Blood Levels of Abacavir in HIV Infected Adolescents
This study is currently recruiting patients.
Purpose
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.
| Condition
|
Treatment or Intervention |
HIV Infections
|
Drug: Abacavir sulfate
Drug: Abacavir sulfate, lamivudine, and zidovudine
|
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title: Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults
Further Study Details:
Expected Total Enrollment:
30
ABC is approved for the treatment of HIV in adults and children, but it is unclear if currently recommended ABC doses are
appropriate for adolescents. Previous data suggest ABC clearance in children is about twice that found in adults, but limited
data exist on the pharmacokinetics of ABC in adolescents. This study will evaluate the 8-hour pharmacokinetics of ABC in HIV
infected adolescents who are currently on ABC-containing treatment regimens.
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.
Eligibility
Ages Eligible for Study:
13 Years
-
25 Years,
Genders Eligible for Study:
Both
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Location
and Contact
Information
California UCSD Mother, Child & Adolescent HIV Program, San Diego,
California,
92103,
United States; Recruiting
Los Angeles County Medical Center/USC, Los Angeles,
California,
90033,
United States; Recruiting
Florida University of South Flordia, St. Petersburg,
Florida,
33701,
United States; Recruiting
Georgia Medical College of Georgia, Augusta,
Georgia,
30912,
United States; Recruiting
Illinois Chicago Childrens Memorial Hospital (Pediatric), Chicago,
Illinois,
60614,
United States; Recruiting
Louisiana Tulane Univ., Charity Hospital of New Orleans, New Orleans,
Louisiana,
70112-2699,
United States; Recruiting
Massachusetts Baystate Medical Center, Springfield, Springfield,
Massachusetts,
01199,
United States; Recruiting
Michigan Childrens Hospital of Michigan, Detroit,
Michigan,
48201,
United States; Recruiting
New Jersey Univ. of Med. & Dentistry of NJ/Univ. Hospital, Newark,
New Jersey,
07101-1709,
United States; Recruiting
Robert Wood Johnson AIDS Program, New Brunswick,
New Jersey,
08901-1969,
United States; Recruiting
New York Bronx Lebanon Hospital Center, Bronx,
New York,
10457,
United States; Recruiting
Tennessee St. Jude Childrens Research Hospital, Memphis, Memphis,
Tennessee,
38105-2794,
United States; Recruiting
Study chairs or principal investigators
John Rodman, PharmD, Study Chair, St. Jude's Children's Research Hospital
More Information
Click here for more information about abacavir sulfate
Click here for more information about abacavir sulfate, lamivudine, and zidovudine
Publications
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.
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.
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.
Study ID Numbers:
PACTG P1052
Record last reviewed:
October 2004
Record first received:
July 16, 2004
ClinicalTrials.gov Identifier:
NCT00087945Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08
