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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000761
First received: November 2, 1999
Last updated: April 27, 2012
Last verified: April 2012

November 2, 1999
April 27, 2012
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Complete list of historical versions of study NCT00000761 on ClinicalTrials.gov Archive Site
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Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children
Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Interferon gamma-1b
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 1997
Not Provided

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.

Both
1 Year to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000761
ACTG 211, 11188
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Genentech, Inc.
Study Chair: WT Shearer
Study Chair: SL Abramson
Study Chair: MW Kline
National Institute of Allergy and Infectious Diseases (NIAID)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP