Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects (PO206)

Adamas Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Drug: ADS-8902; Drug: Oseltamivir Phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00979251

ADS-TCAD-PO206

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 1 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

ADS-8902

Experimental group

Description:

Amantadine and Ribavirin administered with Oseltamivir phosphate

Treatment:

Drug: ADS-8902

Comparator

Active Comparator group

Description:

Oseltamivir Phosphate

Treatment:

Drug: Oseltamivir Phosphate