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

Adamas Pharmaceuticals, Inc.2 enrolled

Overview

This Phase 2, open label, randomized study will investigate the virologic benefit, clinical efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (TCAD) versus oseltamivir monotherapy for the treatment of all strains of influenza A in immunocompromised adult and pediatric subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Influenza

Interventions

Oseltamivir PhosphateDRUG

Oseltamivir Phosphate, q8h

ADS-8902DRUG

Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h

Eligibility

Sex: ALLMin age: 1 YearMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed influenza A by rapid antigen testing * Immunocompromised as defined by recent solid organ or hematopoietic transplant, chronic graft vs. host disease, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose chemotherapeutics, HIV positive * Clinical diagnosis of influenza * Onset of illness within 5 days * Male and female subjects agree to contraception through 24 weeks after last dose Exclusion Criteria: * Received more than 1 dose of antiviral agents * Critically ill * Creatinine clearance less than 80 mg/mL * Females who are pregnant and males whose female partners are pregnant * Received live attenuated virus vaccine within 3 weeks

Locations (25)

Adamas Investigational Site

San Francisco, California, United States

Outcomes

Primary Outcomes

Time to clearing of viral shedding

Time frame: Baseline, Days 2, 4, 6, 8, 10, 15 and 20

Secondary Outcomes

Time to alleviation of influenza clinical symptoms

Time frame: Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38

Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza

Time frame: Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38

Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment

Time frame: Baseline, Days 2, 4, 6, 8, 10, 15, 20

Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)

Time frame: Through day 210

Data from ClinicalTrials.gov

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