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

Launched by JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH · Sep 23, 1999

Keywords

ClinConnect Summary

Cytomegalovirus (CMV) is among the most frequently encountered opportunistic infections in patients with AIDS. In the era of prophylaxis for pneumocystic pneumonia, CMV disease is estimated to affect 45 percent of patients with AIDS sometime between the diagnosis of AIDS and death. Retinitis has been estimated to account for up to 85 percent of CMV disease in these patients, making CMV retinitis the most common ocular infection encountered. CMV retinitis is a relatively late-stage manifestation, associated with cluster of differentiation 4 (CD4) + T-cell counts \< 100 cells/µL and often \< ...

Gender

ALL

Eligibility 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