Blood Levels of Abacavir in HIV Infected Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00087945
First received: July 16, 2004
Last updated: October 4, 2013
Last verified: October 2013
  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 Intervention
HIV Infections
Drug: Abacavir sulfate
Drug: Abacavir sulfate, lamivudine, and zidovudine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 30
Study Start Date: July 2004
Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   13 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087945

Locations
United States, California
Usc La Nichd Crs
Alhambra, California, United States, 91803
Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, United States, 90027
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States, 92103
United States, District of Columbia
Children's National Med. Ctr. Washington DC NICHD CRS
Washington, District of Columbia, United States, 20010
Children's National Med. Ctr., ACTU
Washington, District of Columbia, United States, 20010
United States, Florida
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
USF - Tampa NICHD CRS
Tampa, Florida, United States, 33606
United States, Georgia
Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Augusta, Georgia, United States, 30912
United States, Illinois
Chicago Children's CRS
Chicago, Illinois, United States, 60614
United States, Louisiana
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States, 01199
United States, Michigan
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States, 48201
United States, New Jersey
UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
New Brunswick, New Jersey, United States, 08901
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, United States, 07103
United States, New York
Bronx-Lebanon Hosp. IMPAACT CRS
Bronx, New York, United States, 10457
Columbia IMPAACT CRS
New York, New York, United States, 10032
United States, North Carolina
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
St. Jude/UTHSC CRS
Memphis, Tennessee, United States, 38105
Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Investigators
Study Chair: John Rodman, PharmD St. Jude's Children's Research Hospital
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00087945     History of Changes
Other Study ID Numbers: PACTG P1052, 10194
Study First Received: July 16, 2004
Last Updated: October 4, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Dideoxynucleosides
Lamivudine
Abacavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 01, 2014