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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002272
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1990
  Purpose

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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002272

Locations
United States, Texas
Foscarnet Research Program / Park Plaza Hosp
Houston, Texas, United States, 77004
Sponsors and Collaborators
Astra USA
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002272     History of Changes
Other Study ID Numbers: 020G, 89-FOS-09B
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
Drug Resistance
Foscarnet
Acyclovir
Acquired Immunodeficiency Syndrome
Antiviral Agents

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Herpes Simplex
HIV Infections
Immunologic Deficiency Syndromes
Infection
Syndrome
Disease
DNA Virus Infections
Herpesviridae Infections
Immune System Diseases
Lentivirus Infections
Pathologic Processes
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Slow Virus Diseases
Virus Diseases
Acyclovir
Foscarnet
Phosphonoacetic Acid
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014