Search / Trial NCT00000963

A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine

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

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Trial Information

Current as of February 21, 2024

Completed

Keywords

Didanosine Drug Evaluation Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine

Description

The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important. Children who show AZT intolerance and/or progressive disease after 6 months ...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).
  • Immunoglobulin.
  • Maintenance therapy with amphotericin B (l mg/kg) up to 5 days/week.
  • Concurrent Treatment:
  • Allowed:
  • Blood transfusions.
  • Prior Medication:
  • Allowed:
  • Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).
  • Patients enrolled in ACTG 128 and ACTG 138 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this study.
  • Patients currently enrolled in ACTG 051 who have not reached the study end points but who meet the entry criteria for ACTG 144 may be co-enrolled in ACTG 144.
  • Patient or guardian available to give written informed consent.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded.
  • Hypersensitivity to didanosine (ddI).
  • Symptomatic cardiomyopathy.
  • Seizures that are not well controlled by ongoing anticonvulsant therapy.
  • Symptomatic pancreatitis.
  • Grade 1 or higher peripheral neuropathy.
  • Active malignancy requiring chemotherapy.
  • Concurrent Medication:
  • Excluded:
  • Zidovudine (AZT), other antiretroviral agents, biological modifiers, and investigational medications.
  • Avoid:
  • Drugs with potential to cause peripheral neuropathy or pancreatitis.
  • Patients with the following are excluded:
  • Active malignancy requiring concomitant chemotherapy.
  • Prior Medication:
  • Excluded:
  • Antiretroviral agents other than zidovudine (AZT) or dideoxycytidine (ddC) within 4 weeks of study entry.
  • Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.
  • Any other experimental therapy within 1 week of entry.
  • Drugs that have or will cause prolonged neutropenia, significant pancreatitis, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.

Attachments

readout_NCT00000963_2024-02-21.pdf

4.5 MB

NCT00000963_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

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

New York, New York, United States

Rochester, New York, United States

Cleveland, Ohio, 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

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

Houston, Texas, 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

Stony Brook, New York, United States

Syracuse, New York, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Seattle, Washington, United States

Farmington, Connecticut, United States

New Haven, Connecticut, United States

Albany, New York, United States

Dallas, Texas, 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
0
Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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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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