Status:
COMPLETED
The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Glaxo Wellcome
Hoffmann-La Roche
Conditions:
HIV Infections
Eligibility:
All Genders
3-17 years
Phase:
PHASE1
Brief Summary
PRIMARY: To determine the maximum tolerated dose of interferon-alfa (IFN-A) alone and in combination with zidovudine (AZT); to assess the safety and tolerance of IFN-A alone and in combination with AZ...
Detailed Description
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...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 1996
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00000967
End Date
September 1 1996
Last Update
October 29 2021
Active Locations (9)
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1
Cook County Hosp.
Chicago, Illinois, United States, 60612
2
Chicago Children's CRS
Chicago, Illinois, United States, 60614
3
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
4
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States, 02118