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A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients With AIDS

This study has been completed.

Sponsored by: Hoffmann-La Roche
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002273
  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

MedlinePlus related topics:   AIDS    Cytomegalovirus Infections   

Drug Information available for:   Ganciclovir    Ganciclovir sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind
Official Title:   Double-Blind, Placebo-Controlled Study of Intravenous Ganciclovir (DHPG) for Cytomegalovirus Colitis in Patients With Acquired Immune Deficiency Syndrome
  Eligibility
Ages Eligible for Study:   21 Years and older
Genders 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

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:

Study ID Numbers:   029C, ICM 1288
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002273
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections  
Ganciclovir  
Cytomegalovirus Infections  
Colitis  
Acquired Immunodeficiency Syndrome  

Study placed in the following topic categories:
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Gastrointestinal Diseases
Colonic Diseases
Acquired Immunodeficiency Syndrome
Ganciclovir
Intestinal Diseases
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Digestive System Diseases
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Gastroenteritis
Cytomegalic inclusion disease
Colitis
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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