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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00011479
• Other study ID #: P1018
• Secondary ID: 11653ACTG P1018P
• Status: Completed
• Phase: Phase 1
• Est. completion date: August 2002

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Abacavir sulfate

Locations

Country	Name	City	State
United States	Med College of Georgia	Augusta	Georgia
United States	Univ of Alabama at Birmingham - Pediatric	Birmingham	Alabama
United States	Children's Hosp of Boston	Boston	Massachusetts
United States	Montefiore Med Ctr Adolescent AIDS Program	Bronx	New York
United States	Med Univ of South Carolina	Charleston	South Carolina
United States	Chicago Children's Memorial Hosp	Chicago	Illinois
United States	Cook County Hosp	Chicago	Illinois
United States	Univ of Chicago Children's Hosp	Chicago	Illinois
United States	Columbus Children's Hosp	Columbus	Ohio
United States	The Med Ctr Inc	Columbus	Georgia
United States	Children's Med Ctr of Dallas	Dallas	Texas
United States	Duke Univ Med Ctr	Durham	North Carolina
United States	Texas Children's Hosp / Baylor Univ	Houston	Texas
United States	Univ of Florida Health Science Ctr / Pediatrics	Jacksonville	Florida
United States	Children's Hospital of L.A. (Pediatric)	Los Angeles	California
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Saint Jude Children's Research Hosp of Memphis	Memphis	Tennessee
United States	Univ of Miami (Pediatric)	Miami	Florida
United States	Metropolitan Hosp Ctr	New York	New York
United States	Univ of Medicine & Dentistry of New Jersey / Univ Hosp	Newark	New Jersey
United States	Univ of Rochester Med Ctr	Rochester	New York
United States	Univ of California, San Diego	San Diego	California
United States	State Univ of New York at Stony Brook	Stony Brook	New York
United States	Children's Hosp of Washington DC	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

External Links

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