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Clinical Trial Summary

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT00001062
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Completion date January 1998

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