Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Interferon gamma-1b

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

From 1 to 17 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

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

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.

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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV 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

The Children's Hosp. of Philadelphia IMPAACT CRS

Philadelphia, United StatesOpen The Children's Hosp. of Philadelphia IMPAACT CRS in Google Maps

Texas Children's Hosp. CRS

Houston, United States
Completed2 Study Centers