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

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Abacavir; Dideoxynucleosides

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.