Herpes Simplex, HIV Infections
Conditions
Keywords
AIDS-Related Opportunistic Infections, Immune Tolerance, Injections, Intravenous, Herpes Simplex, Immunity, Cellular, Foscarnet, Acquired Immunodeficiency Syndrome, Antiviral Agents
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.
Interventions
DRUGFoscarnet sodium
Sponsors
Astra USA
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed