Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children
2 other identifiers
interventional
20
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
October 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 3, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, 191044318, United States
Texas Children's Hosp. CRS
Houston, Texas, 77030, United States
Related Publications (2)
Kline MW, Fletcher CV, Douglas SD, Fenton T, Shearer WT. Recombinant human interferon-gamma (rIFN-gamma) treatment of HIV-infected children. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:143 (abstract no 424)
BACKGROUNDShearer WT, Kline MW, Abramson SL, Fenton T, Starr SE, Douglas SD. Recombinant human gamma interferon in human immunodeficiency virus-infected children: safety, CD4(+)-lymphocyte count, viral load, and neutrophil function (AIDS Clinical Trials Group Protocol 211). Clin Diagn Lab Immunol. 1999 May;6(3):311-5. doi: 10.1128/CDLI.6.3.311-315.1999.
PMID: 10225828BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
WT Shearer
- STUDY CHAIR
SL Abramson
- STUDY CHAIR
MW Kline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
October 1, 1997
Last Updated
November 3, 2021
Record last verified: 2021-10