A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients With AIDS - Full Text View

Purpose

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.

Condition	Intervention
Colitis HIV Infections	Drug: Ganciclovir


Study Type:	Interventional
Study Design:	Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Double-Blind, Placebo-Controlled Study of Intravenous Ganciclovir (DHPG) for Cytomegalovirus Colitis in Patients With Acquired Immune Deficiency Syndrome

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ganciclovir Ganciclovir sodium

Genetic and Rare Diseases Information Center resources: Cytomegalic Inclusion Disease

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility


Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002273

Locations


United States, California
Roche Global Development - Palo Alto
Palo Alto, California, United States, 94303

Sponsors and Collaborators

Hoffmann-La Roche

More Information

Publications:

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.


ClinicalTrials.gov Identifier:	NCT00002273 History of Changes
Other Study ID Numbers:	029C ICM 1288
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005

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

ClinicalTrials.gov processed this record on June 23, 2017