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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Interferon Gamma, Recombinant Acquired Immunodeficiency Syndrome Aids Related Complex

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.

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.

Attachments

readout_NCT00000761_2024-05-23.pdf

4.5 MB

NCT00000761_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Houston, Texas, United States

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
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2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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