Status:
COMPLETED
A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Colitis
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE1
Brief Summary
To determine the oral bioavailability of three dose levels of oral ganciclovir given with and without glutamic acid hydrochloride in patients with cytomegalovirus (CMV) GI disease, and to compare the ...
Detailed 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 possi...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
August 1 1998
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00000768
End Date
August 1 1998
Last Update
November 4 2021
Active Locations (5)
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1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
2
Ucsf Aids Crs
San Francisco, California, United States
3
Washington U CRS
St Louis, Missouri, United States
4
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016