The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of June 30, 2025
Completed
Keywords
ClinConnect Summary
AZT is effective in suppressing the progression of HIV infection in patients without symptoms or with AIDS or AIDS-related complex (ARC). However, use of AZT is limited by its frequent toxicity, which sometimes relates to the amount of drug given. Thus, a combination treatment of two drugs that work together may provide more effective and safer treatment. IFN-A is a drug that has antiviral effects and may work well with AZT.
The study is being conducted in three stages. In Cohort A (IFN-A alone), four patients receive IFN-A; subsequent four-patient cohorts receive doses escalated in increm...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Recommended:
- • Prophylaxis for Pneumocystis carinii pneumonia.
- Allowed:
- • Aerosol ribavirin for short-term treatment of acute respiratory syncytial virus (RSV).
- • Immunization according to the current recommendations of the Advisory Committee for Immunization Practice.
- • IVIG. Systemic ketoconazole, acyclovir, or oral nystatin for acute therapy.
- Patients must have the following:
- • HIV infection. Patients with proven resistance to AZT are also eligible.
- Prior Medication:
- Allowed:
- • Aerosol ribavirin.
- Required:
- Cohort C treatment:
- • Stable prescribed dose of zidovudine (AZT) \>= 90 mg/m2 for at least 6 weeks prior to study entry.
- • Exclusion Criteria
- Co-existing Condition:
- • Patients with the following conditions or symptoms are excluded: AIDS or class P-2B, D, or E symptomatic infection.
- Concurrent Medication:
- Excluded:
- • Hepatotoxic or neurotoxic drugs, immunosuppressants, or antiseizure medication. Ketoconazole, fluconazole, and acyclovir for prophylaxis. Immunomodulators (other than IVIG). Experimental drugs.
- Cohort A patients:
- • AZT for clinical indications.
- Prior Medication:
- Excluded:
- • Other antiretroviral agents (including didanosine (ddI), dideoxycytidine (ddC), or soluble CD4) within 1 month of study entry. Systemic ribavirin administered for retroviral therapy within 2 months of study entry.
- • Immunomodulating agents including interferon, isoprinosine, interleukin-2, or lymphocyte transfusions within 4 weeks of study entry.
- • RBC transfusion within 4 weeks prior to study entry.
- • Alcohol or drug abuse.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Orleans, Louisiana, United States
New York, New York, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Memphis, Tennessee, United States
Patients applied
Trial Officials
Diaz C
Study Chair
Yogev R
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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