Status:
COMPLETED
Blood Levels of Abacavir in HIV Infected Adolescents
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
13-25 years
Phase:
NA
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 p...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00087945
Start Date
July 1 2004
End Date
December 1 2004
Last Update
October 8 2013
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Usc La Nichd Crs
Alhambra, California, United States, 91803
2
Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, United States, 90027
3
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States, 92103
4
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States, 20010