Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component
3 other identifiers
interventional
240
1 country
9
Brief Summary
To evaluate the relative effectiveness and safety of foscarnet versus ganciclovir for the treatment of cytomegalovirus (CMV) retinitis in people with AIDS; to evaluate the relative effect on survival of the use of these two anti-CMV agents in the treatment of CMV retinitis; to compare the relative benefits of immediate treatment with foscarnet or ganciclovir versus deferral of treatment for CMV retinitis limited to less than 25 percent of zones 2 and 3. CMV retinitis is a common opportunistic infection in patients with AIDS. Ganciclovir is currently the only drug approved for treatment of CMV retinitis in immunocompromised patients. Ganciclovir suppresses CMV infections, and relapse occurs in virtually all AIDS patients when ganciclovir is discontinued. Because of their similar hematologic (blood) toxicities, the simultaneous use of ganciclovir and zidovudine (AZT) is not recommended. More recently the drug foscarnet has become available for investigational use. Studies so far indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients, and that relapse occurs in virtually all patients when the drug is discontinued. The relative effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV infections is unknown. Further, the long-term effects of foscarnet or ganciclovir on CMV retinitis, survival, and morbidity are unknown. There is also no definitive information on the relative effectiveness and safety of deferred versus immediate treatment for CMV retinitis confined to zones 2 and 3.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
9 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
April 1, 1992
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 14, 2011
December 1, 1994
November 2, 1999
March 11, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Topical anti-Herpesvirus agents.
- Zidovudine (AZT) for patients in deferral or foscarnet treatment groups:
- mg every 4 hours. For patients on ganciclovir:
- mg every 8 hours.
- Dideoxyinosine (ddI) and other antiretroviral available via expanded access programs, investigational triazoles, granulocyte-macrophage colony-stimulating factor, and erythropoietin to treat marrow toxicity. The use of other investigational drugs will be considered on a drug by drug basis.
- It is not recommended that patients receiving ganciclovir take AZT simultaneously. If AZT is prescribed for patients taking ganciclovir, it should be prescribed at reduced doses and discontinued if hematologic toxicity develops.
- Patients must have:
- Diagnosis of AIDS by CDC criteria or a documented HIV infection.
- Cytomegalovirus (CMV) retinitis that does not require surgical intervention diagnosed in one or both eyes by a SOCA-certified ophthalmologist.
- The means available for compliance with follow-up visits (including a caregiver if necessary).
- Must consent to study or consent of parent or guardian if less than 18 years of age.
- Willingness to take reduced dose of zidovudine (AZT) if dictated by treatment assignment.
- Willingness to discontinue other systemic treatments for Herpesvirus infections while receiving foscarnet or ganciclovir.
- +3 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Sufficient media opacities to preclude fundus photographs in both eyes.
- Concurrent Medication:
- Excluded:
- Other systemic treatments for Herpesvirus infections.
- Other anti-cytomegalovirus therapy.
- Excluded with foscarnet:
- Parenteral pentamidine, amphotericin B, or aminoglycosides.
- Use of marrow toxic agents with ganciclovir and nephrotoxic agents with foscarnet is discouraged, and alternative treatment should be used whenever possible.
- Patients with the following are excluded:
- Sufficient media opacities to preclude fundus photographs in both eyes.
- Known or suspected allergy to one of the study medications.
- Prior Medication:
- Excluded:
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, 920930946, United States
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, 900957003, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94143, United States
Northwestern Univ / SOCA
Chicago, Illinois, 60611, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hosp / SOCA
Baltimore, Maryland, 212879217, United States
New York Univ Med Ctr / SOCA
New York, New York, 10016, United States
New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA
New York, New York, 10021, United States
Mount Sinai Med Ctr / SOCA
New York, New York, 100296574, United States
Related Publications (3)
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: 1315661BACKGROUNDStudies 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: 1345799BACKGROUNDHolbrook JT, Jabs DA, Weinberg DV, Lewis RA, Davis MD, Friedberg D; Studies of Ocular Complications of AIDS (SOCA) Research Group. Visual loss in patients with cytomegalovirus retinitis and acquired immunodeficiency syndrome before widespread availability of highly active antiretroviral therapy. Arch Ophthalmol. 2003 Jan;121(1):99-107. doi: 10.1001/archopht.121.1.99.
PMID: 12523893BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
April 1, 1992
Last Updated
March 14, 2011
Record last verified: 1994-12