NCT00001034

The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV

A Randomized, Comparative, Placebo-Controlled Trial of the Safety and Efficacy of Oral Ganciclovir for Prophylaxis of Cytomegalovirus (CMV) Retinal and Gastrointestinal Mucosal Disease in HIV-Infected Individuals With Severe Immunosuppression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 850 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of oral ganciclovir for prophylaxis against cytomegalovirus (CMV) retinal and gastrointestinal mucosal disease in HIV-infected patients with severe immunosuppression. The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.

Detailed description

The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis. Patients are randomized in a 2:1 ratio to receive either oral ganciclovir or placebo for a minimum of 12 months. PER AMENDMENT 9/19/94: Patients who have not reached a study endpoint may choose to continue blinded prophylaxis or discontinue blinded prophylaxis and begin open-label ganciclovir. PER AMENDMENT 5/2/95: After the common closing date (6/3/95) patients who have not met a CMV end point or experienced a serious toxicity that required permanent discontinuation of active oral ganciclovir will be eligible to receive open-label oral ganciclovir through an open-label extension phase of study 023 until 8/31/95.

Conditions

• Cytomegalovirus Retinitis
• HIV Infections
• Gastrointestinal Diseases

Interventions

Type	Name	Description
DRUG	Ganciclovir

Timeline

• Completion: 1995-08-01
• First posted: 2001-08-31
• Last updated: 2021-11-04

Locations

17 sites across 1 country: United States