Clinical trial NCT00011479: Blood Levels of Abacavir After One Dose in HIV-Infected Children and Adolescents
Official title: Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Administration, Oral
Drug Administration Schedule
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Pharmacokinetics
abacavir
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2001-08-31
Enrollment: 24
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham - Pediatric
state: Alabama
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: Los Angeles
country: United States
facility: Children's Hospital of L.A. (Pediatric)
state: California
city: San Diego
country: United States
facility: Univ of California, San Diego
state: California
city: Washington
country: United States
facility: Children's Hosp of Washington DC
state: District of Columbia
city: Jacksonville
country: United States
facility: Univ of Florida Health Science Ctr / Pediatrics
state: Florida
city: Miami
country: United States
facility: Univ of Miami (Pediatric)
state: Florida
city: Augusta
country: United States
facility: Med College of Georgia
state: Georgia
city: Columbus
country: United States
facility: The Med Ctr Inc
state: Georgia
city: Chicago
country: United States
facility: Cook County Hosp
state: Illinois
city: Chicago
country: United States
facility: Chicago Children's Memorial Hosp
state: Illinois
city: Chicago
country: United States
facility: Univ of Chicago Children's Hosp
state: Illinois
city: Boston
country: United States
facility: Children's Hosp of Boston
state: Massachusetts
city: Newark
country: United States
facility: Univ of Medicine & Dentistry of New Jersey / Univ Hosp
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Med Ctr Adolescent AIDS Program
state: New York
city: New York
country: United States
facility: Metropolitan Hosp Ctr
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
city: Stony Brook
country: United States
facility: State Univ of New York at Stony Brook
state: New York
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Columbus
country: United States
facility: Columbus Children's Hosp
state: Ohio
city: Charleston
country: United States
facility: Med Univ of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Saint Jude Children's Research Hosp of Memphis
state: Tennessee
city: Dallas
country: United States
facility: Children's Med Ctr of Dallas
state: Texas
city: Houston
country: United States
facility: Texas Children's Hosp / Baylor Univ
state: Texas
Study officials:
name: Lawrence D'Angelo
role: STUDY_CHAIR
name: John Rodman
role: STUDY_CHAIR
References: