Trial Outcomes & Findings for Targeted Anticoagulation Therapy to Reduce Inflammation and Cellular Activation in Long-term HIV Disease (NCT NCT02339415)
NCT ID: NCT02339415
Last Updated: 2019-09-06
Results Overview
Difference between treatment and control ln-transformed IL-6 plasma levels in change from pre-treatment to on-treatment values
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Through study completion, an average of 4 months on each treatment.
Results posted on
2019-09-06
Participant Flow
Participant milestones
| Measure |
Placebo First Then Edoxaban
Participants receive placebo during first period, then Edoxaban (30mg daily) in second period after washout.
|
Edoxaban First Then Placebo
Participants receive Edoxaban (30mg daily) in first period, then placebo during second period after washout.
|
|---|---|---|
|
First Period
STARTED
|
22
|
22
|
|
First Period
Received at Least One Dose
|
21
|
20
|
|
First Period
COMPLETED
|
20
|
20
|
|
First Period
NOT COMPLETED
|
2
|
2
|
|
Washout
STARTED
|
20
|
20
|
|
Washout
COMPLETED
|
20
|
20
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Second Period
STARTED
|
20
|
20
|
|
Second Period
COMPLETED
|
19
|
18
|
|
Second Period
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeted Anticoagulation Therapy to Reduce Inflammation and Cellular Activation in Long-term HIV Disease
Baseline characteristics by cohort
| Measure |
Placebo First Then Edoxaban
n=22 Participants
Participants receive placebo during first period, then Edoxaban (30mg daily) in second period after washout.
|
Edoxaban First Then Placebo
n=22 Participants
Participants receive Edoxaban (30mg daily) in first period, then placebo during second period after washout.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 8 • n=5 Participants
|
47 years
STANDARD_DEVIATION 10 • n=7 Participants
|
49 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White (Non-Hispanic)
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Systolic Blood Pressure
|
122.4 mmHg
STANDARD_DEVIATION 17.3 • n=5 Participants
|
126.1 mmHg
STANDARD_DEVIATION 13.0 • n=7 Participants
|
124.3 mmHg
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Diastolic Blood Pressure
|
81.4 mmHg
STANDARD_DEVIATION 11.0 • n=5 Participants
|
78.9 mmHg
STANDARD_DEVIATION 10.4 • n=7 Participants
|
80.1 mmHg
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Interleukin-6 (IL-6)
|
0.695 pg/mL
n=5 Participants
|
0.465 pg/mL
n=7 Participants
|
0.575 pg/mL
n=5 Participants
|
|
D-dimer
|
0.18 μg/mL
n=5 Participants
|
0.18 μg/mL
n=7 Participants
|
0.18 μg/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 4 months on each treatment.Population: 44 participants were randomized to each arm, of those, 41 went on to receive placebo and have follow up data, 40 received study drug (Edoxaban) and had follow up data.
Difference between treatment and control ln-transformed IL-6 plasma levels in change from pre-treatment to on-treatment values
Outcome measures
| Measure |
Placebo
n=41 Participants
Matched placebo
|
Edoxaban
n=40 Participants
30mg of Edoxaban
|
|---|---|---|
|
Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 4 Months.
|
-0.02 ln-pg/mL
Standard Deviation 0.39
|
0.09 ln-pg/mL
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Through study completion, an average of 4 months on each treatment.Population: 44 participants were randomized to each arm, of those, 41 went on to receive placebo and have follow up data, 40 received study drug (Edoxaban) and had follow up data.
Difference between treatment and control ln-transformed D-Dimer levels in change from pre-treatment to on-treatment values
Outcome measures
| Measure |
Placebo
n=41 Participants
Matched placebo
|
Edoxaban
n=40 Participants
30mg of Edoxaban
|
|---|---|---|
|
Change in D-Dimer Levels From Baseline to 4 Months
|
-0.13 ln-μg/mL
Standard Deviation 0.77
|
-0.66 ln-μg/mL
Standard Deviation 1.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 months while on Edoxaban or PlaceboNumber of bleeding events on Edoxaban or Placebo.
Outcome measures
| Measure |
Placebo
n=44 Participants
Matched placebo
|
Edoxaban
n=44 Participants
30mg of Edoxaban
|
|---|---|---|
|
Safety (Bleeding Events)
Bruising
|
5 event
|
7 event
|
|
Safety (Bleeding Events)
Bleeding gums
|
3 event
|
10 event
|
|
Safety (Bleeding Events)
Bloody stool
|
3 event
|
4 event
|
|
Safety (Bleeding Events)
Hematuria
|
0 event
|
1 event
|
|
Safety (Bleeding Events)
Epistaxis
|
2 event
|
8 event
|
|
Safety (Bleeding Events)
Laceration
|
2 event
|
5 event
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Edoxaban
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=44 participants at risk
Matched placebo
|
Edoxaban
n=44 participants at risk
30mg of Edoxaban
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
2.3%
1/44 • Number of events 1 • 12 months
|
0.00%
0/44 • 12 months
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Placebo
n=44 participants at risk
Matched placebo
|
Edoxaban
n=44 participants at risk
30mg of Edoxaban
|
|---|---|---|
|
Gastrointestinal disorders
Viral Gastroenteritis
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Vomiting and Diarrhea
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • 12 months
|
|
Injury, poisoning and procedural complications
cut head, slipped on ice
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Iron Deficiency Anemia, unspecified iron deficiency anemia type
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Ruptured L5 disc
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Grade 3 AST due to HCV seroconversion
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Grade 4 ALT due to HCV seroconversion
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Bleeding from a minor dog bite (puppy) with unusual bruising
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Hit by softball, bleeding from eye laceration
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Laceration secondary to coffee pot
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Laceration secondary to meat slicer
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
hematuria
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
General disorders
exhaustion
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
Eye disorders
Acute macular neuroretinopathy
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
|
General disorders
Laceration secondary to syncope
|
2.3%
1/44 • Number of events 1 • 12 months
|
0.00%
0/44 • 12 months
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
2.3%
1/44 • Number of events 1 • 12 months
|
0.00%
0/44 • 12 months
|
|
General disorders
Lightheadedness
|
6.8%
3/44 • Number of events 3 • 12 months
|
0.00%
0/44 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis diagnosis via DEXA on routine clinical screening
|
2.3%
1/44 • Number of events 1 • 12 months
|
0.00%
0/44 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Severe back pain
|
2.3%
1/44 • Number of events 1 • 12 months
|
0.00%
0/44 • 12 months
|
|
Blood and lymphatic system disorders
Bleeding of minor cuts/slow healing
|
2.3%
1/44 • Number of events 1 • 12 months
|
0.00%
0/44 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma
|
2.3%
1/44 • Number of events 1 • 12 months
|
0.00%
0/44 • 12 months
|
|
Blood and lymphatic system disorders
bleeding gums
|
6.8%
3/44 • Number of events 3 • 12 months
|
15.9%
7/44 • Number of events 10 • 12 months
|
|
Blood and lymphatic system disorders
Blood in stool
|
6.8%
3/44 • Number of events 3 • 12 months
|
9.1%
4/44 • Number of events 4 • 12 months
|
|
Blood and lymphatic system disorders
Epistaxis
|
4.5%
2/44 • Number of events 2 • 12 months
|
11.4%
5/44 • Number of events 8 • 12 months
|
|
Blood and lymphatic system disorders
Bruising
|
11.4%
5/44 • Number of events 5 • 12 months
|
15.9%
7/44 • Number of events 7 • 12 months
|
|
Surgical and medical procedures
Tooth extraction
|
4.5%
2/44 • Number of events 2 • 12 months
|
0.00%
0/44 • 12 months
|
|
General disorders
Dizziness
|
4.5%
2/44 • Number of events 2 • 12 months
|
0.00%
0/44 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
4.5%
2/44 • Number of events 2 • 12 months
|
0.00%
0/44 • 12 months
|
|
General disorders
Headache
|
2.3%
1/44 • Number of events 1 • 12 months
|
0.00%
0/44 • 12 months
|
|
Cardiac disorders
Chest pain
|
2.3%
1/44 • Number of events 1 • 12 months
|
0.00%
0/44 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
0.00%
0/44 • 12 months
|
2.3%
1/44 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place