GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen
Condition: Ebola
MeSH terms: Hemorrhagic Fever, Ebola
Intervention: GS-5734; Placebo Comparator
Intervention description: Daily GS-5734 delivered intravenously (IV) for 5 days; Placebo delivered intravenously (IV) for 5 days.
Intervention MeSH terms: Remdesivir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: Male
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Liberia; Guinea

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 the infusions, participants will have 5 visits in the first month, then 1 per month for
      5 more months. These include giving a blood and semen sample.

      Blood tests are performed before and after each infusion and the last visit (5 month visit)
      will also include an eye exam.

      When the study is over, if the study drug works and is safe, participants who got the placebo
      can get the study drug.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Individuals must meet all of the following criteria to be eligible for study participation:

          -  Men more than or equal to 18 years of age.

          -  One of two semen samples with Ebola virus RNA detection (defined as a positive PCR for
             NP or GP using the GeneXpert assay within 42 days prior to randomization).

          -  Willingness to be available for study evaluations for 6 months.

          -  Willingness to allow storage of biological samples.

          -  Willingness to be followed by a Participant Tracker.

          -  Willingness to refrain from alcohol consumption for study days -7 to 14.

          -  Willingness to comply with MOH & CDC guidance on using a condom for sexual activity
             and at least through week 24 of the study.

        EXCLUSION CRITERIA:

        Individuals meeting any of the following criteria will be excluded from study
        participation:

          -  Estimated glomerular filtration rate less than 60 mL/min/1.73m^2

          -  History of significant renal disease

          -  History of significant liver disease

          -  Evidence of liver disease on physical exam such as ascites

          -  Aspartate transaminase (AST) or alanine transaminase (ALT), greater than the upper
             limit of normal, a prothrombin time 1.1 times greater than the upper limits of normal,
             normal, or a total bilirubin > 1.5 times the upper limits of normal(per Division of
             Acquired Immunodeficiency Syndrome (DAIDS) toxicity tables version 2.0 Nov. 2014).

          -  Presence of Grade 2 or higher abnormalities for: low hemoglobin, low white blood count
             (WBC), low platelets, or low or high potassium (per DAIDS toxicity tables version 2.0
             Nov. 2014).

          -  Presence of greater than Grade 2 abnormalities for low or high sodium (per DAIDS
             toxicity tables version 2.0 Nov. 2014).

          -  Any condition that, in the opinion of the investigator, would compromise the safety of
             the study subject or staff, or would prevent proper conduct of the study.