Search / Trial NCT00000805

A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease

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

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome

Description

Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS patients is now standard therapy, but daily IV therapy can be complicated by catheter infections and thrombosis. An oral regimen of ganciclovir has been administered safely in adult AIDS patients and may be of significant benefit to children and infants as well. Patients are assigned to 1 of 5 (PER AMENDMENT 10/24/95, was 4) oral (syrup or capsules) dose levels following a single intravenous dose of ganciclovir. Treatment continues for 72 (PER AMENDMENT 10/24/95, was 24 weeks) weeks after the last...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • PER AMENDMENT 10/24/95: Allowed:
  • All antiretroviral agents and other medications except those listed under Exclusion - Concurrent Medications.
  • Didanosine. However, patients receiving both drugs (didanosine and ganciclovir) should be monitored for toxicity.
  • Amphotericin B is allowed but requires additional monitoring.
  • Patients must have:
  • HIV infection.
  • CMV infection.
  • CD4 count < 150 cells/mm3 or < 15 percent AND/OR quiescent CMV disease.
  • NO loss of sight from CMV retinitis.
  • NO acute opportunistic infection.
  • Life expectancy at least to study completion.
  • Consent of parent or guardian.
  • NOTE:
  • Infants < 6 months of age at enrollment must have been >= 36 weeks gestational age at birth.
  • NOTE:
  • Patients may co-enroll in other ACTG protocols that do not involve the administration of disallowed medications.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Loss of sight in one eye for any reason, with evidence of CMV retinitis in the other eye.
  • Acute or chronic diarrhea that would affect absorption.
  • Clinical or laboratory toxicities of grade 3 or worse.
  • Concurrent Medication:
  • Excluded:
  • Foscarnet.
  • Acyclovir.
  • Interferon.
  • Myelotoxic agents for malignancy or other condition.
  • Other agents with anti-CMV activity. (NOTE:
  • Enrollment of patients on IVIG must be discussed with protocol chair.)
  • Imipenem/cilastatin sodium.
  • Prior Medication:
  • Excluded within 30 days prior to study entry:
  • G-CSF or GM-CSF.

Attachments

readout_NCT00000805_2024-06-14.pdf

4.5 MB

NCT00000805_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

Los Angeles, California, United States

Miami, Florida, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

San Juan, , Puerto Rico

Los Angeles, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Paterson, New Jersey, United States

New York, New York, United States

Seattle, Washington, United States

Los Angeles, California, 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

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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