Trial Outcomes & Findings for Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 Recovery on Antiretroviral Therapy (NCT NCT01839734)
NCT ID: NCT01839734
Last Updated: 2023-08-30
Results Overview
Summary difference of participant's median iFABP MT marker change at week 4 from baseline aggregate median values
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline and 4 weeks
Results posted on
2023-08-30
Participant Flow
1 participant at screening was not randomized because they declined
Participant milestones
| Measure |
Arm A
4 weeks of treatment with lubiprostone 24 mcg by mouth (PO) once-daily (Interventional Group)
Lubiprostone: Lubiprostone 24 mcg by mouth (PO) once-daily
|
Arm B
No intervention
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
4
|
|
Overall Study
COMPLETED
|
16
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 Recovery on Antiretroviral Therapy
Baseline characteristics by cohort
| Measure |
Arm A
n=16 Participants
4 weeks of treatment with lubiprostone 24 mcg by mouth (PO) once-daily (Interventional Group)
Lubiprostone: Lubiprostone 24 mcg by mouth (PO) once-daily
|
Arm B
n=4 Participants
No intervention
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
49 years
n=7 Participants
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
4 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksSummary difference of participant's median iFABP MT marker change at week 4 from baseline aggregate median values
Outcome measures
| Measure |
Lubiprostone
n=16 Participants
24 ug once daily for 4 weeks
|
Control
n=4 Participants
No medication
|
|---|---|---|
|
Changes in Gut Microbial Translocation (iFABP)
iFABP Baseline
|
145.76 pg/mL
Interval 118.14 to 169.35
|
125.36 pg/mL
Interval 82.43 to 267.76
|
|
Changes in Gut Microbial Translocation (iFABP)
iFABP Week 4
|
151.5 pg/mL
Interval 75.86 to 206.63
|
111.73 pg/mL
Interval 98.44 to 139.84
|
|
Changes in Gut Microbial Translocation (iFABP)
iFABP 4 Week summary difference
|
-9.34 pg/mL
Interval -74.32 to 71.74
|
14.47 pg/mL
Interval -155.83 to 43.93
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksSummary difference of participant's median Zonulin MT marker change at week 4 from baseline aggregate median values.
Outcome measures
| Measure |
Lubiprostone
n=16 Participants
24 ug once daily for 4 weeks
|
Control
n=4 Participants
No medication
|
|---|---|---|
|
Changes in Gut Microbial Translocation (Zonulin)
Zonulin Baseline
|
1 ng/ML
Interval 0.95 to 1.11
|
3.24 ng/ML
Interval 1.46 to 7.14
|
|
Changes in Gut Microbial Translocation (Zonulin)
Zonulin Week 4
|
1.06 ng/ML
Interval 0.83 to 1.88
|
0.98 ng/ML
Interval 0.77 to 2.04
|
|
Changes in Gut Microbial Translocation (Zonulin)
Zonulin 4 Week Summary Difference
|
0.05 ng/ML
Interval -0.08 to 0.15
|
-1.80 ng/ML
Interval -6.16 to 0.37
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksSummary difference of participant's median sCD14 MT marker change at week 4 from baseline aggregate median values
Outcome measures
| Measure |
Lubiprostone
n=16 Participants
24 ug once daily for 4 weeks
|
Control
n=4 Participants
No medication
|
|---|---|---|
|
Changes in Gut Microbial Translocation (sCD14)
sCD14 Baseline
|
10807.06 pg/mL
Interval 9198.0 to 12183.11
|
12370.30 pg/mL
Interval 9548.08 to 13117.2
|
|
Changes in Gut Microbial Translocation (sCD14)
sCD14 Week 4
|
11177.92 pg/mL
Interval 10025.86 to 12108.48
|
11345.27 pg/mL
Interval 8565.97 to 13704.1
|
|
Changes in Gut Microbial Translocation (sCD14)
sCD14 4 Week Summary Difference
|
247.20 pg/mL
Interval -1499.26 to 2414.21
|
-930.48 pg/mL
Interval -1448.47 to 1053.26
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksSummary difference of participant's median sCD163 MT marker change at week 4 from baseline aggregate median values
Outcome measures
| Measure |
Lubiprostone
n=16 Participants
24 ug once daily for 4 weeks
|
Control
n=4 Participants
No medication
|
|---|---|---|
|
Changes in Gut Microbial Translocation (sCD163)
sCD163 Baseline
|
73.09 pg/mL
Interval 54.57 to 92.88
|
51.75 pg/mL
Interval 28.68 to 73.13
|
|
Changes in Gut Microbial Translocation (sCD163)
sCD163 Week 4
|
69.96 pg/mL
Interval 50.61 to 94.16
|
56.74 pg/mL
Interval 29.21 to 90.24
|
|
Changes in Gut Microbial Translocation (sCD163)
sCD163 4 Week Summary Difference
|
-2.56 pg/mL
Interval -10.39 to 6.81
|
4.99 pg/mL
Interval 0.54 to 17.12
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksSummary difference of participant's median IL-6 inflammation marker change at week 4 from baseline aggregate median values.
Outcome measures
| Measure |
Lubiprostone
n=16 Participants
24 ug once daily for 4 weeks
|
Control
n=4 Participants
No medication
|
|---|---|---|
|
Changes in Systemic Inflammation (IL-6)
IL-6 Baseline
|
1.46 pg/mL
Interval 1.11 to 1.66
|
1.72 pg/mL
Interval 1.44 to 6.51
|
|
Changes in Systemic Inflammation (IL-6)
IL-6 Week 4
|
1.67 pg/mL
Interval 1.19 to 2.48
|
2.65 pg/mL
Interval 0.75 to 6.64
|
|
Changes in Systemic Inflammation (IL-6)
IL-6 4 Week Summary Difference
|
-0.12 pg/mL
Interval -0.49 to 0.38
|
-0.68 pg/mL
Interval -1.48 to 0.93
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksSummary difference of participant's median hsCRP inflammation marker change at week 4 from baseline aggregate median values
Outcome measures
| Measure |
Lubiprostone
n=16 Participants
24 ug once daily for 4 weeks
|
Control
n=4 Participants
No medication
|
|---|---|---|
|
Changes in Systemic Inflammation (hsCRP)
hsCRP Baseline
|
25.99 pg/mL
Interval 13.97 to 60.57
|
21.48 pg/mL
Interval 4.73 to 48.47
|
|
Changes in Systemic Inflammation (hsCRP)
hsCRP Week 4
|
27.72 pg/mL
Interval 14.76 to 47.94
|
22.97 pg/mL
Interval 11.53 to 54.39
|
|
Changes in Systemic Inflammation (hsCRP)
hsCRP 4 Week Summary Difference
|
0.51 pg/mL
Interval -4.98 to 6.17
|
6.80 pg/mL
Interval -1.47 to 14.19
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksSummary difference of participant's median CD4+ change at week 4 from baseline aggregate median values
Outcome measures
| Measure |
Lubiprostone
n=16 Participants
24 ug once daily for 4 weeks
|
Control
n=4 Participants
No medication
|
|---|---|---|
|
Changes in Peripheral CD4+
CD4+ 4 Week Summary Difference
|
5.5 cells/mm^3
Interval -27.05 to 24.5
|
-17.5 cells/mm^3
Interval -107.0 to 30.0
|
|
Changes in Peripheral CD4+
CD4+ Baseline
|
333 cells/mm^3
Interval 275.0 to 384.5
|
329.5 cells/mm^3
Interval 229.5 to 379.5
|
|
Changes in Peripheral CD4+
CD4+ Week 4
|
339 cells/mm^3
Interval 269.5 to 405.5
|
230 cells/mm^3
Interval 196.0 to 336.0
|
SECONDARY outcome
Timeframe: 4 weeksSafety monitoring, defined as Grade ≥ 2 signs and symptoms, Grade ≥ 2 laboratory abnormalities, and other serious adverse events (SAEs) not otherwise specified.
Outcome measures
| Measure |
Lubiprostone
n=16 Participants
24 ug once daily for 4 weeks
|
Control
n=4 Participants
No medication
|
|---|---|---|
|
Number of Participants With Adverse Events During Study Period
|
0 Participants
|
0 Participants
|
Adverse Events
Lubiprostone
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lubiprostone
n=16 participants at risk
24 ug once daily for 4 weeks
|
No Intervention
n=4 participants at risk
No medication
|
|---|---|---|
|
Gastrointestinal disorders
Other adverse events
|
50.0%
8/16 • Number of events 8 • 8 weeks
|
0.00%
0/4 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place