Search / Trial NCT00000768

A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients

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

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Intestinal Absorption Ganciclovir Drug Therapy, Combination Cytomegalovirus Infections Colitis Administration, Oral Acquired Immunodeficiency Syndrome Biological Availability Glutamic Acid

Description

Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment. Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration, but an optimum dose has not been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug. All patients receive an induction regimen of IV ganciclovir administered twice daily for 21 to 42 (Per Amen...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Recommended:
  • PCP prophylaxis.
  • Allowed:
  • Antiretroviral therapy during induction and pharmacokinetic part of study, provided patient remains on the same antiretroviral therapy for the duration of the study.
  • Chemotherapy for Kaposi's sarcoma, provided patient is hematologically stable for at least 30 days prior to study entry.
  • Recombinant human erythropoietin.
  • GM-CSF and G-CSF.
  • Other medications necessary for patient's welfare, at the physician's discretion.
  • Patients must have:
  • HIV infection.
  • Biopsy-proven cytomegalovirus (CMV) colitis.
  • Life expectancy of at least 3 months.
  • No active AIDS-defining opportunistic infection requiring therapy that is known to cause nephrotoxicity or myelosuppression.
  • NOTE:
  • Kaposi's sarcoma is permitted if patients are hematologically stable for at least 30 days prior to study entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Other etiologies for diarrhea identified at study entry.
  • PER AMENDMENT 3/14/95:
  • For subjects who have diarrhea - no other etiologies for diarrhea identified within 6 weeks of enrollment.
  • Known hypersensitivity to study drugs.
  • CMV retinitis.
  • Concurrent Medication:
  • Excluded:
  • Acyclovir or probenecid (PER AMENDMENT 3/14/95).
  • Immunomodulators.
  • Biologic response modifiers (other than GM-CSF or G-CSF).
  • Investigational agents, with the exception of treatment IND drugs.
  • Antacids.
  • H2 blockers.
  • Proton pump inhibitors.
  • Foscarnet during induction and pharmacokinetic part of study.
  • Intravenous CMV retinitis maintenance therapy (including ganciclovir) during pharmacokinetic part of study.
  • Nephrotoxic agents.
  • Prior Medication:
  • Excluded within 14 days prior to study entry:
  • Immunomodulators.
  • Biologic response modifiers (other than GM-CSF or G-CSF).
  • Investigational agents, with the exception of treatment IND drugs.

Attachments

readout_NCT00000768_2023-12-10.pdf

4.5 MB

NCT00000768_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

Birmingham, Alabama, United States

San Francisco, California, United States

Saint Louis, Missouri, United States

New York, New York, United States

Cincinnati, Ohio, 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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4 stars
6
3 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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