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
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.
Contacts
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
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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