Trial Outcomes & Findings for Rifaximin for Chronic Immune Activation in People With HIV (NCT NCT01866826)
NCT ID: NCT01866826
Last Updated: 2020-02-26
Results Overview
One sample Wilcoxon statistic was applied to evaluate the difference on treatment phases between the placebo and Rifaximin.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2
Results posted on
2020-02-26
Participant Flow
Upon completion of a 4 week course of rifaximin or placebo subjects will undergo a 4-6 week washout period and cross over treatment assignments to complete a 4 week course of either rifaximin or placebo.
Participant milestones
| Measure |
Rifaximin, Then Placebo
Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.
Subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily) for 4 weeks, followed by a 4-6 week washout period, and then will receive three capsules of placebo by mouth twice daily for 4 weeks.
|
Placebo, Then Rifaximin
HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design. Placebo
Subject will receive three capsules of placebo by mouth twice daily for 4 weeks, followed by a 4-6 week washout period, and then will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily) for 4 weeks.
|
|---|---|---|
|
Phase I -Initial Randomization - 4 Weeks
STARTED
|
23
|
23
|
|
Phase I -Initial Randomization - 4 Weeks
COMPLETED
|
22
|
23
|
|
Phase I -Initial Randomization - 4 Weeks
NOT COMPLETED
|
1
|
0
|
|
Wash-Out Period - 4 -6 Weeks
STARTED
|
22
|
23
|
|
Wash-Out Period - 4 -6 Weeks
COMPLETED
|
22
|
20
|
|
Wash-Out Period - 4 -6 Weeks
NOT COMPLETED
|
0
|
3
|
|
Second Intervention - 4 Weeks
STARTED
|
22
|
20
|
|
Second Intervention - 4 Weeks
COMPLETED
|
22
|
20
|
|
Second Intervention - 4 Weeks
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Rifaximin, Then Placebo
Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.
Subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily) for 4 weeks, followed by a 4-6 week washout period, and then will receive three capsules of placebo by mouth twice daily for 4 weeks.
|
Placebo, Then Rifaximin
HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design. Placebo
Subject will receive three capsules of placebo by mouth twice daily for 4 weeks, followed by a 4-6 week washout period, and then will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily) for 4 weeks.
|
|---|---|---|
|
Phase I -Initial Randomization - 4 Weeks
Post Enrollment Withdrawal
|
1
|
0
|
|
Wash-Out Period - 4 -6 Weeks
Withdrawal by Subject
|
0
|
2
|
|
Wash-Out Period - 4 -6 Weeks
Post Enrollment Withdrawal
|
0
|
1
|
Baseline Characteristics
Rifaximin for Chronic Immune Activation in People With HIV
Baseline characteristics by cohort
| Measure |
All Participants
n=46 Participants
All human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.609 years
STANDARD_DEVIATION 9.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2Population: 46 randomized participants, 37 had evaluable results. Number of participants analyzed differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
One sample Wilcoxon statistic was applied to evaluate the difference on treatment phases between the placebo and Rifaximin.
Outcome measures
| Measure |
Rifaximin
n=37 Participants
Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.
Rifaximim: subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily).
|
Placebo
n=37 Participants
HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design.
Placebo: Subject will receive three capsules of placebo by mouth twice daily.
|
|---|---|---|
|
Changes in Soluble Cluster of Differentiation 14 (sCD14) Levels Between the Placebo and Rifaximin Phases of the Study
|
0.0067 mcg/mL
Interval -0.0097 to 0.22
|
0.0035 mcg/mL
Interval -0.195 to 0.154
|
SECONDARY outcome
Timeframe: Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2Population: Number of participants analyzed differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
HIV-1-RNA levels were assessed by using the single copy assay or the traditional HIV Branched Deoxyribonucleic Acid bDNA assay to determine elevations in HIV-1 RNA \>50 copies/ml plasma at the end of the Rifaximin or placebo phase. Differences were tested by using both the Wilcoxon and the t-test.
Outcome measures
| Measure |
Rifaximin
n=43 Participants
Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.
Rifaximim: subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily).
|
Placebo
n=43 Participants
HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design.
Placebo: Subject will receive three capsules of placebo by mouth twice daily.
|
|---|---|---|
|
Number of Participants With Viral (HIV-1)-Ribonucleic Acid (RNA) Elevated by Greater Than 50 Copies/ml Plasma at the End of the Rifaximin or Placebo Phase
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2Population: 46 randomized participants, 37 had evaluable results. Number of participants analyzed differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
Changes in soluble marker of inflammation Interleukin 6 (IL6) between the placebo and rifaximin phases of the study. Differences will be tested by using both the Wilcoxon and the t-test.
Outcome measures
| Measure |
Rifaximin
n=37 Participants
Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.
Rifaximim: subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily).
|
Placebo
n=37 Participants
HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design.
Placebo: Subject will receive three capsules of placebo by mouth twice daily.
|
|---|---|---|
|
Changes in Soluble Markers of Inflammation Between the Placebo and Rifaximin Phases of the Study
|
7.94 picograms/milliliter
Standard Deviation 3.89
|
8.10 picograms/milliliter
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2Population: 46 randomized participants, 37 had evaluable results. Number of participants analyzed differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
Changes in cellular markers of immune activation (IA) is defined as changes in the percentage of cluster of differentiation 4 (CD4) + or cluster of differentiation 8 (CD8)+ T cells that express human leukocyte antigen - antigen D Related (HLA-DR) and cluster of differentiation 38 (CD38). Differences will be tested by using both the Wilcoxon and the t-test.
Outcome measures
| Measure |
Rifaximin
n=37 Participants
Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.
Rifaximim: subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily).
|
Placebo
n=37 Participants
HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design.
Placebo: Subject will receive three capsules of placebo by mouth twice daily.
|
|---|---|---|
|
Changes in Cellular Markers of Immune Activation Between the Placebo and Rifaximin Phases of the Study
|
10.00 percentage of lymphocytes
Standard Deviation 5.34
|
9.92 percentage of lymphocytes
Standard Deviation 4.97
|
SECONDARY outcome
Timeframe: From baseline until up to approximately 14 weeksPopulation: Number of participants analyzed differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
The number of participants with serious and non-serious adverse events that were possibly related to Rifaximin or Placebo as assessed by the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Rifaximin
n=43 Participants
Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.
Rifaximim: subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily).
|
Placebo
n=45 Participants
HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design.
Placebo: Subject will receive three capsules of placebo by mouth twice daily.
|
|---|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
|
12 Participants
|
11 Participants
|
Adverse Events
Rifaximin
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rifaximin
n=43 participants at risk
Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.
Rifaximim: subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily).
|
Placebo
n=45 participants at risk
HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design.
Placebo: Subject will receive three capsules of placebo by mouth twice daily.
|
|---|---|---|
|
Gastrointestinal disorders
Adenocarcinoma gastric
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
Other adverse events
| Measure |
Rifaximin
n=43 participants at risk
Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design.
Rifaximim: subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily).
|
Placebo
n=45 participants at risk
HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design.
Placebo: Subject will receive three capsules of placebo by mouth twice daily.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43 • Number of events 4 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Investigations
Alanine aminotransferase increased
|
4.7%
2/43 • Number of events 2 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
4.4%
2/45 • Number of events 2 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Investigations
Amylase increased
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Anal examination abnormal
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Anal fissure
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Anal spasm
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Investigations
Aspartate aminotransferase increased
|
4.7%
2/43 • Number of events 2 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 2 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Reproductive system and breast disorders
Bacterial vaginosis
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Investigations
Blood bicarbonate abnormal
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
6.7%
3/45 • Number of events 4 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Investigations
Blood creatinine increased
|
4.7%
2/43 • Number of events 2 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
4.4%
2/45 • Number of events 3 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
General disorders
Chills
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Defecation urgency
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
6.7%
3/45 • Number of events 3 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Nervous system disorders
Dizziness
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Renal and urinary disorders
Dysuria
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Hematemesis
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Renal and urinary disorders
Hematuria
|
4.7%
2/43 • Number of events 2 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.7%
2/43 • Number of events 2 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Nervous system disorders
Headache
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
4.4%
2/45 • Number of events 2 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Eye disorders
Hordeolum
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Vascular disorders
Hot flush
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.3%
4/43 • Number of events 4 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
6.7%
3/45 • Number of events 4 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza like illness
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
General disorders
Lethargy
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Investigations
Lipase increased
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Nausea
|
4.7%
2/43 • Number of events 3 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Oral disorder
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 2 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Infections and infestations
Paronychia
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Renal and urinary disorders
Proteinuria
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
General disorders
Pyrexia
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Stomatitis
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Reproductive system and breast disorders
Testicular disorder
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Infections and infestations
Tooth infection
|
2.3%
1/43 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/43 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
2.2%
1/45 • Number of events 1 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
2/43 • Number of events 2 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
0.00%
0/45 • From baseline until up to approximately 14 weeks.
The Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, 2004, (Clarification August, 2009) was utilized for grading adverse events. Number of participants affected differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place