A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients With AIDS
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ClinicalTrials.gov Identifier: NCT00002273 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colitis HIV Infections | Drug: Ganciclovir | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Double-Blind, Placebo-Controlled Study of Intravenous Ganciclovir (DHPG) for Cytomegalovirus Colitis in Patients With Acquired Immune Deficiency Syndrome |


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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
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.
- Cultures for CMV from blood and urine should be obtained within 1 week of study entry but need not be positive prior to entry. (A positive culture is needed for final inclusion in AN.)
Prior Medication:
Allowed:
- Topical acyclovir.
Exclusion Criteria
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.
- 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.
Prior Medication:
Excluded within 2 days of study entry:
- Nucleoside analogs.
- Excluded within 1 week of study entry:
- Antimetabolites or interferon.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002273
United States, California | |
Roche Global Development - Palo Alto | |
Palo Alto, California, United States, 94303 |
Publications:
ClinicalTrials.gov Identifier: | NCT00002273 History of Changes |
Other Study ID Numbers: |
029C ICM 1288 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | September 1989 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Ganciclovir Cytomegalovirus Infections Colitis Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
Infection HIV Infections Colitis Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Slow Virus Diseases Ganciclovir Ganciclovir triphosphate Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |