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

NCT00000136 | Completed Phase 3 Results DMC

• 2 other identifiers: NEI-35U10EY008057
• Study Type: interventional
• Target: 234
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

HIV Infections; Cytomegalovirus Retinitis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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

Drug: Foscarnet; Drug: Ganciclovir

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.

Drug: Foscarnet; Drug: Ganciclovir

Interventions

Foscarnet DRUG

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

Also known as: Foscavir

Foscarnet; Ganciclovir

Ganciclovir DRUG

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

Also known as: Vitraset

Foscarnet; Ganciclovir

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Eye Institute (NEI): collaborator
• Johns Hopkins University: collaborator
• University of Wisconsin, Madison: collaborator
• Baylor College of Medicine: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• New York Presbyterian Hospital: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• NYU Langone Health: collaborator
• Northwestern University: collaborator
• University of California, Los Angeles: collaborator
• University of California, San Diego: collaborator
• University of California, San Francisco: collaborator
• University of Miami: collaborator
• University of Massachusetts, Worcester: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator

Related Publications (13)

• 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.

  PMID: 1315661 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.

  PMID: 8660161 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.

  PMID: 8660169 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.

  PMID: 8660168 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.

  PMID: 9207349 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.

  PMID: 9262538 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.

  PMID: 9222234 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.

  PMID: 1345799 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.

  PMID: 8035989 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.

  PMID: 7658051 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.

  PMID: 7802522 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.

  PMID: 9330549 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.

  PMID: 10980764 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Cytomegalovirus Retinitis

Interventions

Foscarnet; Ganciclovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Eye Infections, Viral; Eye Infections; Cytomegalovirus Infections; Herpesviridae Infections; DNA Virus Infections; Eye Diseases; Retinitis; Retinal Diseases

Intervention Hierarchy (Ancestors)

Phosphonoacetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Organophosphonates; Organophosphorus Compounds; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Curtis Meinert, PhD
• Organization: The Johns Hopkins University

cmeinert@jhsph.edu

410-955-8198

Study Officials

• Curtis Meinert, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 1999
• First Posted: September 24, 1999
• Study Start: March 1, 1990
• Primary Completion: October 1, 1991
• Study Completion: October 1, 1991
• Last Updated: October 22, 2015
• Results First Posted: October 22, 2015

Record last verified: 2015-07