Blood Levels of Abacavir in HIV Infected Adolescents
Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults
2 other identifiers
interventional
30
2 countries
20
Brief Summary
The way abacavir (ABC) behaves in the body differs between children and adults, but little is known about ABC in adolescents. It is unclear if adult doses of ABC are appropriate for adolescents. The purpose of this study is to determine the blood levels of ABC in HIV infected adolescents who are on ABC-containing regimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
Started Jul 2004
Shorter than P25 for not_applicable hiv-infections
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 16, 2004
CompletedFirst Posted
Study publicly available on registry
July 19, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedOctober 8, 2013
October 1, 2013
July 16, 2004
October 4, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- HIV-1 infected
- CD4 count greater than 100 cells/mm3
- Viral load less than 100,000 copies/ml
- Have taken an abacavir-containing regimen for at least 8 weeks prior to study entry
- Weight more than 83 lbs (37.5 kg)
- Ability and willingness to swallow study medications
- Consent of parent or guardian, if applicable
You may not qualify if:
- Any Grade 3 or greater toxicity within 14 days prior to study entry
- Participation in PACTG P1018
- CDC Category C opportunistic infections or HIV-1 associated cancer requiring drug therapy at the time of study enrollment
- Treatment with immune modulators, including interleukin-2 or intravenous gamma globulin, within 30 days of study entry
- Received therapeutic vaccines or any HIV-1 vaccine given for primary prevention within 30 days of study entry
- Surgical or medical problem affecting gastrointestinal motility or absorption (e.g., ileus, ulcerative colitis) or liver function
- History of chronic alcohol use
- Any clinically significant disease other than HIV-1 infection that, in the investigator's opinion, would represent an increased risk for the participant or compromise the outcome of the study
- Chemotherapy for active cancer
- Pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Usc La Nichd Crs
Alhambra, California, 91803, United States
Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, 90027, United States
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, 92103, United States
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20010, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, 20010, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209, United States
USF - Tampa NICHD CRS
Tampa, Florida, 33606, United States
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Augusta, Georgia, 30912, United States
Chicago Children's CRS
Chicago, Illinois, 60614, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 02115, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, 48201, United States
UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
New Brunswick, New Jersey, 08901, United States
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, 07103, United States
Columbia IMPAACT CRS
New York, New York, 10032, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, 27599, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, 38105, United States
San Juan City Hosp. PR NICHD CRS
San Juan, 00936, Puerto Rico
Related Publications (3)
Chittick GE, Gillotin C, McDowell JA, Lou Y, Edwards KD, Prince WT, Stein DS. Abacavir: absolute bioavailability, bioequivalence of three oral formulations, and effect of food. Pharmacotherapy. 1999 Aug;19(8):932-42. doi: 10.1592/phco.19.11.932.31568.
PMID: 10453964BACKGROUNDHughes W, McDowell JA, Shenep J, Flynn P, Kline MW, Yogev R, Symonds W, Lou Y, Hetherington S. Safety and single-dose pharmacokinetics of abacavir (1592U89) in human immunodeficiency virus type 1-infected children. Antimicrob Agents Chemother. 1999 Mar;43(3):609-15. doi: 10.1128/AAC.43.3.609.
PMID: 10049275BACKGROUNDKline MW, Blanchard S, Fletcher CV, Shenep JL, McKinney RE Jr, Brundage RC, Culnane M, Van Dyke RB, Dankner WM, Kovacs A, McDowell JA, Hetherington S. A phase I study of abacavir (1592U89) alone and in combination with other antiretroviral agents in infants and children with human immunodeficiency virus infection. AIDS Clinical Trials Group 330 Team. Pediatrics. 1999 Apr;103(4):e47. doi: 10.1542/peds.103.4.e47.
PMID: 10103339BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John Rodman, PharmD
St. Jude's Children's Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2004
First Posted
July 19, 2004
Study Start
July 1, 2004
Study Completion
December 1, 2004
Last Updated
October 8, 2013
Record last verified: 2013-10