Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U10EY008057 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| Johns Hopkins University | OTHER |
| University of Wisconsin, Madison | OTHER |
| Baylor College of Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foscarnet | Experimental | The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day |
|
| Ganciclovir | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foscarnet | Drug | 60 mg/kg every 8 hours, 90 mg/kg/day |
|
| Measure | Description | 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. |
Not provided
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Curtis Meinert, PhD | Johns Hopkins University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1315661 | Background | 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. doi: 10.1016/0197-2456(92)90027-w. | |
| 8660161 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Foscarnet | The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours |
| FG001 | 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. Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Foscarnet | The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours |
| BG001 | Ganciclovir |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | Posted | Number | participants | 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. |
|
1 year, 7 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Foscarnet | The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Opportunistic Infection | Immune system disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Curtis Meinert, PhD | The Johns Hopkins University | 410-955-8198 | cmeinert@jhsph.edu |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D017726 | Cytomegalovirus Retinitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| D017245 | Foscarnet |
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D010746 | Phosphonoacetic Acid |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
| OTHER |
| Louisiana State University Health Sciences Center in New Orleans | OTHER |
| New York Presbyterian Hospital | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
| NYU Langone Health | OTHER |
| Northwestern University | OTHER |
| University of California, Los Angeles | OTHER |
| University of California, San Diego | OTHER |
| University of California, San Francisco | OTHER |
| University of Miami | OTHER |
| University of Massachusetts, Worcester | OTHER |
| Memorial Sloan Kettering Cancer Center | OTHER |
Not provided
Not provided
Not provided
Not provided
| Ganciclovir | Drug | 5 mg/kg every 12 hours, 5 mg/kg every 24 hours |
|
|
| 8660169 | Background | 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. |
| 8660168 | Background | 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. doi: 10.1001/archopht.1996.01100140055008. |
| 9207349 | Background | 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. doi: 10.1086/514039. |
| 9262538 | Background | 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. |
| 9222234 | Background | 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. |
| 1345799 | Background | 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. doi: 10.1056/NEJM199201233260401. |
| 8035989 | Background | 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. |
| 7658051 | Background | 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. doi: 10.1093/infdis/172.3.613. |
| 7802522 | Background | 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. |
| 9330549 | Background | 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. doi: 10.1023/a:1018451930750. |
| 10980764 | Background | 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. doi: 10.1001/archopht.118.9.1196. |
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. Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 60 |
| 107 |
| 0 |
| 107 |
| EG001 | 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. Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours | 73 | 127 | 0 | 127 |
Not provided
Not provided
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D003586 | Cytomegalovirus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D005128 | Eye Diseases |
| D012173 | Retinitis |
| D012164 | Retinal Diseases |
| D009930 |
| Organic Chemicals |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |