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Trial NCT00011479

Resource URI: http://static.linkedct.org/resource/trials/NCT00011479
PropertyValue
linkedct:brief_title Blood Levels of Abacavir After One Dose in HIV-Infected Children and Adolescents
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/2560>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct: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.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 18 Years
linkedct:eligibility_minimum_age 9 Years
linkedct:enrollment 24 (xsd:int)
linkedct:firstreceived_date February 22, 2001
linkedct:id NCT00011479
rdfs:label Trial NCT00011479
linkedct:lastchanged_date August 7, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/147780>
linkedct:location <http://static.linkedct.org/resource/location/151107>
linkedct:location <http://static.linkedct.org/resource/location/153748>
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linkedct:location <http://static.linkedct.org/resource/location/155960>
linkedct:location <http://static.linkedct.org/resource/location/157412>
linkedct:location <http://static.linkedct.org/resource/location/161675>
linkedct:location <http://static.linkedct.org/resource/location/167197>
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linkedct:location <http://static.linkedct.org/resource/location/171044>
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linkedct:location <http://static.linkedct.org/resource/location/171716>
linkedct:location <http://static.linkedct.org/resource/location/174045>
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linkedct:location <http://static.linkedct.org/resource/location/179912>
linkedct:location <http://static.linkedct.org/resource/location/181624>
linkedct:location <http://static.linkedct.org/resource/location/192654>
linkedct:location <http://static.linkedct.org/resource/location/192981>
linkedct:location <http://static.linkedct.org/resource/location/193168>
linkedct:location <http://static.linkedct.org/resource/location/200256>
linkedct:location <http://static.linkedct.org/resource/location/202102>
linkedct:location <http://static.linkedct.org/resource/location/210066>
linkedct:location <http://static.linkedct.org/resource/location/210434>
linkedct:location <http://static.linkedct.org/resource/location/213413>
linkedct:nct_id NCT00011479
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents
linkedct:org_study_id ACTG P1018
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/29377>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/34512>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00011479>
linkedct:phase Phase 1
linkedct:secondary_id PACTG P1018
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date July 2004