Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children
Status:
Completed
Trial end date:
1997-10-01
Target enrollment:
Participant gender:
Summary
PRIMARY: To determine the safety and toxicity of recombinant interferon gamma-1b ( rIFN-gamma
) in HIV-infected children receiving ongoing zidovudine ( AZT ) or didanosine ( ddI )
therapy. To document HIV-associated defects in neutrophil and/or monocyte function that are
improved with rIFN-gamma.
SECONDARY: To determine whether a change in CD4 cell count occurs and to assess virologic
status and effects on AZT and ddI pharmacokinetics.
It is likely that infants and children severely immunocompromised by HIV infection would
respond to immunomodulators that augment different portions of the host defense system.
Interferon-gamma has been shown to benefit children with severely compromised nonspecific
immunity and may thus be of benefit to those with HIV infection.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)