Status:
COMPLETED
Effect of Medication Diaries on Adherence to Highly Active Antiretroviral Drugs Among HIV-1 Infected Kenyan Children
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
HIV Infections
Eligibility:
All Genders
18-12 years
Phase:
PHASE2
Brief Summary
Following significant reduction in antiretroviral drug prices over the past two years, more HIV-1 infected African adults and children are gaining access to treatment. However, due to complex drug reg...
Detailed Description
Study design: This is a randomized trial comparing adherence to antiretroviral drugs and clinical outcomes between 50 HIV-1 infected Kenyan children randomized to a simple medication diary plus standa...
Eligibility Criteria
Inclusion
- parents/caregivers planning to reside in Nairobi for at least one year after initiation of antiretroviral therapy
- HIV-1 infected children between ages 18 months to 12 years with symptomatic disease (WHO stage II or III) and/or CD4 \<20% \[where CD4 counts available\]
Exclusion
- previous use of antiretroviral drugs by the child apart from drugs taken as part of prevention of mother to child transmission of HIV
- children with end-stage AIDS including widespread disseminated malignancy, and generalized severe encephalopathy
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00194545
Start Date
July 1 2004
End Date
December 1 2006
Last Update
July 9 2012
Active Locations (1)
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1
University of Nairobi
Nairobi, Kenya