Search / Trial NCT00000833

A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.

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

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Trial Information

Current as of December 03, 2023

Completed

Keywords

Ribavirin Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents

Description

Ribavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of ddI. Patients are divided into two cohorts. Subjects will be stratified by age 3 months to < 24 months and >= 24 months to 12 years. Fifty % of patients from each age group will be assigned to each cohort. Cohort 1 receives ddI monotherapy for 4 weeks, followed by combination ddl/ribavirin therapy for an additional 20 weeks. Coho...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Recommended:
  • PCP prophylaxis.
  • Allowed:
  • Acetaminophen for no more than 72 hours.
  • Immunoglobulin.
  • Corticosteroids.
  • Erythropoietin.
  • G-CSF and GM-CSF.
  • Ethionamide or isoniazid for TB if no alternative available.
  • Immunizations according to current recommendations.
  • Patients must have:
  • HIV infection.
  • Immunologic abnormality or clinical symptoms as detailed in the Disease Status field.
  • No active AIDS-defining opportunistic infection or malignancy, no progressive encephalopathy attributable to HIV and no chronic persistent diarrhea.
  • Consent of parent or guardian.
  • PER AMENDMENT 7/2/96:
  • At least 2 of the 5 children in the older half of each cohort must have an ICD p24 antigen concentration >= 70 pg/ml at screening.
  • Prior Medication:
  • Allowed:
  • Up to 6 weeks of prior immunomodulator therapy.
  • Maternal immunomodulator or antiretroviral therapy, including during pregnancy.
  • Prior corticosteroids or intravenous immunoglobulin.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Current grade 3 or worse neuropathy/lower motor neuropathy.
  • Clinical or laboratory grade 3 or worse toxicities.
  • Active serious bacterial infection.
  • Concurrent Medication:
  • Excluded:
  • Chemotherapy for active malignancy.
  • Antiretrovirals other than study drugs.
  • Immunomodulators unless specifically allowed.
  • Patients with the following prior condition are excluded:
  • History of grade 3 or worse neuropathy/lower motor neuropathy.
  • Prior Medication:
  • Excluded:
  • Prior ddI or oral ribavirin.
  • Aerosolized ribavirin within 6 weeks prior to study entry.
  • Antiretroviral or immunomodulator therapy (other than corticosteroids or IVIG) within 1 week prior to blood draws for study entry.
  • Ongoing drug or alcohol abuse.

Attachments

readout_NCT00000833_2023-12-03.pdf

4.5 MB

NCT00000833_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

Bronx, New York, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Boston, Massachusetts, United States

Newark, New Jersey, 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

Houston, Texas, United States

San Juan, , Puerto Rico

Newark, New Jersey, United States

Research Triangle Park, North Carolina, United States

New Orleans, Louisiana, United States

Jacksonville, Florida, 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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