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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002273
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1989
  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:


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

  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
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:
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
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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Colitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014