Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects

Phase 2

• Conditions: Influenza A; Immune compromised; Infection - Other infectious diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12609000708257
• Lead Sponsor: Adamas Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Immunocompromised as defined by one of either: recent solid organ or hematopoietic cell transplantation, chronic Graft Versus Host Disease (GVHD) requiring systemic immunosuppression, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose corticosteroids or Human Immunodeficiency Virus (HIV) positive.

Clinical diagnosis of Influenza A infection (mild.moderate or severe)

Onset of illness no more than 3 days prior to study entry.

Subjects (Male and Female) agree to use contraception through 24 weeks after last dose.

Exclusion Criteria

Use of more than 2 doses of antiviral influenza medications since onset of symptoms

Critically ill

Creatinine Clearance less than 30 mL/min

Known genetic hemoglobinopathy

Presence of suspected or diagnosed non influenza infection requiring treatment.

Pschyatric or cognitive illness or recreational drug/alcohol use that would affect patient safety and compliance.

Documented non-influenza viral infection, including respiratory syncytial virus or Influenza B

Women who are pregnant, who are attempting to become pregnant, or who are breast-feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified