Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT) (FGCRT)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00000136 |
|
Recruitment Status :
Completed
First Posted : September 24, 1999
Results First Posted : October 22, 2015
Last Update Posted : October 22, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections Cytomegalovirus Retinitis | Drug: Foscarnet Drug: Ganciclovir | Phase 3 |
CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. The first two drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). At the time of this trial, both ganciclovir and foscarnet were available only as intravenous formulations. Both drugs were given in a similar two-step fashion: an initial 2-week course of high-dose therapy (induction) to control the infection followed by long-term lower dose therapy to prevent relapse (maintenance). The FGCRT compared foscarnet and ganciclovir as initial therapy for CMV retinitis.
The FGCRT was a multicenter, randomized, controlled clinical trial comparing foscarnet and ganciclovir as initial therapy for CMV retinitis. Patients with previously untreated CMV retinitis were randomized to therapy with either intravenous ganciclovir or intravenous foscarnet. The outcome measures of this trial were survival, retinitis progression, loss of visual function (visual acuity and visual field), and morbidity.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 234 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Foscarnet-Ganciclovir CMV Retinitis Trial |
| Study Start Date : | March 1990 |
| Actual Primary Completion Date : | October 1991 |
| Actual Study Completion Date : | October 1991 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Foscarnet
The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day
|
Drug: Foscarnet
60 mg/kg every 8 hours, 90 mg/kg/day
Other Name: Foscavir Drug: Ganciclovir 5 mg/kg every 12 hours, 5 mg/kg every 24 hours
Other Name: Vitraset |
|
Experimental: Ganciclovir
The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.
|
Drug: Foscarnet
60 mg/kg every 8 hours, 90 mg/kg/day
Other Name: Foscavir Drug: Ganciclovir 5 mg/kg every 12 hours, 5 mg/kg every 24 hours
Other Name: Vitraset |
- Mortality [ Time Frame: All patients enrolled will be followed until a common study closing date, which was chosen to provide a minimum of 1 year of follow-up for all patients enrolled in the trial. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- CMV retinitis in one or both eyes
- At least 1/4 disk are of one CMV lesion photographable
- Diagnosis of AIDS as defined by Center for Disease Control criteria or documented HIV infection
- Age 13 and greater
- Visual acuity ≥ 3/200 in at least one eye diagnosed with CMV retinitis
- Absolute neutrophil count ≥ 1,000 cells/µl
- Platelet ≥ 25,000 cells/µl
- Serum creatinine ≥ 2.0 mg/dl
- Karnofsky score ≥ 60
- Informed consent
Exclusion criteria:
- Previous treatment of CMV retinitis
- Treatment with anti-CMV therapy for an extra-ocular CMV infection currently or in the past 28 days
- Known or suspected allergy to study drugs
- Pregnant or Lactating
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000136
| Principal Investigator: | Curtis Meinert, PhD | Johns Hopkins University |
Publications:
| Responsible Party: | Johns Hopkins Bloomberg School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00000136 |
| Other Study ID Numbers: |
NEI-35 U10EY008057 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 24, 1999 Key Record Dates |
| Results First Posted: | October 22, 2015 |
| Last Update Posted: | October 22, 2015 |
| Last Verified: | July 2015 |
|
Cytomegalovirus Retinitis Retinitis Infections Virus Diseases Retinal Diseases Eye Diseases Eye Infections, Viral Eye Infections Cytomegalovirus Infections Herpesviridae Infections |
DNA Virus Infections Ganciclovir Ganciclovir triphosphate Foscarnet Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors |