Clinical trial NCT00087945: Blood Levels of Abacavir in HIV Infected Adolescents
Official title: Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Treatment Experienced
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2004-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Alhambra
country: United States
facility: Usc La Nichd Crs
state: California
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles NICHD CRS
state: California
city: San Diego
country: United States
facility: UCSD Mother-Child-Adolescent Program CRS
state: California
city: Washington
country: United States
facility: Children's National Med. Ctr. Washington DC NICHD CRS
state: District of Columbia
city: Washington
country: United States
facility: Children's National Med. Ctr., ACTU
state: District of Columbia
city: Jacksonville
country: United States
facility: Univ. of Florida Jacksonville NICHD CRS
state: Florida
city: Tampa
country: United States
facility: USF - Tampa NICHD CRS
state: Florida
city: Augusta
country: United States
facility: Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
state: Georgia
city: Chicago
country: United States
facility: Chicago Children's CRS
state: Illinois
city: New Orleans
country: United States
facility: Tulane/LSU Maternal/Child CRS
state: Louisiana
city: Boston
country: United States
facility: HMS - Children's Hosp. Boston, Div. of Infectious Diseases
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Health, Baystate Med. Ctr.
state: Massachusetts
city: Detroit
country: United States
facility: Children's Hospital of Michigan NICHD CRS
state: Michigan
city: New Brunswick
country: United States
facility: UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases
state: New Jersey
city: Newark
country: United States
facility: Rutgers - New Jersey Medical School CRS
state: New Jersey
city: Bronx
country: United States
facility: Bronx-Lebanon Hosp. IMPAACT CRS
state: New York
city: New York
country: United States
facility: Columbia IMPAACT CRS
state: New York
city: Chapel Hill
country: United States
facility: UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
state: North Carolina
city: Memphis
country: United States
facility: St. Jude/UTHSC CRS
state: Tennessee
city: San Juan
country: Puerto Rico
facility: San Juan City Hosp. PR NICHD CRS
Study officials:
affiliation: St. Jude's Children's Research Hospital
name: John Rodman, PharmD
role: STUDY_CHAIR
References:
citation: Chittick GE, Gillotin C, McDowell JA, Lou Y, Edwards KD, Prince WT, Stein DS. Abacavir: absolute bioavailability, bioequivalence of three oral formulations, and effect of food. Pharmacotherapy. 1999 Aug;19(8):932-42. doi: 10.1592/phco.19.11.932.31568.
citation: Hughes W, McDowell JA, Shenep J, Flynn P, Kline MW, Yogev R, Symonds W, Lou Y, Hetherington S. Safety and single-dose pharmacokinetics of abacavir (1592U89) in human immunodeficiency virus type 1-infected children. Antimicrob Agents Chemother. 1999 Mar;43(3):609-15. doi: 10.1128/AAC.43.3.609.
citation: Kline MW, Blanchard S, Fletcher CV, Shenep JL, McKinney RE Jr, Brundage RC, Culnane M, Van Dyke RB, Dankner WM, Kovacs A, McDowell JA, Hetherington S. A phase I study of abacavir (1592U89) alone and in combination with other antiretroviral agents in infants and children with human immunodeficiency virus infection. AIDS Clinical Trials Group 330 Team. Pediatrics. 1999 Apr;103(4):e47. doi: 10.1542/peds.103.4.e47.