- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001062
A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
A Phase I Study of a Fixed-Schedule Regimen of Alternating Oral and Intravenous Ganciclovir for Treatment of Cytomegalovirus Retinitis
To determine whether alternating oral ganciclovir with intravenous ( IV ) ganciclovir can prevent relapse of Cytomegalovirus ( CMV ) retinitis and improve quality of life in AIDS patients.
A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer, without the need for a permanent indwelling IV catheter. Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir, patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease, as opposed to the current therapeutic strategy in which changes in therapy are event-driven. Also, the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer, without the need for a permanent indwelling IV catheter. Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir, patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease, as opposed to the current therapeutic strategy in which changes in therapy are event-driven. Also, the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter.
Patients receive IV induction with ganciclovir for 2 weeks followed by an alternating course of 3 weeks of oral ganciclovir and 1 week of IV drug for four cycles (16 weeks). If CMV retinitis fails to arrest after initial induction, IV ganciclovir is administered for an additional 2 weeks.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA CARE Center CRS
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Illinois
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Chicago, Illinois, United States
- Rush Univ. Med. Ctr. ACTG CRS
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Adult AIDS CRS
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New York
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New York, New York, United States, 10021
- Cornell University A2201
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Unc Aids Crs
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Washington
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Seattle, Washington, United States, 98122
- University of Washington AIDS CRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
- Erythropoietin, G-CSF, or GM-CSF.
- Antiretrovirals.
Patients must have:
- HIV infection.
- Evaluable CMV retinitis with photographable lesions.
- Life expectancy of at least 6 months.
- No active AIDS-defining opportunistic infections or malignancies that require nephrotoxic or myelosuppressive therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Evidence of retinal vascular or related infectious disease or other retinal lesions that would interfere with the ability to detect responses to therapy or progression.
- Corneal, lens, or vitreous opacification precluding funduscopic exam.
- Clinically significant pulmonary or neurologic impairment other than seizure disorder or CNS mass lesion.
- Inability to obtain temporary IV access.
- Requirement for permanent catheters for IV ganciclovir administration.
- Uncontrolled diarrhea or nausea preventing ingestion of medicine.
- Known hypersensitivity to IV or oral ganciclovir.
Concurrent Medication:
Excluded:
- Immunomodulators.
- Biologic response modifiers.
- Interferon.
- Related investigational agents.
- CMV prophylaxis.
- Systemic acyclovir.
- Any nephrotoxic agent.
- Any concomitant therapy that would prohibit use of ganciclovir.
Prior Medication:
Excluded:
- Prior treatment for CMV retinitis.
- More than 4 months of prior ganciclovir or foscarnet, or within 4 weeks prior to study entry.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Holland GN
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Eye Diseases
- Retinal Diseases
- DNA Virus Infections
- Herpesviridae Infections
- Eye Infections
- Eye Infections, Viral
- Cytomegalovirus Infections
- Retinitis
- Cytomegalovirus Retinitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Ganciclovir
- Ganciclovir triphosphate
Other Study ID Numbers
- ACTG 278
- 11254 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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