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


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Acyclovir

Zovirax 




Clinical Trial: An Open 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.

Sponsored by: Astra USA
Information provided by: AIDS Clinical Trials Information Service

Purpose

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.

Condition Treatment or Intervention
Herpes Simplex
HIV Infections
 Drug: Foscarnet sodium

MedlinePlus related topics:  AIDS;   Herpes Simplex

Study Type: Interventional
Study Design: Treatment

Eligibility

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

  • Cyclosporine.

Patients must have AIDS as defined by the CDC or be immunocompromised (transplant patients; other hematologic malignancies with recognized cell-mediated immune deficiency). Patients must also 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. Patients must have expected survival of at least 6 months.

Prior Medication: Allowed:

  • Cyclosporin.
  • 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 study entry:

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

Location Information


California
      UCLA CARE Ctr, Los Angeles,  California,  90095,  United States

      Huntington Memorial Hosp, Pasadena,  California,  91105,  United States

More Information

Publications

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.

Study ID Numbers:  020F; 89-FOS-09A
Record last reviewed:  October 1990
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002021
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: October 1, 2005
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