Search / Trial NCT00001032

A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Zalcitabine Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine

Description

In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone. Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC. Patients receive therapy until the last patient enrolled completes 32 weeks of therapy. The study may be extended for two additional 32-week periods on an optional basis.

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Recommended:
  • PCP prophylaxis.
  • Allowed:
  • Intravenous and/or intramuscular immunoglobulin.
  • Acyclovir (no more than 30 mg/kg/day PO).
  • Ketoconazole (no more than 10 mg/kg/day).
  • Nystatin.
  • Aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, sedatives, and barbiturates, not to exceed 72 hours.
  • Isoniazid in combination with pyridoxine, provided there is no evidence of peripheral neuropathy.
  • Trimethoprim / sulfamethoxazole.
  • Amphotericin B (no more than 1 mg/kg for 5 days/week).
  • Aerosolized ribavirin for bronchiolitis.
  • Hematopoietic agents.
  • Other drugs with little nephro-, hepato-, or cytotoxicity.
  • Nutritional support for HIV wasting syndrome or malnutrition.
  • Patients must have:
  • HIV infection.
  • Ongoing stable AZT therapy.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Disease progression while on AZT, to the extent that the patient meets the criteria for advanced disease protocols.
  • Known allergy or sensitivity to ddC.
  • Cardiomyopathy.
  • Concurrent Medication:
  • Excluded:
  • Biologic modifiers other than IVIG, steroids, or hematopoietic agents.
  • Investigational medications unless approved by protocol chair.
  • Medications known to cause pancreatitis (unless ddC is interrupted while these medications are given).
  • Patients with the following prior conditions are excluded:
  • History of intolerance or toxicity to AZT.
  • History of symptomatic pancreatitis.
  • History of peripheral neuropathy or abnormal nerve conduction velocity test.
  • Prior Medication:
  • Excluded:
  • Antiretroviral agents other than AZT within 2 weeks of study entry.
  • Required:
  • Ongoing stable AZT therapy for more than 6 weeks duration.

Attachments

readout_NCT00001032_2024-03-02.pdf

4.5 MB

NCT00001032_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Oakland, California, United States

San Diego, California, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

New York, New York, United States

Rochester, New York, United States

Los Angeles, California, United States

San Francisco, California, 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

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Springfield, Massachusetts, United States

Worcester, Massachusetts, United States

New Brunswick, New Jersey, United States

Bronx, New York, United States

Brooklyn, 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

Durham, North Carolina, United States

Philadelphia, Pennsylvania, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Long Beach, California, United States

Los Angeles, California, United States

Torrance, California, United States

Washington, District Of Columbia, United States

Chicago, Illinois, United States

Detroit, Michigan, United States

Paterson, New Jersey, United States

New York, New York, United States

Syracuse, New York, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Seattle, Washington, United States

San Francisco, California, United States

Farmington, Connecticut, United States

New Haven, Connecticut, United States

Albany, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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