Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full description
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.
Patients are treated with subcutaneous rIFN-gamma 3 times a week for 24 weeks and are then followed for an additional 12 weeks.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Patients must have:
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
History of uncomplicated febrile seizures does not exclude.)
Prior Medication:
Excluded within 8 weeks prior to study entry:
Prior Treatment:
Excluded:
Required:
Ongoing alcohol or drug use.
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal