Search / Trial NCT00000637

A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic 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

Didanosine Drug Evaluation Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine

ClinConnect Summary

AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children.

Patients are placed by random s...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Acetaminophen, ibuprofen, or aspirin, but not on a continual basis for \> 72 hours.
  • Systemic ketoconazole and fluconazole for acute therapy.
  • Recommended:
  • Prophylaxis for PCP. (Primary prophylaxis with TMP / SMX is encouraged.) IV pentamidine may be used in selected cases if not administered on a weekly basis.
  • Patients must have the following:
  • HIV infection.
  • Children randomized prior to their eighteenth birthday are eligible. Co-enrollment in either ACTG 179 or 189 is permitted.
  • Prior Medication:
  • Allowed:
  • Up to six weeks of antiretroviral or immunomodulator treatment excluding steroids and intravenous immunoglobulin.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Active malignancy.
  • Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms.
  • History of uncontrolled seizure disorder.
  • Grade 3 or higher peripheral neuropathy.
  • Cardiomyopathy.
  • Concurrent Medication:
  • Excluded:
  • Chemotherapy for malignancy.
  • Oral acidifying agents.
  • Acetaminophen, ibuprofen, or aspirin on a continual basis for \> 72 hours.
  • Ketoconazole or fluconazole for prophylaxis.
  • Drugs with potential to cause peripheral neuropathy or pancreatitis should not be given daily for \> 4 weeks.
  • Patients with the following are excluded:
  • Active malignancy.
  • Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms.
  • History of uncontrolled seizure disorder.
  • Grade 3 or higher peripheral neuropathy.
  • Prior Medication:
  • Excluded:
  • Steroids.
  • Intravenous immunoglobulin.
  • Antiretroviral drugs or specific immunomodulator treatment (excluding steroids and intravenous immunoglobulin) for \> 6 weeks and within 7 days prior to study entry.
  • Prior Treatment:
  • Excluded:
  • Red blood cell transfusion within four weeks prior to study entry.
  • Ongoing drug or alcohol use.

Trial Officials

Baker C

Study Chair

Englund J

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

Los Angeles, California, United States

Springfield, Massachusetts, United States

New York, New York, United States

Bronx, New York, United States

Birmingham, Alabama, United States

Downey, California, United States

La Jolla, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

Oakland, California, United States

Pasadena, California, United States

San Diego, California, United States

San Francisco, California, United States

Stanford, California, United States

Denver, Colorado, United States

Farmington, Connecticut, United States

New Haven, Connecticut, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Worcester, Massachusetts, United States

Detroit, Michigan, United States

Saint Louis, Missouri, United States

New Brunswick, New Jersey, United States

New Brunswick, New Jersey, United States

Newark, New Jersey, United States

Newark, New Jersey, United States

Albany, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Brooklyn, New York, United States

Brooklyn, New York, United States

Brooklyn, New York, United States

Buffalo, New York, United States

Great Neck, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Valhalla, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Providence, Rhode Island, United States

Charleston, South Carolina, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

Houston, Texas, United States

Seattle, Washington, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

Similar Trials