Blood Levels of Abacavir After One Dose in HIV-Infected Children and Adolescents

Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Abacavir sulfate

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.

• Study Type: Interventional
• Enrollment: 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Univ of Alabama at Birmingham - Pediatric
  • California
    • Los Angeles, California, United States, 90033
      • Los Angeles County - USC Med Ctr
    • Los Angeles, California, United States, 90054
      • Children's Hospital of L.A. (Pediatric)
    • San Diego, California, United States, 92103
      • Univ of California, San Diego
  • District of Columbia
    • Washington, District of Columbia, United States, 200102916
      • Children's Hosp of Washington DC
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Univ of Florida Health Science Ctr / Pediatrics
    • Miami, Florida, United States, 33161
      • Univ of Miami (Pediatric)
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Med College of Georgia
    • Columbus, Georgia, United States, 31901
      • The Med Ctr Inc
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Cook County Hosp
    • Chicago, Illinois, United States, 606143394
      • Chicago Children's Memorial Hosp
    • Chicago, Illinois, United States, 606371470
      • Univ of Chicago Children's Hosp
  • Massachusetts
    • Boston, Massachusetts, United States, 021155724
      • Children's Hosp of Boston
  • New Jersey
    • Newark, New Jersey, United States, 071032714
      • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Med Ctr Adolescent AIDS Program
    • New York, New York, United States, 10029
      • Metropolitan Hosp Ctr
    • Rochester, New York, United States, 146420001
      • Univ of Rochester Med Ctr
    • Stony Brook, New York, United States, 117948111
      • State Univ of New York at Stony Brook
  • North Carolina
    • Durham, North Carolina, United States, 277103499
      • Duke Univ Med Ctr
  • Ohio
    • Columbus, Ohio, United States, 432052696
      • Columbus Children's Hosp
  • South Carolina
    • Charleston, South Carolina, United States, 294253312
      • Med Univ of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 381052794
      • Saint Jude Children's Research Hosp of Memphis
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Med Ctr of Dallas
    • Houston, Texas, United States, 77030
      • Texas Children's Hosp / Baylor Univ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Study Chair: Lawrence D'Angelo; Study Chair: John Rodman

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion (Actual): August 1, 2002

Study Registration Dates

• First Submitted: February 22, 2001
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Reverse Transcriptase Inhibitors; Anti-HIV Agents; Pharmacokinetics; Drug Administration Schedule; abacavir; Administration, Oral
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Abacavir
• Other Study ID Numbers: P1018; 11653 (Registry Identifier: DAIDS ES); ACTG P1018; PACTG P1018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No