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
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