A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
Status:
Completed
Trial end date:
1995-04-01
Target enrollment:
Participant gender:
Summary
PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and
zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated
children.
SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and
laboratory markers of disease progression, as determined by virologic and immunologic
determinations. To evaluate the influence of combination therapy on disease progression as
determined by evaluation of clinical criteria.
In children currently being treated with AZT, it is unknown whether the addition of another
antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will
examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT
alone.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)