Search / Trial NCT00000967

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 December 06, 2024

Completed

Keywords

Drug Therapy, Combination Aids Related Complex Zidovudine Interferon Type I

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.

Trial Officials

Diaz C

Study Chair

Yogev R

Study Chair

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.

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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