ColitisNCT00002273
A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients With AIDS
A study testing Ganciclovir in people with Colitis and HIV Infections, run by Hoffmann-La Roche at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Colitis, HIV Infections
- What is being tested?
- Ganciclovir
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roche Global Development - Palo Alto
Palo Alto, California, 94303
About this study
Official title: Double-Blind, Placebo-Controlled Study of Intravenous Ganciclovir (DHPG) for Cytomegalovirus Colitis in Patients With Acquired Immune Deficiency Syndrome
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.
- Conditions
- Colitis, HIV Infections
- Being tested
- Ganciclovir
- Keywords
- AIDS-Related Opportunistic Infections, Ganciclovir, Cytomegalovirus Infections, Colitis, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Colitis, HIV Infections, AIDS-Related Opportunistic Infections, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanciclovirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColitisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002273
- Sponsor's protocol ID
- 029C
- Other IDs
- ICM 1288
- Status last verified
- Sep 1989
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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. doi: 10.1093/infdis/167.2.278.
PubMed 8380610