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

NCT ID: NCT00000761

Last Updated: 2021-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1997-10-31

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.

Conditions

HIV Infections

Keywords

Interferon-gamma, Recombinant; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Interferon gamma-1b

Intervention Type: DRUG

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

WT Shearer

Role: STUDY_CHAIR

SL Abramson

Role: STUDY_CHAIR

MW Kline

Role: STUDY_CHAIR

Locations

The Children's Hosp. of Philadelphia IMPAACT CRS

Philadelphia, Pennsylvania, United States

Texas Children's Hosp. CRS

Houston, Texas, United States

Countries

United States

References

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)

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 10225828 (View on PubMed)

Other Identifiers

11188

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 211

Identifier Type: -

Identifier Source: org_study_id