The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children
Status:
Completed
Trial end date:
1996-09-01
Target enrollment:
Participant gender:
Summary
PRIMARY: To determine the maximum tolerated dose of interferon-alfa (IFN-A) alone and in
combination with zidovudine (AZT); to assess the safety and tolerance of IFN-A alone and in
combination with AZT.
SECONDARY: To evaluate the effect of combination IFN-A and AZT on immunologic and virologic
parameters; to determine whether the pharmacokinetic parameters of AZT are modified by the
subcutaneous administration of IFN-A.
AZT is effective in suppressing the progression of HIV infection in patients without symptoms
or with AIDS or AIDS-related complex (ARC). However, use of AZT is limited by its frequent
toxicity, which sometimes relates to the amount of drug given. Thus, a combination treatment
of two drugs that work together may provide more effective and safer treatment. IFN-A is a
drug that has antiviral effects and may work well with AZT.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)