Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)

• Status: Completed
• Trial end date: 2000-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the newest CMV retinitis drug, cidofovir, with a regimen of the ganciclovir intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss.

To compare a treatment regimen that incorporates highly active local therapy (ganciclovir device) with a treatment regimen that does not.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health
• Treatments: Cidofovir; Ganciclovir; Ganciclovir triphosphate

Criteria

Inclusion criteria:

• Age 13 years or older

• Diagnosis of AIDS according to current Centers for Disease Control and Prevention (CDC) definition

• Diagnosis of active CMV retinitis by a SOCA-certified ophthalmologist (involvement of any zone or amount of retina is allowed)

• Best corrected visual acuity of 20/100 or better in at least one eye

• At least one lesion 750 cells/µL or greater

• Platelet count 50,000 cells/µL or greater

• Willingness and ability, with the assistance of a caregiver if necessary to comply with treatment and follow up procedures

• Willingness of all men and women of childbearing potential to practice adequate birth control to prevent pregnancies during the study and for 3 months afterwards

• Collection of all baseline data within 5 days prior to randomization

• Signed consent statement

Exclusion criteria:

• Media opacities that preclude visualization of the fundus of all otherwise eligible eyes

• Treatment for CMV retinitis with the ganciclovir intraocular implant within 9 months of study entry

• Medical problems or drug or alcohol abuse sufficient to hinder adherence to treatment or follow up procedures

• Unwillingness to refrain from breast-feeding during the study and for 3 months afterwards