Completed

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

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What is being tested

Interferon gamma-1b

Drug
Who is being recruted

HIV Infections

From 12 Months to 17 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 3, 2021
Sourced from a government-validated database.Claim as a partner

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.

Official TitlePhase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 3, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
20 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 12 Months to 17 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
The Children's Hosp. of Philadelphia IMPAACT CRSPhiladelphia, United StatesSee the location
Suspended
Texas Children's Hosp. CRSHouston, United States

Completed2 Study Centers