Pharmacodynamic relationship of pharmacokinetic parameters of maintenance doses of foscarnet and clinical outcome of cytomegalovirus retinitis.
M A Jacobson, B Polsky, D Causey...
https://pubmed.ncbi.nlm.nih.gov/8067763Completed
Phase 1
Age: 13Years - 65Years
All Genders
ID00000726
Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-03
53
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
Who Can Participate
Age: 13Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 5 locations
1
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Status Unknown
2
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, United States, 90033
Status Unknown
3
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Status Unknown
4
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
5
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Pharmacokinetics of intermittently administered intravenous foscarnet in the treatment of acquired immunodeficiency syndrome patients with serious cytomegalovirus retinitis.
F Aweeka, J Gambertoglio, J Mills...
https://pubmed.ncbi.nlm.nih.gov/2546491Foscarnet treatment of cytomegalovirus retinitis in patients with the acquired immunodeficiency syndrome.
M A Jacobson, J J O'Donnell, J Mills
https://pubmed.ncbi.nlm.nih.gov/2546490Effect of Foscarnet therapy on infection with human immunodeficiency virus in patients with AIDS.
M A Jacobson, S Crowe, J Levy...
https://pubmed.ncbi.nlm.nih.gov/2844921A dose-ranging study of daily maintenance intravenous foscarnet therapy for cytomegalovirus retinitis in AIDS.
M A Jacobson, D Causey, B Polsky...
https://pubmed.ncbi.nlm.nih.gov/8393058