Cytomegalovirus RetinitisNCT00002015
An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
A study testing Ganciclovir in people with Cytomegalovirus Retinitis and HIV Infections, run by Roche Global Development at 8 sites in United States.
Trial summary
To evaluate the pharmacokinetics of intravenous ganciclovir in children (ages 3 months - 12 years). To determine the safety and tolerance of a 2 to 3 week induction course of ganciclovir IV in immunocompromised children receiving treatment for life- or sight-threatening cytomegalovirus infections. Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- Cytomegalovirus Retinitis, HIV Infections
- What is being tested?
- Ganciclovir
- How many people
- 20 participants
- Where
- 8 sitesUnited 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 3 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Allowed:
- Topical acyclovir.
- Consult with the Syntex study monitor for the following:
- Cytokines.
- Soluble CD4.
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- Trichosanthin (Compound Q).
- Imipenem-cilastatin.
- Other investigational drugs.
- Patients must have the following:
- Congenital or acquired immune deficiency.
- Eligibility to receive ganciclovir for the treatment of life- or sight-threatening Cytomegalovirus (CMV) disease.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Mild to moderate Cytomegalovirus infection that does not satisfy the clinical severity criteria.
- Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency.
- Concurrent Medication:
- Excluded:
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- Other myelosuppressive drugs.
- Antimetabolites.
- Alkylating agents.
- Nucleoside analogs (topical acyclovir is allowed).
- Interferons.
- Foscarnet.
- Consult with the Syntex study monitor for the following:
- Cytokines.
- Soluble CD4.
- Trichosanthin (Compound Q).
- Imipenem-cilastatin.
- Other investigational drugs.
- Patients with the following are excluded:
- Mild to moderate Cytomegalovirus (CMV) infection that does not meet the clinical severity criteria.
- Absolute neutrophil count (ANC) < 500 cells/mm3 or a platelet count < 25000 platelets/mm3. Note:
- Exceptions may be made for patients with pre-existing neutropenia or thrombocytopenia and immediately life-threatening disease, if the investigator believes that a delay in starting ganciclovir therapy is not advisable. In such patients, the investigator should advise the parents or guardians of the risk of further bone marrow suppression and the increased risk of infection or bleeding.
- Receiving excluded medications that it is not possible to discontinue.
- Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency.
- Demonstrated hypersensitivity to acyclovir or ganciclovir.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Univ of Chicago / Wylers
Chicago, Illinois, 60637
Baylor College of Medicine / Texas Children's Hosp
Houston, Texas, 77030
Children's Hosp of Los Angeles
Los Angeles, California, 90027
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Ctr for the Health Sciences / UCLA Med Ctr
Los Angeles, California, 90095
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681983280
Univ of Rochester Med Ctr
Rochester, New York, 14642
About this study
To evaluate the pharmacokinetics of intravenous ganciclovir in children (ages 3 months - 12 years). To determine the safety and tolerance of a 2 to 3 week induction course of ganciclovir IV in immunocompromised children receiving treatment for life- or sight-threatening cytomegalovirus infections.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Ganciclovir
- Keywords
- Retinitis, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Immunocompromised Host
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, Retinitis, 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.
- Other trials for Cytomegalovirus RetinitisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Roche Global Development
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002015
- Sponsor's protocol ID
- 029G
- Other IDs
- ICM 1788
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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
- An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
- ClinicalTrials.gov ID
- NCT00002015
- Acronym / sponsor ID
- 029G
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- Retinitis, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Immunocompromised Host
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Roche Global DevelopmentUniversity, hospital or other
- 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 evaluate the pharmacokinetics of intravenous ganciclovir in children (ages 3 months - 12 years). To determine the safety and tolerance of a 2 to 3 week induction course of ganciclovir IV in immunocompromised children receiving treatment for life- or sight-threatening cytomegalovirus infections.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Topical acyclovir.
- Consult with the Syntex study monitor for the following:
- Cytokines.
- Soluble CD4.
- Trichosanthin (Compound Q).
Key exclusion criteria (25 listed)
- Mild to moderate Cytomegalovirus infection that does not satisfy the clinical severity criteria.
- Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency.
- Other myelosuppressive drugs.
- Antimetabolites.
- Alkylating agents.
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.
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Cytomegalovirus Retinitis, Ganciclovir Eye Drops
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.
8 sites 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 Retinitis and HIV Infections, run by Roche Global Development at 8 sites 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 12 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 8 sites 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?
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.