Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
Status:
Completed
Trial end date:
1998-10-01
Target enrollment:
Participant gender:
Summary
To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone
and in combination with didanosine (ddI), and whether concurrent administration alters the
disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long
term changes from baseline in plasma HIV RNA concentrations. To determine the relationship,
if any, between drug exposure and viral burden.
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the
three children with baseline counts greater than 50 cells/micro liter experienced a 20%
increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the
same regimen for children with less advanced HIV disease should be undertaken.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)