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NCT00000761 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00000761 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants.
The verdict
NCT00000761, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- DRUG Interferon gamma-1b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Est. Completion | 1997-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000761
The ClinicalTrials.gov registry entry for NCT00000761 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Interferon gamma-1b is the first listed.
NCT00000761 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000761 about?
NCT00000761 is a clinical study titled "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. S...
What is the current status of trial NCT00000761?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. Estimated completion is 1997-10.
What interventions are being tested in trial NCT00000761?
The interventions under investigation include: Interferon gamma-1b (DRUG).
Who is sponsoring clinical trial NCT00000761?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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