Search / Trial NCT00000843

The Safety and Effectiveness of Adefovir Dipivoxil 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 May 23, 2024

Completed

Keywords

Antiviral Agents Adenine

Description

Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has resulted in increased bioavailability in adult patients in clinical trials. However, the safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and the direction of the variation is not predictable. This study will assess these parameters of bis-POM PMEA in children. Patients are stratified by age, and separate cohorts from each age group receive 1 of 2 single doses of bis-POM PMEA. The lower dose is given to patients ages 3 months through 17 years; if toxicity is ...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Asymptomatic or mildly symptomatic HIV infection, with no worse than grade 1 toxicity for any symptoms.
  • Consent of parent or guardian.
  • Prior Medication:
  • Allowed:
  • IV gammaglobulin and aerosolized pentamidine for PCP prophylaxis.
  • Antiretrovirals if discontinued by 72 hr prior to study entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Acute or chronic infections that require treatment during study.
  • Concurrent Medication:
  • Excluded:
  • Antiretrovirals other than study drug.
  • Other investigational agents.
  • Immunomodulators.
  • HIV-1 vaccines.
  • Glucocorticoids.
  • Drugs with potential for adverse interaction with study drug or that would interfere with quantitation of study drug in serum or plasma.
  • TMP / SMX and dapsone.
  • PER AMENDMENT 8/23/96:
  • Drugs which may affect renal excretion:
  • Probenecid, Acyclovir, Ganciclovir, Foscarnet, Amphotericin B and Pentamidine.
  • Prior Medication:
  • Excluded within 72 hr prior to study entry:
  • Antiretrovirals other than study drug.
  • Other investigational agents.
  • Immunomodulators.
  • HIV-1 vaccines.
  • Glucocorticoids.
  • Drugs with potential for adverse interaction with study drug or that would interfere with quantitation of study drug in serum or plasma.
  • TMP / SMX and dapsone.
  • PER AMENDMENT 8/23/96:
  • Drugs which may affect renal excretion:
  • Probenecid, Acyclovir, Ganciclovir, Foscarnet, Amphotericin B and Pentamidine.

Attachments

readout_NCT00000843_2024-05-23.pdf

4.5 MB

NCT00000843_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

San Francisco, California, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Newark, New Jersey, United States

Philadelphia, Pennsylvania, United States

Memphis, Tennessee, United States

San Juan, , Puerto Rico

Jacksonville, Florida, United States

Nashville, Tennessee, 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
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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?

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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