Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Genentech, Inc.

Conditions:

HIV Infections

Eligibility:

All Genders

1-17 years

Phase:

PHASE1

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...

Detailed 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 be...

Eligibility Criteria

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

October 1 1997

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00000761

End Date

October 1 1997

Last Update

November 3 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

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