Search / Trial NCT00000726

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Apply for Trial

Trial Information

Current as of July 14, 2024

Completed

Keywords

Retinitis Aids Related Opportunistic Infections Foscarnet Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antiviral Agents

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 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 vitr...

Gender

All

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.

Attachments

readout_NCT00000726_2024-07-14.pdf

4.5 MB

NCT00000726_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Los Angeles, California, United States

San Francisco, California, United States

New York, New York, United States

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0