Tolerance and Activity Evaluation of High Doses of Favipiravir Against Ebola Virus in the Semen

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study aims to evaluate favipiravir high dose tolerance in male survivor of Ebola Virus Disease (EVD) with Ebola Virus (EBOV) RNA in semen. This is a dose escalation study with 3 cohorts of 6 patients, each dose level including 2 sentinel patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Favipiravir

Criteria

Inclusion Criteria:

• male survivor of biologically confirmed EVD

• age >= 18 years

• EBOV RT-PCR on semen with cycle threshold [Ct]<38 at Day -7 and semen aliquot available for later quantification of EBOV

• signed informed consent

Non-Inclusion Criteria:

• EBOV RT-PCR on blood with cycle threshold [Ct]<38 at Day -7

• Biological abnormality higher than grade 2 according to CTCAE (v4.03) on following parameters: creatinine, ASAT, ALAT, alkaline phosphatase, total bilirubin

• Fridericia corrected QT interval (QTc) > 450 ms

• Concomitant use of QT/QTc interval-prolonging drugs or drugs that could cause electrolyte imbalance, such as: loop diuretics, thiazide diuretics or related

• Previous gout attack or ongoing treatment for gout or hyperuricemia

• Ongoing pyrazinamide treatment or other drug known to induce hyperuricemia

• Previous hypersensitivity reaction due to nucleoside analogue

• Symptom or biological value suggesting systemic disorder (renal, hepatic, cardio-vascular, pulmonary) or any medical condition that could interfere with results interpretation or compromise participants' health

• Explicit refusal to comply with proper use of drug (condom use)