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Clinical Trials

MainTitle

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
Astra USA


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002272

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: September 1990
History of Changes
Purpose

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

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

Eligibility

Eligibility

Ages Eligible for Study: 12 Years and older  
Sexes Eligible for Study: All  
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

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

More Information


Responsible Party: Astra USA  
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  

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:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Herpes Simplex
Acyclovir
Foscarnet
Phosphonoacetic Acid

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.