search
Back to results

Blood Levels of Abacavir in HIV Infected Adolescents

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Abacavir sulfate
Abacavir sulfate, lamivudine, and zidovudine
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 Treatment Experienced

Eligibility Criteria

13 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Usc La Nichd Crs
  • Children's Hospital of Los Angeles NICHD CRS
  • UCSD Mother-Child-Adolescent Program CRS
  • Children's National Med. Ctr. Washington DC NICHD CRS
  • Children's National Med. Ctr., ACTU
  • Univ. of Florida Jacksonville NICHD CRS
  • USF - Tampa NICHD CRS
  • Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
  • Chicago Children's CRS
  • Tulane/LSU Maternal/Child CRS
  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  • Baystate Health, Baystate Med. Ctr.
  • Children's Hospital of Michigan NICHD CRS
  • UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
  • Rutgers - New Jersey Medical School CRS
  • Bronx-Lebanon Hosp. IMPAACT CRS
  • Columbia IMPAACT CRS
  • UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
  • St. Jude/UTHSC CRS
  • San Juan City Hosp. PR NICHD CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 16, 2004
Last Updated
October 4, 2013
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT00087945
Brief Title
Blood Levels of Abacavir in HIV Infected Adolescents
Official Title
Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (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 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate, lamivudine, and zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Rodman, PharmD
Organizational Affiliation
St. Jude's Children's Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Usc La Nichd Crs
City
Alhambra
State/Province
California
ZIP/Postal Code
91803
Country
United States
Facility Name
Children's Hospital of Los Angeles NICHD CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
UCSD Mother-Child-Adolescent Program CRS
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Children's National Med. Ctr. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Children's National Med. Ctr., ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
USF - Tampa NICHD CRS
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Baystate Health, Baystate Med. Ctr.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Children's Hospital of Michigan NICHD CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Rutgers - New Jersey Medical School CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Bronx-Lebanon Hosp. IMPAACT CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Columbia IMPAACT CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
St. Jude/UTHSC CRS
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
10453964
Citation
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. doi: 10.1592/phco.19.11.932.31568.
Results Reference
background
PubMed Identifier
10049275
Citation
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. doi: 10.1128/AAC.43.3.609.
Results Reference
background
PubMed Identifier
10103339
Citation
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. doi: 10.1542/peds.103.4.e47.
Results Reference
background

Learn more about this trial

Blood Levels of Abacavir in HIV Infected Adolescents

We'll reach out to this number within 24 hrs