Foscarnet-Ganciclovir CMV Retinitis Trial

Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)



Sponsors


Source

Johns Hopkins Bloomberg School of Public Health

Oversight Info

Has Dmc

Yes


Brief Summary

To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial
treatment of patients with cytomegalovirus (CMV) retinitis.

Detailed Description

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.

Overall Status

Completed

Start Date

1990-03-01

Completion Date

1991-10-01

Primary Completion Date

1991-10-01

Phase

Phase 3

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Mortality
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.

Enrollment

234

Conditions


Intervention

Intervention Type

Drug

Intervention Name


Description

60 mg/kg every 8 hours, 90 mg/kg/day

Arm Group Label

Foscarnet

Ganciclovir


Other Name

Foscavir


Intervention Type

Drug

Intervention Name


Description

5 mg/kg every 12 hours, 5 mg/kg every 24 hours

Arm Group Label

Foscarnet

Ganciclovir


Other Name

Vitraset



Eligibility

Criteria

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

Gender

All

Minimum Age

13 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Curtis Meinert, PhD
Principal Investigator
Johns Hopkins University

Verification Date

2015-07-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Secondary Id

U10EY008057

Number Of Arms

2

Intervention Browse

Mesh Term

Ganciclovir

Foscarnet

Phosphonoacetic Acid

Ganciclovir triphosphate



Arm Group

Arm Group Label

Foscarnet

Arm Group Type

Experimental

Description

The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day


Arm Group Label

Ganciclovir

Arm Group Type

Experimental

Description

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.



Firstreceived Results Date

N/A

Reference

Citation

Studies of ocular complications of AIDS Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 1. Rationale, design, and methods. AIDS Clinical Trials Group (ACTG). Control Clin Trials. 1992 Feb;13(1):22-39.

PMID

1315661


Citation

Assessment of cytomegalovirus retinitis. Clinical evaluation vs centralized grading of fundus photographs. Studies of Ocular Complications of AIDS Research Group, AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jul;114(7):791-805.

PMID

8660161


Citation

Clinical vs photographic assessment of treatment of cytomegalovirus retinitis. Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial Report 8. Studies of Ocular Complications of AIDS Research Group, AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jul;114(7):848-55.

PMID

8660169


Citation

Wu AW, Coleson LC, Holbrook J, Jabs DA. Measuring visual function and quality of life in patients with cytomegalovirus retinitis. Development of a questionnaire. Studies of Ocular Complication of AIDS Research Group. Arch Ophthalmol. 1996 Jul;114(7):841-7.

PMID

8660168


Citation

Cytomegalovirus (CMV) culture results, drug resistance, and clinical outcome in patients with AIDS and CMV retinitis treated with foscarnet or ganciclovir. Studies of Ocular Complications of AIDS (SOCA) in collaboration with the AIDS Clinical Trial Group. J Infect Dis. 1997 Jul;176(1):50-8.

PMID

9207349


Citation

Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 5. Clinical features of cytomegalovirus retinitis at diagnosis. Studies of ocular complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. Am J Ophthalmol. 1997 Aug;124(2):141-57.

PMID

9262538


Citation

Rhegmatogenous retinal detachment in patients with cytomegalovirus retinitis: the Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. The Studies of Ocular Complications of AIDS (SOCA) Research Group in Collaboration with the AIDS Clinical Trials Group (ACTG). Am J Ophthalmol. 1997 Jul;124(1):61-70.

PMID

9222234


Citation

Studies of Ocular Complications of AIDS Research Group; AIDS Clinical Trials Group. Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. N Engl J Med. 1992 Jan 23;326(4):213-20. Erratum in: N Engl J Med 1992 Apr 23;326(17):1172.

PMID

1345799


Citation

Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. 4. Visual outcomes. Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. Ophthalmology. 1994 Jul;101(7):1250-61.

PMID

8035989


Citation

Antiviral effects of foscarnet and ganciclovir therapy on human immunodeficiency virus p24 antigen in patients with AIDS and cytomegalovirus retinitis. Studies of Ocular Complications of AIDS Research Group in collaboration with AIDS Clinical Trials Group. J Infect Dis. 1995 Sep;172(3):613-21.

PMID

7658051


Citation

Morbidity and toxic effects associated with ganciclovir or foscarnet therapy in a randomized cytomegalovirus retinitis trial. Studies of ocular complications of AIDS Research Group, in collaboration with the AIDS Clinical Trials Group. Arch Intern Med. 1995 Jan 9;155(1):65-74.

PMID

7802522


Citation

Wu AW, Revicki DA, Jacobson D, Malitz FE. Evidence for reliability, validity and usefulness of the Medical Outcomes Study HIV Health Survey (MOS-HIV). Qual Life Res. 1997 Aug;6(6):481-93. Review.

PMID

9330549


Citation

Holbrook JT, Davis MD, Hubbard LD, Martin BK, Holland GN, Jabs DA, Gilpin AK, Meinert C, Reshef DS. Risk factors for advancement of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome. Studies of Ocular Complications of AIDS Research Group. Arch Ophthalmol. 2000 Sep;118(9):1196-204.

PMID

10980764



Acronym

FGCRT

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Single (Outcomes Assessor)


Study First Submitted

September 23, 1999

Study First Submitted Qc

September 23, 1999

Study First Posted

September 24, 1999

Last Update Submitted

September 22, 2015

Last Update Submitted Qc

September 22, 2015

Last Update Posted

October 22, 2015

Results First Submitted

June 22, 2015

Results First Submitted Qc

September 22, 2015

Results First Posted

October 22, 2015


ClinicalTrials.gov processed this data on August 24, 2018

Conditions

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Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

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In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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