An Open Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies
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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.
Condition | Intervention |
---|---|
Herpes Simplex HIV Infections |
Drug: Foscarnet sodium |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | An Open Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts 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.
Publications:
ClinicalTrials.gov Identifier: | NCT00002021 History of Changes |
Other Study ID Numbers: | 020F, 89-FOS-09A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Immune Tolerance Injections, Intravenous Herpes Simplex |
Immunity, Cellular Foscarnet Acquired Immunodeficiency Syndrome Antiviral Agents |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Herpes Simplex Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral |
Skin Diseases, Infectious Skin Diseases Acyclovir Foscarnet Phosphonoacetic Acid Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on March 10, 2013