Search / Trial NCT00002021

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

Launched by ASTRA USA · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Aids Related Opportunistic Infections Immune Tolerance Injections, Intravenous Herpes Simplex Immunity, Cellular Foscarnet Acquired Immunodeficiency Syndrome Antiviral Agents

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • 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.

About Astra Usa

Astra USA, a subsidiary of AstraZeneca, is a leading biopharmaceutical company dedicated to the research, development, and commercialization of innovative medicines that address unmet medical needs across various therapeutic areas, including oncology, cardiovascular, and respiratory diseases. With a strong commitment to advancing healthcare, Astra USA leverages cutting-edge science and technology to deliver high-quality treatments and improve patient outcomes. The organization emphasizes collaboration with healthcare professionals, regulatory bodies, and patient communities to ensure the safety and efficacy of its clinical trials, ultimately striving to enhance the quality of life for patients globally.

Locations

Los Angeles, California, United States

Pasadena, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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