An Open, Multicenter Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002272
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1990

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002272 on ClinicalTrials.gov Archive Site
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An Open, Multicenter Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies
An Open, Multicenter Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies

To evaluate the safety and efficacy of intermittent intravenous (IV) foscarnet in the treatment of acyclovir-resistant herpes simplex virus (HSV) infections in AIDS patients and other immunocompromised patients. To evaluate the necessity, efficacy, and safety of IV maintenance foscarnet therapy in preventing recurrent disease. To confirm the pharmacokinetics of intermittent induction and maintenance IV regimens.

Not Provided
Interventional
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Primary Purpose: Treatment
  • Herpes Simplex
  • HIV Infections
Drug: Foscarnet sodium
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Balfour HH Jr, Benson C, Braun J, Cassens B, Erice A, Friedman-Kien A, Klein T, Polsky B, Safrin S. Management of acyclovir-resistant herpes simplex and varicella-zoster virus infections. J Acquir Immune Defic Syndr. 1994 Mar;7(3):254-60. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria

Concurrent Medication:

Allowed:

  • Cyclosporine.

Patients must have AIDS as defined by the CDC, or be patients with other immunocompromised states (transplant patients; other hematologic malignancies with recognized cell-mediated immune deficiency), and have herpes simplex virus (HSV) infection documented by culture and in vitro resistance to acyclovir by standard laboratory susceptibility or suspected resistance to acyclovir after an acyclovir treatment failure in which acyclovir was administered for at least 2 weeks intravenously at doses of 30 mg/kg/day (or a comparative dose adjusted for renal insufficiency). In vitro susceptibility data must be pending in the latter case.

  • Patients must be able to give informed consent.
  • Patients < 18 years of age may participate with the consent of parent, guardian, or person with power of attorney, or through the provisions of state laws regarding emancipated minors.
  • Expected survival of at least 6 months.

Prior Medication:

Allowed:

  • Cyclosporine.
  • Ganciclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Known allergy to foscarnet.
  • Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).

Concurrent Medication:

Excluded:

  • Any potentially nephrotoxic agent (except cyclosporine).
  • Immunomodulators.
  • Biologic response modifiers.
  • Investigational agents.

Patients with the following are excluded:

  • Known allergy to foscarnet.
  • Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).

Prior Medication:

Excluded within 7 days of entry:

  • Any potentially nephrotoxic agent (except cyclosporine).
  • Excluded within 14 days of entry:
  • Immunomodulators.
  • Biologic response modifiers.
  • Investigational agents.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002272
020G, 89-FOS-09B
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Astra USA
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NIH AIDS Clinical Trials Information Service
September 1990

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP