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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

Primary Purpose

Herpes Simplex, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Foscarnet sodium
Sponsored by
Astra USA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring AIDS-Related Opportunistic Infections, Immune Tolerance, Injections, Intravenous, Herpes Simplex, Immunity, Cellular, Foscarnet, Acquired Immunodeficiency Syndrome, Antiviral Agents

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA CARE Ctr
  • Huntington Memorial Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Astra USA
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1. Study Identification

Unique Protocol Identification Number
NCT00002021
Brief Title
An Open Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies
Official Title
An Open Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies
Study Type
Interventional

2. Study Status

Record Verification Date
October 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Astra USA

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Immune Tolerance, Injections, Intravenous, Herpes Simplex, Immunity, Cellular, Foscarnet, Acquired Immunodeficiency Syndrome, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Foscarnet sodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Huntington Memorial Hosp
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8106965
Citation
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 (1988). 1994 Mar;7(3):254-60.
Results Reference
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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

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