Via JAMA: Trial Launched to Eradicate Ebola From Semen.
The Partnership for Research on Ebola Virus in Liberia (PREVAIL), a US-Liberia joint clinical research partnership, recently announced the opening of PREVAIL IV, a trial for male Ebola survivors with persistent Ebola virus RNA in their semen (http://bit.ly/29OtRa9). The trial is sponsored by the National Institute of Allergy and Infectious Diseases in partnership with the Ministry of Health of Liberia and Gilead Sciences. The six-month randomized, double-blind study will enroll 60 to 120 male Ebola survivors whose semen tested positive for Ebola virus RNA.
Participants will be randomized to receive either 100 mg of investigational drug GS-5734 or placebo once daily by intravenous catheter for 5 days. Antiviral activity, as well as safety and tolerability, will be evaluated over 28 days following administration of the drug or placebo. Longer-term clearance of Ebola virus will be assessed during the 5-month follow-up phase. The hope is that eliminating Ebola virus from semen will decrease the risk of transmitting the virus to survivors’ sexual partners. All volunteers will be counseled to use condoms during the course of the trial.
GS-5734 has previously been tested for safety in healthy men and women in the United States, and in nonhuman primates infected experimentally with a lethal dose of Ebola virus, GS-5734 has been shown to reduce viremia and to improve survival.