Search / Trial NCT00000985

Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients With AIDS Who Have Not Had Success With Acyclovir

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

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Vidarabine Phosphonoacetic Acid Herpes Simplex Foscarnet Acyclovir Acquired Immunodeficiency Syndrome

Description

Foscarnet is a drug that inhibits viruses and has been shown to be effective against infection with Cytomegalovirus and also against infection with the Herpes simplex virus in several patients with AIDS. Vidarabine has been shown to have activity against the Herpes simplex virus in patients who do not have AIDS, but it has not been studied in patients who do have AIDS. This study compares foscarnet and vidarabine treatments for AIDS patients who have herpes simplex infection that has not responded to therapy with acyclovir in the hope that one of these two drugs will help to stop further pr...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed for phase B:
  • Aerosolized pentamidine prophylaxis for Pneumocystis carinii pneumonia (PCP).
  • Prior Medication:
  • Allowed for phase A:
  • Ganciclovir. Patients receiving this drug at the time of study enrollment must discontinue the drug at the time of enrollment and for the duration of the study period.
  • Exclusion Criteria
  • Co-existing Condition:
  • For phase A, patients with pre-existing severe neurologic impairment such as seizure disorder or marked or incapacitating ataxia are excluded.
  • Concurrent Medication:
  • Excluded upon entry into phase B:
  • Ganciclovir.
  • Immunomodulators.
  • Probenecid.
  • Ciprofloxacin.
  • Allopurinol.
  • Zidovudine (AZT).
  • Antiretrovirals.
  • Other investigational agents.
  • Acyclovir for another labeled indication.
  • Potentially nephrotoxic agents.
  • Patients will be excluded from the study for the following reasons:
  • Phase A:
  • Previous hypersensitivity reaction to foscarnet or vidarabine. Patients who have a documented history of vidarabine intolerance may be eligible for the foscarnet on the non-randomized arm of the study.
  • Phase B:
  • Clinical response to therapy with acyclovir in phase A described as "healed" or "good."
  • Prior Medication:
  • Excluded within 14 days of study entry:
  • Immunomodulators or biologic response modifiers.
  • Phase A:
  • Excluded within 30 days of study entry:
  • Foscarnet.
  • Phase B:
  • Excluded within 7 days of study entry into phase B:
  • Any potentially nephrotoxic agent, except acyclovir.
  • Prior Treatment:
  • Excluded for phase A within 14 days of study entry:
  • Lymphocyte replacement therapy.
  • Patients must demonstrate the following clinical and laboratory findings:
  • Phase A:
  • HIV positive by federally licensed ELISA test confirmed by Western blot, p24 serum antigen, or a positive HIV culture; or a prior diagnosis of AIDS as defined by Centers for Disease Control criteria.
  • Mucocutaneous herpes simplex virus (HSV) infection confirmed by viral culture persisting for a minimum of 2 weeks which is clinically resistant to therapy with acyclovir in the opinion of the patient's physician.
  • Phase B:
  • Persistent shedding of HSV at the completion of or within 1 week after completion of phase A acyclovir therapy as confirmed by viral culture.
  • Documented in vitro resistance of the virus to acyclovir.
  • All strains must be referred to the Diagnostic Virology Laboratories at either San Francisco General Hospital or Beth Israel Hospital, Boston, for susceptibility testing.
  • Two serum acyclovir levels drawn during phase A. Results may be pending at time of entry into phase B.
  • All eligibility evaluations must be performed within 7 days prior to study entry for phase A or B.

Attachments

readout_NCT00000985_2023-12-10.pdf

4.5 MB

NCT00000985_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

Chicago, Illinois, United States

Boston, Massachusetts, United States

Rochester, New York, United States

Seattle, Washington, 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

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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?

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