Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT) (NCT00000142) | Clinical Trial Compass
CompletedPhase 2/3
Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT)
64 participantsStarted 1994-04
Plain-language summary
To test and evaluate the efficacy and safety of intravenous cidofovir (Vistide, previously known as HPMPC) for the treatment of retinitis.
Who can participate
Age range13 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* diagnosis of AIDS according to the Centers for Disease Control and Prevention (CDC)
* 13 years or older
* Diagnosis of CMV (cytomegalovirus) retinitis as determined by a SOCA-certified Ophthalmologist.
* At least one lesion whose size is one-quarter disc area or more that can be photographed.
* Visual acuity in an affected eye of 3 or more lines on the (ETDRS) Early Treatment Diabetic Retinopathy Study chart at 1 meter distance (Snellen equivalent 8/200).
* score of 60 or more on the Karnofsky scale.
* Serum creatinine of 1.5mg/dL or less
* less than 1+ proteinuria on urinalysis
* Total bilirubin of 3.0 mg/dL or less
* Hepatic transaminase levels that do not exceed 5 times the normal levels
* Absolute neutrophil count of 750 cells/µL or greater
* Platelet count of 50,000 cells/µL or greater
* Hemoglobin of 7.5 g/dL or greater
* Negative pregnancy test (females of childbearing potential)
* All men/women of childbearing potential should practice birth control to prevent pregnancy while on study and for 3 months afterwards
* Willingness/ability, with the assistance of a caregiver if necessary to comply with treatment and follow-up procedures
* Signed consent statement
Exclusion criteria:
* Evidence of a CMV (cytomegalovirus) retinitis lesion within zone 1. A lesion less than 1,500 µ from the margin of the optic disc or less than 3,000 µ from the center of the fovea in either eye excludes a patient.
* Evidence of a CMV retinitis lesions that involves 25% …
What they're measuring
1
Survival
Timeframe: All patients enrolled will be followed until a common study closing date
Trial details
NCT IDNCT00000142
SponsorJohns Hopkins Bloomberg School of Public Health