Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children
Interferon gamma-1b
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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 MapsTexas Children's Hosp. CRS
Houston, United States