Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: PREVAIL IV: Double-Blind, Randomized, Two-Phase, Placebo-Controlled, Phase II Trial of GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and
Brief Summary:
Background:
Some people have Ebola virus in their body for months after they recover from Ebola virus disease. Some may have health problems from the virus while others are fine. These people may be able to pass the virus to others. There are currently no drugs for people who have survived Ebola virus disease but still have the virus in their body. A new drug, GS-5734, might help get rid of Ebola virus in semen.
Objective:
To test if GS-5734 helps get rid of Ebola virus in semen and is safe for humans.
Eligibility:
Men who participated in the Ebola survivor study (PREVAIL III) and have evidence of the Ebola virus in their semen
Design:
Participants will be screened with:
Questions
Physical exam
Eye exam
Blood tests
2 semen samples if they have not had it tested recently
Participants must live near the study site in Liberia for 6 months.
Participants will be put into 1 of 2 study groups. They will have an infusion of either GS-5734 or a placebo every day for 5 days. A plastic tube is put into an arm vein. The infusion lasts 1 hour.
Participants will be observed for 1 hour after. They will provide a semen sample on infusion day 4.
After t