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

Astra USA

Status: Completed

Conditions: Herpes Simplex; HIV Infections

Treatments: Drug: Foscarnet sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002272

89-FOS-09B

020G

Details and patient eligibility

About

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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.