Status:
COMPLETED
Ganciclovir Implant Study for Cytomegalovirus Retinitis
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
HIV Infections
Acquired Immunodeficiency Syndrome
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
To determine the therapeutic efficacy of a sustained-release intraocular drug delivery system for ganciclovir therapy of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency synd...
Detailed Description
CMV retinitis occurs in 20 to 30 percent of patients with AIDS and is the leading cause of visual loss in these patients. At present, ganciclovir and foscarnet are the only drugs that have been approv...
Eligibility Criteria
All patients must have had AIDS as defined by the Centers for Disease Control and Prevention and non-sight-threatening CMV retinitis Patients could not have been previously treated with systemic ganciclovir or foscarnet and must not have had evidence of other organ involvement with CMV. Patients must have had an absolute neutrophil count (ANC) greater than 1,000 cells/mL and a platelet count greater than 25,000/mm3
Key Trial Info
Start Date :
October 1 1992
Trial Type :
INTERVENTIONAL
End Date :
December 1 1993
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00000118
Start Date
October 1 1992
End Date
December 1 1993
Last Update
September 17 2009
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