Blood Levels of Abacavir in HIV Infected Adolescents

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00087945

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

30

Starts

2004-07-01

Expected to finish

2004-12-01

Last updated by the study team

2013-10-08

Who can join

Age: 13 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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