Phase 3
N=61
Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)
Cytomegalovirus Retinitis · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00000143 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Survival — 31; 30 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ganciclovir implant and oral ganciclovir (Device); Cidofovir intravenous (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Jun 2000
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival |
31; 30 | — |
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.
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
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.