Cytomegalovirus InfectionsNCT00002024
Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
A study testing Ganciclovir in people with Cytomegalovirus Infections and HIV Infections, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
To provide ganciclovir on a compassionate use basis to immunocompromised patients with serious cytomegalovirus (CMV) infections and to study safety and efficacy in this patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections, 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Topical acyclovir.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria.
- Transplant where a trial reduction of immunosuppressive drug treatment is not feasible.
- Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency.
- Neutropenia unless it is pre-existing.
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- Thrombocytopenia unless it is pre-existing.
- Concurrent Medication:
- Excluded:
- Other myelosuppressive drugs such as cancer chemotherapy agents, interferon, foscarnet, or nucleoside analogs.
- Patients with the following are excluded:
- Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria.
- Transplant where a trial reduction of immunosuppressive drug treatment is not feasible.
- Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency.
- Neutropenia unless it is pre-existing.
- Thrombocytopenia unless it is pre-existing.
- Patients must be immunocompromised with a serious cytomegalovirus (CMV) infection. This would include pneumonia, gastrointestinal disease, hepatitis, or other organ-specific disease or severe wasting syndrome. Patients with pre-existing neutropenia or thrombocytopenia, and immediate life-threatening disease can be included if the investigator believes that delay in starting ganciclovir therapy is not advisable. In such patients, the investigator must advise the patient of the risk of further marrow suppression and the increased risk of infection or bleeding; and the patient must sign an amended informed consent form.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roche Global Development - Palo Alto
Palo Alto, California, 94303
About this study
To provide ganciclovir on a compassionate use basis to immunocompromised patients with serious cytomegalovirus (CMV) infections and to study safety and efficacy in this patient population.
- Conditions
- Cytomegalovirus Infections, HIV Infections
- Being tested
- Ganciclovir
- Keywords
- AIDS-Related Opportunistic Infections, Immune Tolerance, Ganciclovir, Drugs, Investigational, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Cytomegalovirus Infections, HIV Infections, AIDS-Related Opportunistic Infections, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, 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 Cytomegalovirus InfectionsStudies 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
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002024
- Sponsor's protocol ID
- 029B
- Other IDs
- ICM 1257A
- Status last verified
- Sep 1989
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Spector SA, McKinley GF, Lalezari JP, Samo T, Andruczk R, Follansbee S, Sparti PD, Havlir DV, Simpson G, Buhles W, Wong R, Stempien M. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. Roche Cooperative Oral Ganciclovir Study Group. N Engl J Med. 1996 Jun 6;334(23):1491-7. doi: 10.1056/NEJM199606063342302.
PubMed 8618603
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
- Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
- ClinicalTrials.gov ID
- NCT00002024
- Acronym / sponsor ID
- 029B
- Conditions
- Cytomegalovirus Infections, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Immune Tolerance, Ganciclovir, Drugs, Investigational, Cytomegalovirus Infections, 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 provide ganciclovir on a compassionate use basis to immunocompromised patients with serious cytomegalovirus (CMV) infections and to study safety and efficacy in this patient population.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Topical acyclovir.
Key exclusion criteria (17 listed)
- Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria.
- Transplant where a trial reduction of immunosuppressive drug treatment is not feasible.
- Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency.
- Neutropenia unless it is pre-existing.
- Thrombocytopenia unless it is pre-existing.
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 8618603Spector SA, McKinley GF, Lalezari JP, Samo T, Andruczk R, Follansbee S, Sparti PD, Havlir DV, Simpson G, Buhles W, Wong R, Stempien M. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. Roche Cooperative Oral Ganciclovir Study Group. N Engl J Med. 1996 Jun 6;334(23):1491-7. doi: 10.1056/NEJM199606063342302.
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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 Cytomegalovirus Infections 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 3 inclusion and 17 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 NCT00002024, 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.