Trial Outcomes & Findings for Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV (NCT NCT01852942)
NCT ID: NCT01852942
Last Updated: 2020-12-11
Results Overview
The Impact of Losartan Treatment on Lymphoid Tissue (LT) Fibrosis will be determined by measuring the amount of collagen deposition in LT using immunohistochemistry (IHC) and quantitative image analysis (QIA). LT will be obtained at baseline, month 12 and month 30.
COMPLETED
PHASE2
52 participants
30 months
2020-12-11
Participant Flow
Participant milestones
| Measure |
Losartan
Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months.
|
Sugar Pill
Placebo: one tablet by mouth daily
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Losartan
Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months.
|
Sugar Pill
Placebo: one tablet by mouth daily
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
Baseline characteristics by cohort
| Measure |
Losartan
n=25 Participants
Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months.
|
Sugar Pill
n=27 Participants
Placebo: one tablet by mouth daily
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 11 • n=5 Participants
|
50 years
STANDARD_DEVIATION 11 • n=7 Participants
|
50 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 monthsPopulation: Some participant data was left out of this analysis due to sample quality.
The Impact of Losartan Treatment on Lymphoid Tissue (LT) Fibrosis will be determined by measuring the amount of collagen deposition in LT using immunohistochemistry (IHC) and quantitative image analysis (QIA). LT will be obtained at baseline, month 12 and month 30.
Outcome measures
| Measure |
Losartan
n=12 Participants
Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months.
|
Sugar Pill
n=13 Participants
Placebo: one tablet by mouth daily
|
|---|---|---|
|
Collagen Deposition in LT
12 months
|
34.866 percent area
Standard Deviation 9.3914
|
31.02 percent area
Standard Deviation 5.6795
|
|
Collagen Deposition in LT
30 months
|
30.8925 percent area
Standard Deviation 9.4894
|
29.4492 percent area
Standard Deviation 6.2988
|
PRIMARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan Treatment on Lymphoid Tissue (LT) Fibrosis will be determined by measuring the Integrity of the fibroblastic reticular cell network (FRCn) using immunohistochemistry (IHC) and quantitative image analysis (QIA). LT will be obtained at baseline, month 12 and month 30.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
Impact of losartan on immune reconstitution and function will be determined by frequency of CD4+ T cells in LT using IHC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
Impact of losartan on immune reconstitution and function will be determined by frequency of TUNEL+CD3+CD8+ T cells in LT using IHC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
Impact of losartan on immune reconstitution and function will be determined by frequency of cells expressing TGF-beta and lymphotoxin-beta in LT using IHC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
Impact of losartan on immune reconstitution and function will be determine by serum concentrations of IL-7 measured with ELISA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
Impact of losartan on immune reconstitution and function will be determine by serum concentrations of TGF-beta measured with ELISA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
Impact of losartan on immune reconstitution and function will be determine by measuring the immune response to HPV vaccination using flow cytometry to identify cells stimulated by specific HPV peptides.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the frequency of activated T-cell populations (specifically CD3+CD4+CD38+, CD3+,CD8+CD38+,CD4+Ki67+ and CD8+Ki67+ T cells) in LT using immunofluorescence staining
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated T cells in peripheral blood mononuclear cells (PBMCs) using flow cytometry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated macrophages in peripheral blood mononuclear cells (PBMCs) using flow cytometry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated dendritic cells in peripheral blood mononuclear cells (PBMCs) using flow cytometry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated T cells in lymphoid tissues (LT) using flow cytometry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated macrophages in lymphoid tissues (LT) using flow cytometry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated dendritic cells in lymphoid tissues (LT) using flow cytometry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-17 in PBMCs using cytokine staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IFNg in PBMCs using cytokine staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-2 in PBMCs using cytokine staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine TNF in PBMCs using cytokine staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-10 in PBMCs using cytokine staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine GM-CSF in PBMCs using cytokine staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-17 in lymphoid tissue (LT) using cytokine staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IFNg in lymphoid tissue (LT) using cytokine staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-2 in lymphoid tissue (LT) using cytokine staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine TNF in lymphoid tissue (LT) using cytokine staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-10 in lymphoid tissue (LT) using cytokine staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine GM-CSF in lymphoid tissue (LT) using cytokine staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of LPS by ELISA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of sCD14 by limulus assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of I-FABP using ELISA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of IL-1b using ELISA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of IL-1RA using ELISA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of IL-6 using ELISA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of TNF using ELISA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of amyloid A using ELISA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of CRP using ELISA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of D-dimer using ELISA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Potential for Losartan to Reduce the Size of the Viral Reservoir will be assessed by determining the frequency of HIV RNA+ and DNA+ cells in LN using radiolabeled in situ hybridization (ISH).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Potential for Losartan to Reduce the Size of the Viral Reservoir will be assessed by determining the frequency of HIV RNA+ and DNA+ cells in LN using RNAscopeTM in situ technology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Potential for Losartan to Reduce the Size of the Viral Reservoir will be assessed by determining the frequency of HIV RNA+ and DNA+ cells in GALT radiolabeled in situ hybridization (ISH).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
The Potential for Losartan to Reduce the Size of the Viral Reservoir will be assessed by determining the frequency of HIV RNA+ and DNA+ cells in GALT using RNAscopeTM in situ technology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
Potential Drug-drug Interactions Between Losartan and Antiretrovirals (ARVs) will be assessed by measuring levels of ARVs and losartan in plasma and peripheral blood mononuclear cells (PBMCs).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPopulation: This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported.
Potential Drug-drug Interactions Between Losartan and Antiretrovirals (ARVs) will be assessed by measuring intracellular concentration of losartan and ARVs in lympoidtissue.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 monthsPopulation: This exploratory endpoint was not analyzed and data are not available to be reported.
As an exploratory endpoint, we will determine the impact of losartan on frequency of dendritic cell and CD4 T cell interactions with the FRCn. This will be determined using two-photon microscopy in sections on LN obtained from study subjects. Given that this is an exploratory endpoint, these assays will be performed in a subset of subjects (5 losartan treated, 2 placebo treated and 5 HIV uninfected controls).
Outcome measures
Outcome data not reported
Adverse Events
Losartan
Sugar Pill
Serious adverse events
| Measure |
Losartan
n=25 participants at risk
Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months.
|
Sugar Pill
n=27 participants at risk
Placebo: one tablet by mouth daily
|
|---|---|---|
|
General disorders
Hospitalization for Chemotherapy
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
Hospitalization for Illness
|
4.0%
1/25 • Number of events 1 • 30 months
|
18.5%
5/27 • Number of events 6 • 30 months
|
|
General disorders
Hospitalization for Surgery
|
4.0%
1/25 • Number of events 1 • 30 months
|
18.5%
5/27 • Number of events 5 • 30 months
|
|
General disorders
Unintentional Weight Loss
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
Other adverse events
| Measure |
Losartan
n=25 participants at risk
Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months.
|
Sugar Pill
n=27 participants at risk
Placebo: one tablet by mouth daily
|
|---|---|---|
|
Gastrointestinal disorders
Gas, belching
|
8.0%
2/25 • Number of events 3 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Infections and infestations
Food poisoning
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Vascular disorders
Brain aneurysm
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Pain/swelling at incision site
|
12.0%
3/25 • Number of events 3 • 30 months
|
14.8%
4/27 • Number of events 4 • 30 months
|
|
Metabolism and nutrition disorders
Elevated blood glucose
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 2 • 30 months
|
|
Infections and infestations
Sinus infection
|
8.0%
2/25 • Number of events 2 • 30 months
|
7.4%
2/27 • Number of events 4 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Restless leg syndrome diagnoses
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
4.0%
1/25 • Number of events 1 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Jock itch
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
Sciatica, worsened
|
8.0%
2/25 • Number of events 2 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Nervous system disorders
Neuropathy, worsened
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
Fever
|
12.0%
3/25 • Number of events 3 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Infections and infestations
Infected scatch
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.0%
9/25 • Number of events 10 • 30 months
|
25.9%
7/27 • Number of events 10 • 30 months
|
|
General disorders
Headache
|
12.0%
3/25 • Number of events 3 • 30 months
|
7.4%
2/27 • Number of events 2 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Orthopedic injury
|
20.0%
5/25 • Number of events 5 • 30 months
|
7.4%
2/27 • Number of events 2 • 30 months
|
|
Infections and infestations
Neuro-syphillis diagnosis
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Eye disorders
Eye watering
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Number of events 1 • 30 months
|
11.1%
3/27 • Number of events 3 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
8.0%
2/25 • Number of events 2 • 30 months
|
29.6%
8/27 • Number of events 9 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/25 • 30 months
|
7.4%
2/27 • Number of events 2 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Arm pain/numbness
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Cold/flu symptoms
|
8.0%
2/25 • Number of events 2 • 30 months
|
18.5%
5/27 • Number of events 5 • 30 months
|
|
General disorders
Toothache
|
0.00%
0/25 • 30 months
|
7.4%
2/27 • Number of events 2 • 30 months
|
|
Renal and urinary disorders
Urinary urgency
|
8.0%
2/25 • Number of events 2 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Cellulitis
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
Light-headedness
|
12.0%
3/25 • Number of events 3 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Pustular node
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
Mild sleep apnea
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Infections and infestations
Shingles
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Hepatobiliary disorders
Liver cirrhosis
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Fatigue/sluggishness
|
24.0%
6/25 • Number of events 7 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
"Tight" feeling in nose and throat
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.0%
4/25 • Number of events 4 • 30 months
|
11.1%
3/27 • Number of events 5 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
8.0%
2/25 • Number of events 2 • 30 months
|
14.8%
4/27 • Number of events 4 • 30 months
|
|
Eye disorders
Dry eyes
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
Dry mouth/cotton mouth
|
8.0%
2/25 • Number of events 2 • 30 months
|
0.00%
0/27 • 30 months
|
|
Renal and urinary disorders
Urinary tract infection
|
8.0%
2/25 • Number of events 2 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
Benign prostate hypertrophy
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Night sweats
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Diarrhea
|
16.0%
4/25 • Number of events 4 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Dehydration
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Abdominal pain
|
12.0%
3/25 • Number of events 3 • 30 months
|
0.00%
0/27 • 30 months
|
|
Renal and urinary disorders
Kidney stones
|
4.0%
1/25 • Number of events 1 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Fainting episode
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Gastrointestinal disorders
Blood in stool
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
3/25 • Number of events 3 • 30 months
|
0.00%
0/27 • 30 months
|
|
Nervous system disorders
Seizure
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
4.0%
1/25 • Number of events 1 • 30 months
|
3.7%
1/27 • Number of events 3 • 30 months
|
|
General disorders
High blood pressure
|
0.00%
0/25 • 30 months
|
11.1%
3/27 • Number of events 3 • 30 months
|
|
Injury, poisoning and procedural complications
Hot water burn
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Bump at injection site
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Red, swollen area at drug injection site
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain/congestion
|
4.0%
1/25 • Number of events 1 • 30 months
|
11.1%
3/27 • Number of events 3 • 30 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/25 • 30 months
|
7.4%
2/27 • Number of events 2 • 30 months
|
|
General disorders
Sores on gums
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Injury, poisoning and procedural complications
Head injury
|
8.0%
2/25 • Number of events 2 • 30 months
|
7.4%
2/27 • Number of events 2 • 30 months
|
|
Nervous system disorders
Pinched nerve
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Injury, poisoning and procedural complications
Flu vaccine reaction
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
Dizziness
|
4.0%
1/25 • Number of events 1 • 30 months
|
7.4%
2/27 • Number of events 2 • 30 months
|
|
General disorders
Unknown weight loss
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Gastrointestinal disorders
Borborygmus
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Bloody nose
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Renal and urinary disorders
Urinary frequency
|
12.0%
3/25 • Number of events 3 • 30 months
|
0.00%
0/27 • 30 months
|
|
Nervous system disorders
Vertigo
|
4.0%
1/25 • Number of events 1 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Nervous system disorders
Numbness in hand
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Heart burn
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Infections and infestations
Lyme disease
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
Groin pain
|
0.00%
0/25 • 30 months
|
7.4%
2/27 • Number of events 2 • 30 months
|
|
Cardiac disorders
Heart palpitations
|
4.0%
1/25 • Number of events 1 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Infections and infestations
Blastocis hominus
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Vascular disorders
Venous insufficiency
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Number of events 1 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Itchy rash
|
4.0%
1/25 • Number of events 1 • 30 months
|
11.1%
3/27 • Number of events 4 • 30 months
|
|
General disorders
Elevated creatinine
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Insomnia
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Foot callus
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Hand injury
|
0.00%
0/25 • 30 months
|
11.1%
3/27 • Number of events 3 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Increased acne
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Bilateral foot pain
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Surgical and medical procedures
Microdiscectomy
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Infections and infestations
Giardia
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Psychiatric disorders
Depression
|
4.0%
1/25 • Number of events 10 • 30 months
|
0.00%
0/27 • 30 months
|
|
Gastrointestinal disorders
Colon polyp
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Infections and infestations
Syphilis
|
0.00%
0/25 • 30 months
|
7.4%
2/27 • Number of events 2 • 30 months
|
|
General disorders
Temporal mandibular joint pain
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Immune system disorders
Seasonal allergies
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Sleep disturbance
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Rectal pain
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Chest pain
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
Infections and infestations
Increased viral load
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Surgical and medical procedures
Excision of anal lesion
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Multiple sclerosis flare-up
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Cold sore
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
Basal cell carcinoma
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
Infections and infestations
Toe infection
|
0.00%
0/25 • 30 months
|
3.7%
1/27 • Number of events 1 • 30 months
|
|
General disorders
Loss of consciousness during blood draw
|
4.0%
1/25 • Number of events 2 • 30 months
|
0.00%
0/27 • 30 months
|
|
Eye disorders
Conjuctivitis
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
Chills
|
8.0%
2/25 • Number of events 2 • 30 months
|
0.00%
0/27 • 30 months
|
|
Blood and lymphatic system disorders
Low blood pressure
|
4.0%
1/25 • Number of events 1 • 30 months
|
0.00%
0/27 • 30 months
|
|
General disorders
Sore throat
|
8.0%
2/25 • Number of events 3 • 30 months
|
11.1%
3/27 • Number of events 3 • 30 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place