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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02818582
Recruitment Status : Completed
First Posted : June 29, 2016
Results First Posted : February 15, 2022
Last Update Posted : February 15, 2022
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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 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.


Condition or disease Intervention/treatment Phase
Ebola Drug: GS-5734 Other: Placebo Comparator Phase 2

Detailed Description:

With the unprecedented size of the recent 2014-2016 West African Ebola outbreak, the scientific community is learning a great deal about the psychological and physical consequences of Ebola, Ebola viral persistence in survivors, risk of Ebola disease relapse in survivors, and the potential for survivors to transmit the virus to others. Data from PREVAIL III has demonstrated that persistence of Ebola virus in the semen of male survivors is common. In addition to Ebola virus persistence, Ebola relapse causing clinical disease has been well documented.

There are no licensed therapies for the treatment of Ebola virus disease nor for the clearance of persistent Ebola virus in survivors. A safe, effective therapy that can reduce and/or eliminate persistent Ebola virus from semen would reduce the risk of transmission and enable male survivors to resume normal sexual relations without fear of harming loved ones. The mechanism underlying Post-Ebola Syndrome is as yet unknown, but improvement in Post-Ebola signs and symptoms resulting from GS-5734 treatment would be an added benefit.

This study is a double-blind, randomized, two-phase (treatment and longer-term follow-up), two- arm trial of GS-5734 versus placebo among male Ebola survivors with persistent Ebola virus RNA in their semen. Participants are randomized 1:1 to receive either 100 mg of GS-5734 or placebo once daily by intravenous catheter for 5 days. Informed by transaminase elevations in prior Phase I studies in normal healthy subjects, a risk-mitigation strategy includes a built-in dose de-escalation. Participants will be stratified by country and on the basis of one versus two positive semen samples for Ebola virus RNA using the Cepheid GeneXpert platform assessed within 42 days prior to study enrollment. The early Data Safety and Monitoring Board (DSMB) review in August 2016 concluded there was no need for a cohort dose reduction. The protocol expanded to Guinea in October 2017, where the outbreak ended later. Currently there is an outbreak in the Democratic Republic of the Congo where the study team may evaluate conducting this study following the completion of the outbreak.

Antiviral activity, as well as safety and tolerability, will be assessed during the treatment phase. Longer-term clearance of Ebola virus will be assessed during the 5-month follow-up phase. Primary analyses for the assessment of antiviral activity in the treatment phase will focus on the assay negativity rate (ANR; percentage of genital samples that are negative for Ebola) over the first 28 days of the study, as well as clinical and laboratory adverse events. A sample is considered negative by PCR if the test result is undetectable. Primary analysis for the follow-up phase will focus on the ANR collected monthly from months 2 to 6.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GS-5734 100mg given intravenously daily for 5 days
Male Ebola survivors with persistent Ebola virus in their semen were given GS-5734 100mg intravenously daily for 5 days
Drug: GS-5734
Daily GS-5734 delivered intravenously (IV) for 5 days

Placebo Comparator: Normal saline intravenously for 5 days
Male Ebola survivors with persistent Ebola virus in their semen were given normal saline intravenously daily for 5 days
Other: Placebo Comparator
Placebo delivered intravenously (IV) for 5 days.




Primary Outcome Measures :
  1. Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase [ Time Frame: Treatment Phase (assessed at days 4, 8, 11, 16, 20, 24, & 28) ]

    Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, & 28. Average of all time points for negative values were compiled for the collected assay values.

    Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.


  2. Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase [ Time Frame: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24) ]

    Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase on weeks 8, 12, 16, 20, & 24. Average of all time points for negative values were compiled for the collected assay values.

    Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.



Secondary Outcome Measures :
  1. Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase [ Time Frame: Treatment Phase (assessed on days 4, 8, 11, 16, 20, 24, & 28) ]

    Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, & 28. Average of all time points for negative values were compiled for the collected assay values.

    Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.


  2. Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase [ Time Frame: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24) ]

    Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase - weeks 8, 12, 16, 20, & 24. Average of all time points for negative values were compiled for the collected assay values.

    Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.


  3. Mean Change From Baseline in ALT Value [ Time Frame: Treatment phase - Day 1 ]
    Mean change from baseline in alanine transaminase (ALT) value at day 1

  4. Mean Change From Baseline in ALT Value [ Time Frame: Treatment phase - Day 2 ]
    Mean change from baseline in alanine transaminase (ALT) value at day 2

  5. Mean Change From Baseline in ALT Value [ Time Frame: Treatment phase - Day 3 ]
    Mean change from baseline in alanine transaminase (ALT) value at day 3

  6. Mean Change From Baseline in ALT Value [ Time Frame: Treatment phase - Day 4 ]
    Mean change from baseline in alanine transaminase (ALT) value at day 4

  7. Mean Change From Baseline in ALT Value [ Time Frame: Treatment phase - Day 5 ]
    Mean change from baseline in alanine transaminase (ALT) value at day 5

  8. Mean Change From Baseline in ALT Value [ Time Frame: Treatment phase - Day 8 ]
    Mean change from baseline in alanine transaminase (ALT) value at day 8

  9. Mean Change From Baseline in ALT Value at Day 11 [ Time Frame: Treatment phase - Day 11 ]
    Mean change from baseline in alanine transaminase (ALT) value at day 11

  10. Mean Change From Baseline in ALT Value [ Time Frame: Treatment phase - Day 16 ]
    Mean change from baseline in alanine transaminase (ALT) value at day 16

  11. Mean Change From Baseline in ALT Value [ Time Frame: Treatment phase - Day 24 ]
    Mean change from baseline in alanine transaminase (ALT) value at at day 24

  12. Mean Change From Baseline in ALT Value [ Time Frame: Treatment phase - Day 28 ]
    Mean change from baseline in alanine transaminase (ALT) value at at day 28

  13. Mean Change From Baseline in ALT Value [ Time Frame: Follow-up phase - Week 8 ]
    Mean change from baseline in alanine transaminase (ALT) value at week 8

  14. Mean Change From Baseline in ALT Value [ Time Frame: Follow-up phase - Week 12 ]
    Mean change from baseline in alanine transaminase (ALT) Value at week 12

  15. Mean Change From Baseline in ALT Value [ Time Frame: Follow-up phase - Week 16 ]
    Mean change from baseline in alanine transaminase (ALT) value at week 16

  16. Mean Change From Baseline in ALT Value [ Time Frame: Follow-up phase - Week 20 ]
    Mean change from baseline in alanine transaminase (ALT) value at week 20

  17. Mean Change From Baseline in ALT Value [ Time Frame: Follow-up phase - Week 24 ]
    Mean change from baseline in alanine transaminase (ALT) value at week 24

  18. Mean Change From Baseline in aPTT Value [ Time Frame: Treatment phase - Day 1 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 1

  19. Mean Change From Baseline in aPTT Value [ Time Frame: Treatment phase - Day 2 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 2

  20. Mean Change From Baseline in aPTT Value [ Time Frame: Treatment phase - Day 3 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 3

  21. Mean Change From Baseline in aPTT Value [ Time Frame: Treatment phase - Day 4 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 4

  22. Mean Change From Baseline in aPTT Value [ Time Frame: Treatment phase - Day 5 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 5

  23. Mean Change From Baseline in aPTT Value [ Time Frame: Treatment phase - Day 8 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 8

  24. Mean Change From Baseline in aPTT Value [ Time Frame: Treatment phase - Day 11 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 11

  25. Mean Change From Baseline in aPTT Value [ Time Frame: Treatment phase - Day 16 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 16

  26. Mean Change From Baseline in aPTT Value [ Time Frame: Treatment phase - Day 24 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 24

  27. Mean Change From Baseline in aPTT Value [ Time Frame: Treatment phase - Day 28 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 28

  28. Mean Change From Baseline in aPTT Value [ Time Frame: Follow-up phase - Week 8 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 8

  29. Mean Change From Baseline in aPTT Value [ Time Frame: Follow-up phase - Week 12 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 12

  30. Mean Change From Baseline in aPTT Value [ Time Frame: Follow-up phase - Week 16 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 16

  31. Mean Change From Baseline in aPTT Value [ Time Frame: Follow-up phase - Week 20 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 20

  32. Mean Change From Baseline in aPTT Value [ Time Frame: Follow-up phase - Week 24 ]
    Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 24

  33. Mean Change From Baseline in AST Value [ Time Frame: Treatment phase - Day 1 ]
    Mean change from baseline in aspartate transaminase (AST) Value at day 1

  34. Mean Change From Baseline in AST Value [ Time Frame: Treatment phase - Day 2 ]
    Mean change from baseline in aspartate transaminase (AST) Value at day 2

  35. Mean Change From Baseline in AST Value [ Time Frame: Treatment phase - Day 3 ]
    Mean change from baseline in aspartate transaminase (AST) value at day 3

  36. Mean Change From Baseline in AST Value [ Time Frame: Treatment phase - Day 4 ]
    Mean change from baseline in aspartate transaminase (AST) value at day 4

  37. Mean Change From Baseline in AST Value [ Time Frame: Treatment phase - Day 5 ]
    Mean change from baseline in aspartate transaminase (AST) value at day 5

  38. Mean Change From Baseline in AST Value [ Time Frame: Treatment phase - Day 8 ]
    Mean change from baseline in aspartate transaminase (AST) value at day 8

  39. Mean Change From Baseline in AST Value [ Time Frame: Treatment phase - Day 11 ]
    Mean change from baseline in aspartate transaminase (AST) value at day 11

  40. Mean Change From Baseline in AST Value [ Time Frame: Treatment phase - Day 16 ]
    Mean change from baseline in aspartate transaminase (AST) value at day 16

  41. Mean Change From Baseline in AST Value [ Time Frame: Treatment phase - Day 24 ]
    Mean change from baseline in aspartate transaminase (AST) value at day 24

  42. Mean Change From Baseline in AST Value [ Time Frame: Treatment phase - Day 28 ]
    Mean change from baseline in aspartate transaminase (AST) value at day 28

  43. Mean Change From Baseline in AST Value [ Time Frame: Follow-up phase - Week 8 ]
    Mean change from baseline in aspartate transaminase (AST) value at week 8

  44. Mean Change From Baseline in AST Value [ Time Frame: Follow-up phase - Week 12 ]
    Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 12

  45. Mean Change From Baseline in AST Value [ Time Frame: Follow-up phase - Week 16 ]
    Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 16

  46. Mean Change From Baseline in AST Value [ Time Frame: Follow-up phase - Week 20 ]
    Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 20

  47. Mean Change From Baseline in AST Value [ Time Frame: Follow-up phase - Week 24 ]
    Mean change from baseline in aspartate transaminase (AST) value at week 24

  48. Mean Change From Baseline in INR Value [ Time Frame: Treatment phase - Day 1 ]
    Mean change from baseline in international normalized ratio (INR) value at day 1

  49. Mean Change From Baseline in INR Value [ Time Frame: Treatment phase - Day 2 ]
    Mean change from baseline in international normalized ratio (INR) value at day 2

  50. Mean Change From Baseline in INR Value [ Time Frame: Treatment phase - Day 3 ]
    Mean change from baseline in international normalized ratio (INR) value at day 3

  51. Mean Change From Baseline in INR Value [ Time Frame: Treatment phase - Day 4 ]
    Mean change from baseline in international normalized ratio (INR) value at day 4

  52. Mean Change From Baseline in INR Value [ Time Frame: Treatment phase - Day 5 ]
    Mean change from baseline in international normalized ratio (INR) value at day 5

  53. Mean Change From Baseline in INR Value [ Time Frame: Treatment phase - Day 8 ]
    Mean change from baseline in international normalized ratio (INR) value at day 8

  54. Mean Change From Baseline in INR Value [ Time Frame: Treatment phase - Day 11 ]
    Mean change from baseline in international normalized ratio (INR) value at day 11

  55. Mean Change From Baseline in INR Value [ Time Frame: Treatment phase - Day 16 ]
    Mean change from baseline in international normalized ratio (INR) value at day 16

  56. Mean Change From Baseline in INR Value [ Time Frame: Treatment phase - Day 24 ]
    Mean change from baseline in international normalized ratio (INR) value at day 24

  57. Mean Change From Baseline in INR Value [ Time Frame: Treatment phase - Day 28 ]
    Mean change from baseline in international normalized ratio (INR) value at day 28

  58. Mean Change From Baseline in INR Value [ Time Frame: Follow-up phase - Week 8 ]
    Mean change from baseline in international normalized ratio (INR) value at week 8

  59. Mean Change From Baseline in INR Value [ Time Frame: Follow-up phase - Week 12 ]
    Mean change from baseline in international normalized ratio (INR) value at week 12

  60. Mean Change From Baseline in INR Value [ Time Frame: Follow-up phase - Week 16 ]
    Mean change from baseline in international normalized ratio (INR) value at week 16

  61. Mean Change From Baseline in INR Value [ Time Frame: Follow-up phase - Week 20 ]
    Mean change from baseline in international normalized ratio (INR) value at week 20

  62. Mean Change From Baseline in INR Value [ Time Frame: Follow-up phase - Week 24 ]
    Mean change from baseline in international normalized ratio (INR) value at week 24

  63. Mean Change From Baseline in PT Value [ Time Frame: Treatment phase - Day 1 ]
    Mean change from baseline in prothrombin time (PT) value at day 1

  64. Mean Change From Baseline in PT Value [ Time Frame: Treatment phase - Day 2 ]
    Mean change from baseline in prothrombin time (PT) value at day 2

  65. Mean Change From Baseline in PT Value [ Time Frame: Treatment phase - Day 3 ]
    Mean change from baseline in prothrombin time (PT) value at day 3

  66. Mean Change From Baseline in PT Value [ Time Frame: Treatment phase - Day 4 ]
    Mean change from baseline in prothrombin time (PT) value at day 4

  67. Mean Change From Baseline in PT Value [ Time Frame: Treatment phase - Day 5 ]
    Mean change from baseline in prothrombin time (PT) value at day 5

  68. Mean Change From Baseline in PT Value [ Time Frame: Treatment phase - Day 8 ]
    Mean change from baseline in prothrombin time (PT) value at day 8

  69. Mean Change From Baseline in PT Value [ Time Frame: Treatment phase - Day 11 ]
    Mean change from baseline in prothrombin time (PT) value at day 11

  70. Mean Change From Baseline in PT Value [ Time Frame: Treatment phase - Day 16 ]
    Mean change from baseline in prothrombin time (PT) value at day 16

  71. Mean Change From Baseline in PT Value [ Time Frame: Treatment phase - Day 24 ]
    Mean change from baseline in prothrombin time (PT) value at day 24

  72. Mean Change From Baseline in PT Value [ Time Frame: Treatment phase - Day 28 ]
    Mean change from baseline in prothrombin time (PT) value at day 28

  73. Mean Change From Baseline in PT Value [ Time Frame: Follow-up phase - Week 8 ]
    Mean change from baseline in prothrombin time (PT) value at week 8

  74. Mean Change From Baseline in PT Value [ Time Frame: Follow-up phase - Week 12 ]
    Mean change from baseline in prothrombin time (PT) value at week 12

  75. Mean Change From Baseline in PT Value [ Time Frame: Follow-up phase - Week 16 ]
    Mean change from baseline in prothrombin time (PT) value at week 16

  76. Mean Change From Baseline in PT Value [ Time Frame: Follow-up phase - Week 20 ]
    Mean change from baseline in prothrombin time (PT) value at week 20

  77. Mean Change From Baseline in PT Value [ Time Frame: Follow-up phase - Week 24 ]
    Mean change from baseline in prothrombin time (PT) value at week 24

  78. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Treatment phase - Day 1 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at day 1.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (AE) [DAIDS AE grading table] version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  79. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Treatment phase - Day 2 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 2.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  80. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Treatment phase - Day 3 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 3.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  81. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Treatment phase - Day 4 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 4.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  82. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Treatment phase - Day 5 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 5.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  83. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Treatment phase - Day 8 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  84. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Treatment phase - Day 11 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 11.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  85. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Treatment phase - Day 16 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  86. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Treatment phase - Day 24 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  87. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Treatment phase - Day 28 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 28.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  88. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Follow-up phase - Week 8 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  89. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Follow-up phase - Week 12 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 12.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  90. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Follow-up phase - Week 16 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  91. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Follow-up phase - Week 20 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 20.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  92. Number of Participants With Increase in Grade From Baseline for ALT Value [ Time Frame: Follow-up phase - Week 24 ]

    Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at week 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  93. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Treatment phase - Day 1 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 1.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  94. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Treatment phase - Day 2 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 2.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  95. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Treatment phase - Day 3 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 3.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  96. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Treatment phase - Day 4 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 4.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  97. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Treatment phase - Day 5 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 5.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  98. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Treatment phase - Day 8 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  99. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Treatment phase - Day 11 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 11.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  100. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Treatment phase - Day 16 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  101. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Treatment phase - Day 24 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  102. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Treatment phase - Day 28 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 28.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  103. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Follow-up phase - Week 8 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  104. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Follow-up phase - Week 12 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 12.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  105. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Follow-up phase - Week 16 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  106. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Follow-up phase - Week 20 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 20.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  107. Number of Participants With Increase in Grade From Baseline for aPTT Value [ Time Frame: Follow-up phase - Week 24 ]

    Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  108. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Treatment phase - Day 1 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 1.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  109. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Treatment phase - Day 2 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 2.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  110. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Treatment phase - Day 3 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 3.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  111. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Treatment phase - Day 4 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 4.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  112. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Treatment phase - Day 5 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 5.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  113. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Treatment phase - Day 8 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  114. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Treatment phase - Day 11 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 11.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  115. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Treatment phase - Day 16 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  116. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Treatment phase - Day 24 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  117. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Treatment phase - Day 28 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 28.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  118. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Follow-up phase - Week 8 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  119. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Follow-up phase - Week 12 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 12.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  120. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Follow-up phase - Week 16 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  121. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Follow-up phase - Week 20 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at week 20.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  122. Number of Participants With Increase in Grade From Baseline for AST Value [ Time Frame: Follow-up phase - Week 24 ]

    Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)


  123. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Treatment phase - Day 1 ]

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 1.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  124. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Treatment phase - Day 2 ]

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 2.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  125. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Treatment phase - Day 3 ]

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 3.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  126. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Treatment phase - Day 4 ]

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 4.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  127. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Treatment phase - Day 5 ]

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 5.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  128. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Treatment phase - Day 8 ]

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  129. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Treatment phase - Day 11 ]

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 11.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  130. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Treatment phase - Day 16 ]

    Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  131. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Treatment phase - Day 24 ]

    Number of participants increase in grade from baseline in prothrombin time (PT) value at day 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  132. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Treatment phase - Day 28 ]

    Number of participants increase in grade from baseline in prothrombin time (PT) value at day 28.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  133. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Follow-up phase - Week 8 ]

    Number of participants increase in grade from baseline in prothrombin time (PT) value at week 8.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  134. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Follow-up phase - Week 12 ]

    Number of participants increase in grade from baseline in prothrombin time (PT) value at week 12.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  135. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Follow-up phase - Week 16 ]

    Number of participants increase in grade from baseline in prothrombin time (PT) value at week 16.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  136. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Follow-up phase - Week 20 ]

    Number of participants increase in grade from baseline in prothrombin time (PT) value at week 20.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  137. Number of Participants With Increase in Grade From Baseline for PT Value [ Time Frame: Follow-up phase - Week 24 ]

    Number of participants increase in grade from baseline in prothrombin time (PT) value at week 24.

    Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).

    PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)


  138. Participants With Grade 1 ALT Level [ Time Frame: Treatment phase - Day 1 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 1

  139. Participants With Grade 1 ALT Level [ Time Frame: Treatment phase - Day 2 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 2

  140. Participants With Grade 1 ALT Level [ Time Frame: Treatment phase - Day 3 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 3

  141. Participants With Grade 1 ALT Level [ Time Frame: Treatment phase - Day 4 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 4

  142. Participants With Grade 1 ALT Level [ Time Frame: Treatment phase - Day 5 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 5

  143. Participants With Grade 1 ALT Level [ Time Frame: Treatment phase - Day 8 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 8

  144. Participants With Grade 1 ALT Level [ Time Frame: Treatment phase - Day 11 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 11

  145. Participants With Grade 1 ALT Level [ Time Frame: Treatment phase - Day 16 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 16

  146. Participants With Grade 1 ALT Level [ Time Frame: Treatment phase - Day 24 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 24

  147. Participants With Grade 1 ALT Level [ Time Frame: Treatment phase - Day 28 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 28

  148. Participants With Grade 1 ALT Level [ Time Frame: Follow-up phase - Week 8 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 8

  149. Participants With Grade 1 ALT Level [ Time Frame: Follow-up phase - Week 12 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 12

  150. Participants With Grade 1 ALT Level [ Time Frame: Follow-up phase - Week 16 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 16

  151. Participants With Grade 1 ALT Level [ Time Frame: Follow-up phase - Week 20 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 20

  152. Participants With Grade 1 ALT Level [ Time Frame: Follow-up phase - Week 24 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 24

  153. Participants With Grade 1 AST Level [ Time Frame: Treatment phase - Day 1 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 1

  154. Participants With Grade 1 AST Level [ Time Frame: Treatment phase - Day 2 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 2

  155. Participants With Grade 1 AST Level [ Time Frame: Treatment phase - Day 3 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 3

  156. Participants With Grade 1 AST Level [ Time Frame: Treatment phase - Day 4 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 4

  157. Participants With Grade 1 AST Level [ Time Frame: Treatment phase - Day 5 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 5

  158. Participants With Grade 1 AST Level [ Time Frame: Treatment phase - Day 8 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 8

  159. Participants With Grade 1 AST Level [ Time Frame: Treatment phase - Day 11 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 11

  160. Participants With Grade 1 AST Level [ Time Frame: Treatment phase - Day 16 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 16

  161. Participants With Grade 1 AST Level [ Time Frame: Treatment phase - Day 24 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 24

  162. Participants With Grade 1 AST Level [ Time Frame: Treatment phase - Day 28 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 28

  163. Participants With Grade 1 AST Level [ Time Frame: Follow-up phase - Week 8 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 8

  164. Participants With Grade 1 AST Level [ Time Frame: Follow-up phase - Week 12 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 12

  165. Participants With Grade 1 AST Level [ Time Frame: Follow-up phase - Week 16 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 16

  166. Participants With Grade 1 AST Level [ Time Frame: Follow-up phase - Week 24 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 24

  167. Participants With Grade 1 AST Level [ Time Frame: Follow-up phase - Week 28 ]
    Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 28

  168. Participants With Grade 2 ALT Level [ Time Frame: Treatment phase - Day 1 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 1

  169. Participants With Grade 2 ALT Level [ Time Frame: Treatment phase - Day 2 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 2

  170. Participants With Grade 2 ALT Level [ Time Frame: Treatment phase - Day 3 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 3

  171. Participants With Grade 2 ALT Level [ Time Frame: Treatment phase - Day 4 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 4

  172. Participants With Grade 2 ALT Level [ Time Frame: Treatment phase - Day 5 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 5

  173. Participants With Grade 2 ALT Level [ Time Frame: Treatment phase - Day 8 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 8

  174. Participants With Grade 2 ALT Level [ Time Frame: Treatment phase - Day 11 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 11

  175. Participants With Grade 2 ALT Level [ Time Frame: Treatment phase - Day 16 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 16

  176. Participants With Grade 2 ALT Level [ Time Frame: Treatment phase - Day 24 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 24

  177. Participants With Grade 2 ALT Level [ Time Frame: Treatment phase - Day 28 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 28

  178. Participants With Grade 2 ALT Level [ Time Frame: Follow-up phase - Week 8 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 8

  179. Participants With Grade 2 ALT Level [ Time Frame: Follow-up phase - Week 12 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 12

  180. Participants With Grade 2 ALT Level [ Time Frame: Follow-up phase - Week 16 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 16

  181. Participants With Grade 2 ALT Level [ Time Frame: Follow-up phase - Week 20 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 20

  182. Participants With Grade 2 ALT Level [ Time Frame: Follow-up phase - Week 24 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 24

  183. Participants With Grade 2 AST Level [ Time Frame: Treatment phase - Day 1 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 1

  184. Participants With Grade 2 AST Level [ Time Frame: Treatment phase - Day 2 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 2

  185. Participants With Grade 2 AST Level [ Time Frame: Treatment phase - Day 3 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 3

  186. Participants With Grade 2 AST Level [ Time Frame: Treatment phase - Day 4 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 4

  187. Participants With Grade 2 AST Level [ Time Frame: Treatment phase - Day 5 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 5

  188. Participants With Grade 2 AST Level [ Time Frame: Treatment phase - Day 8 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 8

  189. Participants With Grade 2 AST Level [ Time Frame: Treatment phase - Day 11 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 11

  190. Participants With Grade 2 AST Level [ Time Frame: Treatment phase - Day 16 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 16

  191. Participants With Grade 2 AST Level [ Time Frame: Treatment phase - Day 24 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 24

  192. Participants With Grade 2 AST Level [ Time Frame: Treatment phase - Day 28 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 28

  193. Participants With Grade 2 AST Level [ Time Frame: Follow-up phase - Week 8 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 8

  194. Participants With Grade 2 AST Level [ Time Frame: Follow-up phase - Week 12 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 12

  195. Participants With Grade 2 AST Level [ Time Frame: Follow-up phase - Week 16 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 16

  196. Participants With Grade 2 AST Level [ Time Frame: Follow-up phase - Week 24 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 24

  197. Participants With Grade 2 AST Level [ Time Frame: Follow-up phase - Week 28 ]
    Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 28

  198. Participants With Grade 3 ALT Level [ Time Frame: Treatment phase - Day 1 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 1

  199. Participants With Grade 3 ALT Level [ Time Frame: Treatment phase - Day 2 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 2

  200. Participants With Grade 3 ALT Level [ Time Frame: Treatment phase - Day 3 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 3

  201. Participants With Grade 3 ALT Level [ Time Frame: Treatment phase - Day 4 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 4

  202. Participants With Grade 3 ALT Level [ Time Frame: Treatment phase - Day 5 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 5

  203. Participants With Grade 3 ALT Level [ Time Frame: Treatment phase - Day 8 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 8

  204. Participants With Grade 3 ALT Level [ Time Frame: Treatment phase - Day 11 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 11

  205. Participants With Grade 3 ALT Level [ Time Frame: Treatment phase - Day 16 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 16

  206. Participants With Grade 3 ALT Level [ Time Frame: Treatment phase - Day 24 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 24

  207. Participants With Grade 3 ALT Level [ Time Frame: Treatment phase - Day 28 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 28

  208. Participants With Grade 3 ALT Level [ Time Frame: Follow-up phase - Week 8 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 8

  209. Participants With Grade 3 ALT Level [ Time Frame: Follow-up phase - Week 12 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 12

  210. Participants With Grade 3 ALT Level [ Time Frame: Follow-up phase - Week 16 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 16

  211. Participants With Grade 3 ALT Level [ Time Frame: Follow-up phase - Week 20 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 20

  212. Participants With Grade 3 ALT Level [ Time Frame: Follow-up phase - Week 24 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 24

  213. Participants With Grade 3 AST Level [ Time Frame: Treatment phase - Day 1 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 1

  214. Participants With Grade 3 AST Level [ Time Frame: Treatment phase - Day 2 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 2

  215. Participants With Grade 3 AST Level [ Time Frame: Treatment phase - Day 3 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 3

  216. Participants With Grade 3 AST Level [ Time Frame: Treatment phase - Day 4 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 4

  217. Participants With Grade 3 AST Level [ Time Frame: Treatment phase - Day 5 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 5

  218. Participants With Grade 3 AST Level [ Time Frame: Treatment phase - Day 8 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 8

  219. Participants With Grade 3 AST Level [ Time Frame: Treatment phase - Day 11 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 11

  220. Participants With Grade 3 AST Level [ Time Frame: Treatment phase - Day 16 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 16

  221. Participants With Grade 3 AST Level [ Time Frame: Treatment phase - Day 24 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 24

  222. Participants With Grade 3 AST Level [ Time Frame: Treatment phase - Day 28 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 28

  223. Participants With Grade 3 AST Level [ Time Frame: Follow-up phase - Week 8 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 8

  224. Participants With Grade 3 AST Level [ Time Frame: Follow-up phase - Week 12 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 12

  225. Participants With Grade 3 AST Level [ Time Frame: Follow-up phase - Week 16 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 16

  226. Participants With Grade 3 AST Level [ Time Frame: Follow-up phase - Week 24 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 24

  227. Participants With Grade 3 AST Level [ Time Frame: Follow-up phase - Week 28 ]
    Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 28

  228. Participants With Grade 4 ALT Level [ Time Frame: Treatment phase - Day 1 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 1

  229. Participants With Grade 4 ALT Level [ Time Frame: Treatment phase - Day 2 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 2

  230. Participants With Grade 4 ALT Level [ Time Frame: Treatment phase - Day 3 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 3

  231. Participants With Grade 4 ALT Level [ Time Frame: Treatment phase - Day 4 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 4

  232. Participants With Grade 4 ALT Level [ Time Frame: Treatment phase - Day 5 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 5

  233. Participants With Grade 4 ALT Level [ Time Frame: Treatment phase - Day 8 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 8

  234. Participants With Grade 4 ALT Level [ Time Frame: Treatment phase - Day 11 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 11

  235. Participants With Grade 4 ALT Level [ Time Frame: Treatment phase - Day 16 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 16

  236. Participants With Grade 4 ALT Level [ Time Frame: Treatment phase - Day 24 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 24

  237. Participants With Grade 4 ALT Level [ Time Frame: Treatment phase - Day 28 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 28

  238. Participants With Grade 4 ALT Level [ Time Frame: Follow-up phase - Week 8 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 8

  239. Participants With Grade 4 ALT Level [ Time Frame: Follow-up phase - Week 12 ]
    Participants with grade 4 (> 10 x ULN) alanine aminotransferase (ALT) level at week 12

  240. Participants With Grade 4 ALT Level [ Time Frame: Follow-up phase - Week 16 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 16

  241. Participants With Grade 4 ALT Level [ Time Frame: Follow-up phase - Week 20 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 20

  242. Participants With Grade 4 ALT Level [ Time Frame: Follow-up phase - Week 24 ]
    Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 24

  243. Participants With Grade 4 AST Level [ Time Frame: Treatment phase - Day 1 ]
    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 1

  244. Participants With Grade 4 AST Level [ Time Frame: Treatment phase - Day 2 ]
    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 2

  245. Participants With Grade 4 AST Level [ Time Frame: Treatment phase - Day 3 ]
    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 3

  246. Participants With Grade 4 AST Level [ Time Frame: Treatment phase - Day 4 ]
    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 4

  247. Participants With Grade 4 AST Level [ Time Frame: Treatment phase - Day 5 ]
    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 5

  248. Participants With Grade 4 AST Level [ Time Frame: Treatment phase - Day 8 ]
    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 8

  249. Participants With Grade 4 AST Level [ Time Frame: Treatment phase - Day 11 ]
    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 11

  250. Participants With Grade 4 AST Level [ Time Frame: Treatment phase - Day 16 ]
    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 16

  251. Participants With Grade 4 AST Level [ Time Frame: Treatment phase - Day 24 ]
    Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 24

  252. Participants With Grade 4 AST Level [ Time Frame: Treatment phase - Day 28 ]
    Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 28

  253. Participants With Grade 4 AST Level [ Time Frame: Follow-up phase - Week 8 ]
    Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 8

  254. Participants With Grade 4 AST Level [ Time Frame: Follow-up phase - Week 12 ]
    Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 12

  255. Participants With Grade 4 AST Level [ Time Frame: Follow-up phase - Week 16 ]
    Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 16

  256. Participants With Grade 4 AST Level [ Time Frame: Follow-up phase - Week 24 ]
    Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 24

  257. Participants With Grade 4 AST Level [ Time Frame: Follow-up phase - Week 28 ]
    Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 28



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818582


Locations
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Guinea
Partnership of Clinical Research in Guinea (PREGUI) / Centre National de Formation et de Recherche en Santé Rurale de Mafèrinyah
Forécariah, Maferinyah, Guinea
Liberia
JFK Hospital Partnership for Research for Vaccines and Infectious Diseases in Liberia (PREVAIL)
Monrovia, Liberia, FWA00021658
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Gilead Sciences
Investigators
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Principal Investigator: Elizabeth S Higgs, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  Study Documents (Full-Text)

Documents provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02818582    
Other Study ID Numbers: 999916137
16-I-N137
First Posted: June 29, 2016    Key Record Dates
Results First Posted: February 15, 2022
Last Update Posted: February 15, 2022
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Liberia
Guinea
Additional relevant MeSH terms:
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Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Virus Diseases
Infections
Filoviridae Infections
Mononegavirales Infections
Remdesivir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents