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
- Are there results?
- None posted in the registry
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:
Show all 25Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled Study of Intravenous Ganciclovir (DHPG) for Cytomegalovirus Colitis in Patients With Acquired Immune Deficiency Syndrome
- ClinicalTrials.gov ID
- NCT00002273
- Acronym / sponsor ID
- 029C
- Conditions
- Colitis, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Ganciclovir, Cytomegalovirus Infections, Colitis, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.)
- Topical acyclovir.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ganciclovir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 8380610Dieterich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ganciclovir in people with Colitis and HIV Infections, run by Hoffmann-La Roche at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.