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

Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2016-03-14

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 13Years +

All Genders

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

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