Search / Trial NCT00000761

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 27, 2024

Completed

Keywords

Interferon Gamma, Recombinant Acquired Immunodeficiency Syndrome Aids Related Complex

ClinConnect Summary

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.

Gender

ALL

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.

Trial Officials

WT Shearer

Study Chair

SL Abramson

Study Chair

MW Kline

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Houston, Texas, United States

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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