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

This study has been completed.

First Received on February 22, 2001. Last Updated on August 7, 2008 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00011479

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Abacavir sulfate	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Primary Purpose: Treatment
Official Title:	Single Dose Pharmacokinetic Study of Abacavir in HIV-Infected Children and Adolescents

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Abacavir Abacavir succinate Abacavir sulfate

U.S. FDA Resources

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

Estimated Enrollment:

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

Ages Eligible for Study:	9 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011479

Show 24 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Study Chair:	Lawrence D'Angelo
Study Chair:	John Rodman

More Information

Additional Information:

Click here for more information about abacavir sulfate This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00011479 History of Changes
Other Study ID Numbers:	ACTG P1018, PACTG P1018
Study First Received:	February 22, 2001
Last Updated:	August 7, 2008
Health Authority:	United States: Federal Government

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

Administration, Oral
Drug Administration Schedule
Reverse Transcriptase Inhibitors

Anti-HIV Agents
Pharmacokinetics
abacavir

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

Reverse Transcriptase Inhibitors
Abacavir
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 12, 2012