MedTrace Logo

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

NCT00000143 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2016-03-14

Study results available
· View outcomes & findings →

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.

Conditions

  • Cytomegalovirus Retinitis
  • HIV Infections

Interventions

DEVICE

Ganciclovir implant and oral ganciclovir

oral ganciclovir, 1 gm three times daily

DRUG

Cidofovir intravenous

intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week

Sponsors & Collaborators

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Douglas Jabs, MD · SOCA Chairman's Office

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-05-31
Primary Completion
2000-06-30
Completion
2000-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000143 on ClinicalTrials.gov