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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 AMENDME...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Antiretroviral therapy.
• • Anti-PCP prophylaxis.
• • Maintenance or prophylaxis therapy for other opportunistic infections besides CMV.
• Patients must have:
• • Working diagnosis of HIV infection.
• • CD4 count \<= 100 cells/mm3.
• • Positive CMV serology (IgG) or CMV culture, in the absence of active disease, documented at any time prior to study entry.
• • Reasonably good health.
• • Life expectancy of at least 6 months.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Acute life-threatening illness.
• • Active lymphoma.
• • Hypersensitivity to acyclovir.
• • Lack of willingness or ability, in the opinion of the clinician, to comply with protocol requirements.
• Concurrent Medication:
• Excluded:
• • Vidarabine.
• • Amantadine hydrochloride (Symmetrel).
• • CMV hyperimmune globulin/intravenous immune globulin.
• • Cytarabine.
• • Fiacitabine (FIAC) or fialuridine (FIAU).
• • Foscarnet.
• • Intravenous ganciclovir.
• • HPMPC.
• • Idoxuridine.
• • Intravenous acyclovir.
• • Oral acyclovir at \> 1 g/day.
• • Other drugs with potential anti-CMV activity.
• Prior Medication:
• Excluded within 60 days prior to study entry:
• • Foscarnet.
• Excluded within 2 weeks prior to study entry:
• • Vidarabine.
• • Amantadine hydrochloride (Symmetrel).
• • CMV hyperimmune globulin/intravenous immune globulin.
• • Cytarabine.
• • Fiacitabine (FIAC) or fialuridine (FIAU).
• • Ganciclovir.
• • HPMPC.
• • Idoxuridine.
• • Intravenous acyclovir.
• • Oral acyclovir at \> 1 g/day.
• • Other drugs with potential anti-CMV activity.

Trial Officials