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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Herpes Simplex, HIV Infections

Intervention / Treatment
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* Drug: Foscarnet sodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Foscarnet sodium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS-Related Opportunistic Infections, Immune Tolerance, Injections, Intravenous, Herpes Simplex, Immunity, Cellular, Drug Resistance, Foscarnet, Acyclovir, Acquired Immunodeficiency Syndrome, Antiviral Agents