Blood Levels of Abacavir After One Dose in HIV-Infected Children and Adolescents
Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents
4 other identifiers
interventional
24
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2002
CompletedNovember 1, 2021
October 1, 2021
February 22, 2001
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Children's Hospital of L.A. (Pediatric)
Los Angeles, California, 90054, United States
Univ of California, San Diego
San Diego, California, 92103, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
The Med Ctr Inc
Columbus, Georgia, 31901, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, 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
Univ of Rochester Med Ctr
Rochester, New York, 146420001, United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lawrence D'Angelo
- STUDY CHAIR
John Rodman
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2001
First Posted
August 31, 2001
Study Completion
August 1, 2002
Last Updated
November 1, 2021
Record last verified: 2021-10