Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents
Blood Levels of Abacavir After One Dose in HIV-Infected Children and Adolescents
Sponsors
Source
National Institute of Allergy and Infectious Diseases (NIAID)
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.
Detailed 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.
Overall Status
Completed
Start Date
N/A
Completion Date
2002-08-01
Primary Completion Date
N/A
Phase
Phase 1
Study Type
Interventional
Enrollment
24
Condition
Intervention
Eligibility
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.
Gender
All
Minimum Age
9 Years
Maximum Age
18 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
|
Lawrence D'Angelo |
Study Chair |
|
John Rodman |
Study Chair |
Location
Facility |
|
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 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 |
|
Montefiore Med Ctr Adolescent AIDS Program Bronx New York 10467 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 |
|
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 |
Location Countries
Country
United States
Verification Date
2012-05-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
11653
ACTG P1018
PACTG P1018
Intervention Browse
Mesh Term
Abacavir
Dideoxynucleosides
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Primary Purpose
Treatment
Study First Submitted
February 22, 2001
Study First Submitted Qc
August 30, 2001
Study First Posted
August 31, 2001
Last Update Submitted
May 17, 2012
Last Update Submitted Qc
May 17, 2012
Last Update Posted
May 21, 2012
ClinicalTrials.gov processed this data on December 10, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.