Trial Outcomes & Findings for Vitamin E for NASH Treatment in HIV Infected Individuals (NCT NCT03669133)
NCT ID: NCT03669133
Last Updated: 2023-07-25
Results Overview
change in liver steatosis via MRI-PDFF at randomization (day 1) and study completion (week 24) to assess liver steatosis
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
at randomization visit (study day 1) and end of study visit (week 24)
Results posted on
2023-07-25
Participant Flow
3 participants consented to participate in this trial. One person screen-failed and two completed the trial, with one randomized to each arm.
Participant milestones
| Measure |
Vitamin E 800 I/U
Vitamin E 800 I/U daily for 24 weeks
Vitamin E: Vitamin E 800 I/U daily
|
Placebo
Matching placebo for 24 weeks
Placebos: Matching placebo daily
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin E for NASH Treatment in HIV Infected Individuals
Baseline characteristics by cohort
| Measure |
Group A
n=1 Participants
Vitamin E 800 IU/daily for 24 weeks
Vitamin E: Vitamin E 800 IU/daily
|
Group B
n=1 Participants
Matching placebo for 24 weeks
Placebos: Matching placebo daily
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 8.49 • n=99 Participants
|
38 years
STANDARD_DEVIATION 8.49 • n=107 Participants
|
44 years
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at randomization visit (study day 1) and end of study visit (week 24)Population: change in liver steatosis via MRI-PDFF or the one participant in each group
change in liver steatosis via MRI-PDFF at randomization (day 1) and study completion (week 24) to assess liver steatosis
Outcome measures
| Measure |
Vitamin E 800 I/U
n=1 Participants
Vitamin E 800 IU/daily for 24 weeks
Vitamin E: Vitamin E 800 IU/daily
|
Placebo
n=1 Participants
Matching placebo for 24 weeks
Placebos: Matching placebo daily
|
|---|---|---|
|
Percent Change in Liver Fat Content by Magnetic Resonance Proton-Density Fat Fraction
|
0 percentage change
|
4 percentage change
|
SECONDARY outcome
Timeframe: change from baseline (first screening visit) to the end of study visit (week 24)Population: Change in liver stiffness (LSM) via FibroScan for the one participant in each group
This outcome measure reflects the change in liver stiffness in transient elastrography via FibroScan is measured in (kPa) for study participants at two study time points
Outcome measures
| Measure |
Vitamin E 800 I/U
n=1 Participants
Vitamin E 800 IU/daily for 24 weeks
Vitamin E: Vitamin E 800 IU/daily
|
Placebo
n=1 Participants
Matching placebo for 24 weeks
Placebos: Matching placebo daily
|
|---|---|---|
|
Impact of Vitamin E Treatment on Noninvasive Markers of Hepatic Fibrosis
|
-28.3 kPa - kilopascels
|
-0.8 kPa - kilopascels
|
SECONDARY outcome
Timeframe: at randomization visit (study day 1) and end of study visit (week 24)Population: Change in ALT from study randomization (day 1) through the end of study visit (week 24)
This measure reflects the change in ALT(IU/L) value for study participants at two study time points
Outcome measures
| Measure |
Vitamin E 800 I/U
n=1 Participants
Vitamin E 800 IU/daily for 24 weeks
Vitamin E: Vitamin E 800 IU/daily
|
Placebo
n=1 Participants
Matching placebo for 24 weeks
Placebos: Matching placebo daily
|
|---|---|---|
|
Impact of Treatment on ALT as a Noninvasive Marker of Hepatic Inflammation
|
-10 IU/L
|
3 IU/L
|
SECONDARY outcome
Timeframe: Change in AST from study randomization (day 1) through the end of study visit (week 24)Population: one participant completed each group
This measure reflects the change in AST(IU/L) value for study participants at two study time points
Outcome measures
| Measure |
Vitamin E 800 I/U
n=1 Participants
Vitamin E 800 IU/daily for 24 weeks
Vitamin E: Vitamin E 800 IU/daily
|
Placebo
n=1 Participants
Matching placebo for 24 weeks
Placebos: Matching placebo daily
|
|---|---|---|
|
Impact of Treatment on AST as a Noninvasive Marker of Hepatic Inflammation
|
-16 IU/L
|
14 IU/L
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=1 participants at risk
Vitamin E 800 IU/daily for 24 weeks
Vitamin E: Vitamin E 800 IU/daily
|
Group B
n=1 participants at risk
Matching placebo for 24 weeks
Placebos: Matching placebo daily
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COVID
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from the time of enrollment until the end of the study, for a total of 28 weeks.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from the time of enrollment until the end of the study, for a total of 28 weeks.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place