Overview
Blood Levels of Abacavir in HIV Infected Adolescents
Status:
Completed
Completed
Trial end date:
2004-12-01
2004-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
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
Lamivudine
Zidovudine
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