Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults
Data Collection
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: July 1, 2004
Actual date on which the first participant was enrolled.ABC is approved for the treatment of HIV in adults and children, but it is unclear if currently recommended ABC doses are appropriate for adolescents. Previous data suggest ABC clearance in children is about twice that found in adults, but limited data exist on the pharmacokinetics of ABC in adolescents. This study will evaluate the 8-hour pharmacokinetics of ABC in HIV infected adolescents who are currently on ABC-containing treatment regimens. There will be two groups in this study. Group 1 participants will be 13 to 17 years old. Group 2 participants will be 18 to 25 years old. All participants will receive a 300 mg dose of ABC as either a single-agent tablet or a combination tablet of ABC, lamivudine, and zidovudine (whichever they are currently taking). Participants will have a medical history assessment and a physical exam at screening and study entry. Participants will also be asked about adherence to their ABC-containing regimen at study entry. During the 8-hour drug level study, blood collection for pharmacokinetic analysis will occur prior to taking ABC, and at 0.5, 1, 2, 3, 4, 6, and 8 hours after taking ABC.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 13 to 25 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 20 locations
Children's Hospital of Los Angeles NICHD CRS
Los Angeles, United StatesUCSD Mother-Child-Adolescent Program CRS
San Diego, United StatesChildren's National Med. Ctr. Washington DC NICHD CRS
Washington, United States