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

• Status: Completed
• Trial end date: 1995-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Hoffmann-La Roche
• Treatments: Ganciclovir; Ganciclovir triphosphate

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.