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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Abacavir sulfate
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Administration, Oral, Drug Administration Schedule, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics, abacavir

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham - Pediatric
  • Los Angeles County - USC Med Ctr
  • Children's Hospital of L.A. (Pediatric)
  • Univ of California, San Diego
  • Children's Hosp of Washington DC
  • Univ of Florida Health Science Ctr / Pediatrics
  • Univ of Miami (Pediatric)
  • Med College of Georgia
  • The Med Ctr Inc
  • Cook County Hosp
  • Chicago Children's Memorial Hosp
  • Univ of Chicago Children's Hosp
  • Children's Hosp of Boston
  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
  • Montefiore Med Ctr Adolescent AIDS Program
  • Metropolitan Hosp Ctr
  • Univ of Rochester Med Ctr
  • State Univ of New York at Stony Brook
  • Duke Univ Med Ctr
  • Columbus Children's Hosp
  • Med Univ of South Carolina
  • Saint Jude Children's Research Hosp of Memphis
  • Children's Med Ctr of Dallas
  • Texas Children's Hosp / Baylor Univ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 22, 2001
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00011479
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Administration, Oral, Drug Administration Schedule, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics, abacavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence D'Angelo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John Rodman
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham - Pediatric
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Children's Hospital of L.A. (Pediatric)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90054
Country
United States
Facility Name
Univ of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Children's Hosp of Washington DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200102916
Country
United States
Facility Name
Univ of Florida Health Science Ctr / Pediatrics
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ of Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
The Med Ctr Inc
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Univ of Chicago Children's Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032714
Country
United States
Facility Name
Montefiore Med Ctr Adolescent AIDS Program
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Metropolitan Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
146420001
Country
United States
Facility Name
State Univ of New York at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948111
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
Facility Name
Columbus Children's Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432052696
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
294253312
Country
United States
Facility Name
Saint Jude Children's Research Hosp of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
381052794
Country
United States
Facility Name
Children's Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Children's Hosp / Baylor Univ
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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