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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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Simplex; HIV Infections

Intervention: Foscarnet sodium (Drug)

Phase: N/A

Status: Completed

Sponsored by: Astra USA

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.

Clinical Details

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 design: Primary Purpose: Treatment

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): 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.

Locations and Contacts

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

Huntington Memorial Hosp, Pasadena, California 91105, United States

Additional Information

Related 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.


Last updated: June 23, 2005

Page last updated: August 23, 2015

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