Clinical trial NCT00002272: An Open, Multicenter Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies
Official title: An Open, Multicenter Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes Simplex
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Immune Tolerance
Injections, Intravenous
Herpes Simplex
Immunity, Cellular
Drug Resistance
Foscarnet
Acyclovir
Acquired Immunodeficiency Syndrome
Antiviral Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Foscarnet Research Program / Park Plaza Hosp
state: Texas
Study officials:
References:
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.