, 31901
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
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 Med Ctr of Dallas
Dallas, Texas, 75235
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Children's Hospital of L.A. (Pediatric)
Los Angeles, California, 90054
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
Additional Information:
Study ID Numbers: ACTG P1018; PACTG P1018
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00011479
Other Hiv Infections Studies:
1. Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
2. Dexamethasone in Cryptococcal Meningitis
3. Fortovase (Saquinavir) Given with Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns
4. HIV Prevention Preparedness Study in Russia, China, and India
5. Roll-over Trial Only for HIV-1 Infected Subjects in Control Groups of Selected TMC114 Trials who Fail Treatment
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Blood Levels of Abacavir after One Dose in HIV-Infected Children and Adolescents
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