Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome

Completed · Phase 1

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

To explore the safety and usefulness of foscarnet, an antiviral agent, in the treatment of cytomegalovirus (CMV) retinitis. Untreated CMV retinitis is a rapidly progressive, blinding disease in AIDS patients. The manner in which foscarnet breaks down in the body and the effect of increasing periodic intravenous doses are also studied. Foscarnet is active in vitro (test tube) against herpes viruses, including CMV, by inhibiting the virus DNA polymerases, enzymes necessary for virus replication, without affecting cellular DNA polymerases. Opportunistic CMV disease in AIDS is usually seen as retinitis, colitis, esophagitis, hepatitis, pancreatitis, encephalitis, or pneumonia. Ganciclovir has been used to treat AIDS patients with CMV disease but can cause severe neutropenia (very low neutrophil cell counts). Foscarnet does not suppress the production of neutrophils or other leukocytes (myelosuppression) and has shown in vitro activity against HIV.

Key facts

Study ID

NCT00000726

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

53

Expected to finish

1992-02-01

Last updated by the study team

2021-11-03

Who can join

Age: 13 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Concurrent Medication:
• Excluded:
• Acyclovir.
• Zidovudine (AZT).
• Any potentially nephrotoxic agent, especially aminoglycosides, pentamidine, or amphotericin B.
• Prior Medication:
• Excluded:
• Ganciclovir.
• Foscarnet.
• Excluded within 7 days of study entry:
• Any potentially nephrotoxic agent.
• Excluded within 14 days of study entry:
• Cytomegalovirus hyperimmune globulin in therapeutic doses.
• Immunomodulators.
• Biologic response modifiers.
• Investigational agents.
• Amphotericin B maintenance for a systemic mycosis.
• Known allergy to foscarnet.
• Active AIDS-defining opportunistic infection other than cytomegalovirus (CMV) including systemic mycosis, pulmonary or neurologic impairment (comatose).
• Patient must be diagnosed as having:
• AIDS CDC Group IV.C.
• Cytomegalovirus (CMV) retinitis as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography.
• One pending culture for CMV from blood and urine prior to study entry.

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• USC School of Medicine / Norris Cancer Hosp — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States
• Mem Sloan - Kettering Cancer Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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