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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00000726

First received: November 2, 1999
Last updated: March 28, 2012
Last Verified: March 2012
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Cytomegalovirus Retinitis
HIV Infections

Drug : Foscarnet sodium
Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 53
Study Completion Date: February 1992

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 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.
Treatment is given for a total of 10 weeks with a 2-week induction regimen followed by randomization to daily maintenance foscarnet for 8 weeks. If induction therapy is tolerated without unexpected toxicity, patients are allowed to self-administer foscarnet at home via central venous catheter and may receive up to 11 days of induction therapy by self-administration on an outpatient basis. Foscarnet will be administered in open-label fashion so that both investigator and patient will know the dose. Within the study, there are 8 patients who upon entering the 2nd week of maintenance foscarnet therapy are treated with zidovudine (AZT).

Eligibility

Eligibility

Ages Eligible for Study: 13 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000726

Locations

United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, United States, 90033
UCLA CARE Ctr
Los Angeles, California, United States, 90095
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
United States, New York
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: Jacobson M
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00000726   History of Changes  
Other Study ID Numbers: ACTG 015  
  FDA 20D  
  10991  
Study First Received: November 2, 1999  
Last Updated: March 28, 2012  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Retinitis
AIDS-Related Opportunistic Infections
Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Antiviral Agents

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Retinitis
Cytomegalovirus Retinitis
Foscarnet
Phosphonoacetic Acid

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.