Status:
COMPLETED
Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cytomegalovirus Retinitis
HIV Infections
Eligibility:
All Genders
13-65 years
Phase:
PHASE1
Brief Summary
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 p...
Detailed Description
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 polymer...
Eligibility Criteria
Exclusion Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
February 1 1992
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00000726
End Date
February 1 1992
Last Update
November 3 2021
Active Locations (5)
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1
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
2
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, United States, 90033
3
UCLA CARE Ctr
Los Angeles, California, United States, 90095
4
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859