A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients With AIDS
Double-Blind, Placebo-Controlled Study of Intravenous Ganciclovir (DHPG) for Cytomegalovirus Colitis in Patients With Acquired Immune Deficiency Syndrome
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
To attempt to demonstrate the efficacy of ganciclovir (DHPG) treatment of cytomegalovirus (CMV) colitis in AIDS patients by evaluating both clinical and virologic parameters. To determine acceptability and the safety profile of a 2-week course of intravenous (IV) DHPG therapy.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
September 1, 1989
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- An underlying diagnosis of AIDS by CDC surveillance definition (group IV, category c-1 or subgroup D only).
- Colitis manifested clinically by diarrhea.
- Colon biopsy demonstrating a typical histologic picture of cytomegalovirus (CMV) disease.
- Prior Medication:
- Allowed:
- Topical acyclovir.
You may not qualify if:
- Co-existing Condition:
- Patients with the following are excluded:
- History of chronic or acute liver disease.
- History of significant mental illness.
- Life expectancy \< 1 month.
- Presence of any cause of colitis other than cytomegalovirus (CMV). (The following tests must be negative:
- Stool culture for enteric bacterial pathogens, stool exam for ova and parasites, stool exam for cryptosporidia, stool exam for AFB.) Colitis that is so severe that it would be against the patient's best interest to be treated with placebo for 2 weeks prior to being eligible to receive ganciclovir (DHPG) on a "compassionate" use basis. Patients with a colitis of this severity should be treated with DHPG on "compassionate" use basis.
- Presence of clinically significant extra-colonic active CMV disease of retina or visceral organs (which could progress during the no-treatment period).
- Presence of significant renal disease resulting in any decrement of creatinine clearance from normal.
- Concurrent Medication:
- Excluded:
- Any other investigational drug, whether or not as part of a formal clinical study.
- Patients with the following are excluded:
- History of chronic or acute liver disease.
- History of significant mental illness.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roche Global Development - Palo Alto
Palo Alto, California, 94303, United States
Related Publications (1)
Dieterich DT, Kotler DP, Busch DF, Crumpacker C, Du Mond C, Dearmand B, Buhles W. Ganciclovir treatment of cytomegalovirus colitis in AIDS: a randomized, double-blind, placebo-controlled multicenter study. J Infect Dis. 1993 Feb;167(2):278-82. doi: 10.1093/infdis/167.2.278.
PMID: 8380610BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1989-09