Blood Levels of Abacavir After One Dose in HIV-Infected Children and Adolescents
NCT ID: NCT00011479
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2002-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abacavir sulfate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
9 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lawrence D'Angelo
Role: STUDY_CHAIR
John Rodman
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Children's Hospital of L.A. (Pediatric)
Los Angeles, California, United States
Univ of California, San Diego
San Diego, California, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Med College of Georgia
Augusta, Georgia, United States
The Med Ctr Inc
Columbus, Georgia, United States
Cook County Hosp
Chicago, Illinois, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Metropolitan Hosp Ctr
New York, New York, United States
Univ of Rochester Med Ctr
Rochester, New York, United States
State Univ of New York at Stony Brook
Stony Brook, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Columbus Children's Hosp
Columbus, Ohio, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
Children's Med Ctr of Dallas
Dallas, Texas, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11653
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG P1018
Identifier Type: -
Identifier Source: secondary_id
PACTG P1018
Identifier Type: -
Identifier Source: secondary_id
P1018
Identifier Type: -
Identifier Source: org_study_id