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
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COMPLETED
NA
30 participants
INTERVENTIONAL
2004-07-31
2004-12-31
Brief Summary
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Detailed Description
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There will be two groups in this study. Group 1 participants will be 13 to 17 years old. Group 2 participants will be 18 to 25 years old. All participants will receive a 300 mg dose of ABC as either a single-agent tablet or a combination tablet of ABC, lamivudine, and zidovudine (whichever they are currently taking). Participants will have a medical history assessment and a physical exam at screening and study entry. Participants will also be asked about adherence to their ABC-containing regimen at study entry. During the 8-hour drug level study, blood collection for pharmacokinetic analysis will occur prior to taking ABC, and at 0.5, 1, 2, 3, 4, 6, and 8 hours after taking ABC.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Abacavir sulfate
Abacavir sulfate, lamivudine, and zidovudine
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
13 Years
25 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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John Rodman, PharmD
Role: STUDY_CHAIR
St. Jude's Children's Research Hospital
Locations
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Usc La Nichd Crs
Alhambra, California, United States
Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, United States
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States
USF - Tampa NICHD CRS
Tampa, Florida, United States
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Augusta, Georgia, United States
Chicago Children's CRS
Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States
UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
New Brunswick, New Jersey, United States
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, United States
Columbia IMPAACT CRS
New York, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, United States
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Countries
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References
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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.
Hughes 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.
Kline 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.
Other Identifiers
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10194
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG P1052
Identifier Type: -
Identifier Source: org_study_id