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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Interferon gamma-1b
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Interferon-gamma, Recombinant, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Children's Hosp. of Philadelphia IMPAACT CRS
  • Texas Children's Hosp. CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00000761
Brief Title
Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children
Official Title
Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 1997 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Genentech, Inc.

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Interferon-gamma, Recombinant, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interferon gamma-1b

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WT Shearer
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
SL Abramson
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
MW Kline
Official's Role
Study Chair
Facility Information:
Facility Name
The Children's Hosp. of Philadelphia IMPAACT CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191044318
Country
United States
Facility Name
Texas Children's Hosp. CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
PubMed Identifier
10225828
Citation
Shearer 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.
Results Reference
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Learn more about this trial

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

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