Completed

A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes

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What is being tested

Ganciclovir

Drug
Who is being recruted

Cytomegalovirus Retinitis

+ HIV Infections
Over 13 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleA Phase I Study of a Fixed-Schedule Regimen of Alternating Oral and Intravenous Ganciclovir for Treatment of Cytomegalovirus Retinitis 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
25 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cytomegalovirus Retinitis
HIV Infections
Criteria

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 6 locations
Suspended
UCLA CARE Center CRSLos Angeles, United StatesSee the location
Suspended
Rush Univ. Med. Ctr. ACTG CRSChicago, United States
Suspended
Johns Hopkins Adult AIDS CRSBaltimore, United States
Suspended
Cornell University A2201New York, United States

Completed6 Study Centers