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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

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

The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children | DecenTrialz