Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000761

Collaborator

Genentech, Inc. (Industry)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Interferon gamma-1b	Phase 1

Detailed Description

Patients are treated with subcutaneous rIFN-gamma 3 times a week for 24 weeks and are then followed for an additional 12 weeks.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children

Actual Study Completion Date :

Oct 1, 1997

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Concurrent Medication:

Required:

AZT or ddI therapy.
PCP prophylaxis.

Allowed:

Antipyretics.
Antiemetics.
Antihistamines.
Decongestants.
Skin creams and lotions.
Immunizations according to current recommendations.

Patients must have:

Class P-2 symptomatic HIV infection.
Ongoing AZT or ddI therapy of 6 months or longer duration.

Exclusion Criteria

Concurrent Medication:

Excluded:

Antiretroviral therapy other than AZT or ddI.
Chemotherapy for active malignancy.
Amphotericin B for systemic fungal infections.

Patients with the following prior conditions are excluded:

History of congestive heart failure or arrhythmias.
History of congenital heart disease.
History of seizure disorder requiring anticonvulsant medication. (NOTE:

History of uncomplicated febrile seizures does not exclude.)

Prior Medication:

Excluded within 8 weeks prior to study entry:

Immunomodulators other than IVIG.

Prior Treatment:

Excluded:

Red blood cell transfusion within 4 weeks prior to study entry.

Required:

Ongoing AZT or ddI therapy of 6 weeks or longer duration.
Ongoing PCP prophylaxis for more than 6 weeks duration.

Ongoing alcohol or drug use.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Children's Hosp. of Philadelphia IMPAACT CRS	Philadelphia	Pennsylvania	United States	191044318
2	Texas Children's Hosp. CRS	Houston	Texas	United States	77030