Phase 3 Completed N=61 Randomized Treatment

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

Cytomegalovirus retinitis · HIV

Source: ClinicalTrials.gov NCT00000143 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcomePrimary: Survival — 31; 30 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Survival	31; 30	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00000143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.