Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)