Completed

Foscarnet Treatment for Acyclovir-Resistant Herpes Simplex Virus in Immunocompromised Patients

What is being tested

Foscarnet sodium

Drug

Who is being recruted

Blood-Borne Infections+22

+ Urogenital Diseases

+ Genital Diseases

Over 12 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

See protocol details

Summary

Principal SponsorAstra USA

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

This study focuses on the treatment of herpes simplex virus (HSV) infections that are resistant to a common medication called acyclovir. It involves patients diagnosed with Acquired Immunodeficiency Syndrome (AIDS) and other conditions that weaken the immune system. The main goal is to assess the safety and effectiveness of a drug named foscarnet, administered intermittently through intravenous (IV) infusion. The importance of this study lies in its potential to provide a new treatment option for patients dealing with acyclovir-resistant HSV infections, a condition that currently poses significant challenges due to limited treatment options. During the study, participants receive foscarnet treatment through IV infusion at intervals. The study aims to understand if this intermittent dosing can effectively manage acyclovir-resistant HSV infections. Additionally, it seeks to determine if continued IV maintenance therapy with foscarnet can prevent the recurrence of the disease. The study also investigates how the body responds to foscarnet when given in these intermittent induction and maintenance IV regimens, further contributing to the understanding of this treatment approach.

NCT00002272

Principal SponsorAstra USA

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSkin DiseasesSkin Diseases, InfectiousSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsSkin Diseases, ViralSkin and Connective Tissue DiseasesAcquired Immunodeficiency SyndromeHerpes SimplexHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

4 inclusion criteria required to participate

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.

Expected survival of at least 6 months.

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.

6 exclusion criteria prevent from participating

Biologic response modifiers within 14 days of entry.

Immunomodulators within 14 days of entry.

Any potentially nephrotoxic agent (except cyclosporine) within 7 days of entry.

Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Foscarnet Research Program / Park Plaza Hosp

Houston, United StatesOpen Foscarnet Research Program / Park Plaza Hosp in Google Maps

CompletedOne Study Center