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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

Trial Information

Current as of May 11, 2025

Completed

Keywords

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

ClinConnect Summary

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.

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

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

Patients applied

0 patients applied

Trial Officials

Jacobson M

Study Chair

Dieterich D

Study Chair

Kotler D

Study Chair

Laine L

Study Chair

Kumar P

Study Chair

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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