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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00011479

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

24

Expected to finish

2002-08-01

Last updated by the study team

2021-11-01

Who can join

Age: 9 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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