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NCT00087945 Clinical Trial

Blood Levels of Abacavir in HIV Infected Adolescents

HIV Infections Clinical Trial

Official title:
Abacavir Pharmacokinetics During Chronic Therapy in HIV-1 Infected Adolescents and Young Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00087945
Other study ID # PACTG P1052
Secondary ID 10194
Status Completed
Phase N/A
First received July 16, 2004
Last updated October 4, 2013
Start date July 2004
Est. completion date December 2004

Study information
Verified date October 2013
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 25 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Abacavir sulfate

• Abacavir sulfate, lamivudine, and zidovudine

Locations
Country Name City State
Puerto Rico San Juan City Hosp. PR NICHD CRS San Juan
United States Usc La Nichd Crs Alhambra California
United States Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases Augusta Georgia
United States HMS - Children's Hosp. Boston, Div. of Infectious Diseases Boston Massachusetts
United States Bronx-Lebanon Hosp. IMPAACT CRS Bronx New York
United States UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases Chapel Hill North Carolina
United States Chicago Children's CRS Chicago Illinois
United States Children's Hospital of Michigan NICHD CRS Detroit Michigan
United States Univ. of Florida Jacksonville NICHD CRS Jacksonville Florida
United States Children's Hospital of Los Angeles NICHD CRS Los Angeles California
United States St. Jude/UTHSC CRS Memphis Tennessee
United States UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases New Brunswick New Jersey
United States Tulane/LSU Maternal/Child CRS New Orleans Louisiana
United States Columbia IMPAACT CRS New York New York
United States Rutgers - New Jersey Medical School CRS Newark New Jersey
United States UCSD Mother-Child-Adolescent Program CRS San Diego California
United States Baystate Health, Baystate Med. Ctr. Springfield Massachusetts
United States USF - Tampa NICHD CRS Tampa Florida
United States Children's National Med. Ctr. Washington DC NICHD CRS Washington District of Columbia
United States Children's National Med. Ctr., ACTU Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

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