CMV Retinitis Retreatment Trial

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety and efficacy of three therapeutic regimens (foscarnet, ganciclovir, or the combination) for recurrent or persistent AIDS-related cytomegalovirus (CMV) retinitis.

Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Foscarnet; Ganciclovir; Ganciclovir triphosphate; Phosphonoacetic Acid

Criteria

Inclusion Criteria

Required:

• At least 28 days of prior foscarnet or ganciclovir.

Concurrent Medication:

Allowed:

• G-CSF.

Recommended:

• Antiretroviral therapy.

Patients must have:

• HIV infection or AIDS.

• Active CMV retinitis after 28 or more days of either foscarnet or ganciclovir therapy.

• At least one lesion with one-quarter disk area or more that can be photographed.

• Visual acuity of 3 or more letters on ETDRS chart (5/200 Snellen) in an affected eye.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Media opacity severe enough to preclude visualization of both fundi.

• Retinal detachment not scheduled for surgical repair.

Patients with the following prior conditions are excluded:

• History of intolerance to ganciclovir or foscarnet sufficient to contraindicate use.

• History of combination foscarnet/ganciclovir therapy.

Active drug or alcohol abuse sufficient to prevent compliance.