Trial Outcomes & Findings for Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF) (NCT NCT03251144)
NCT ID: NCT03251144
Last Updated: 2022-05-10
Results Overview
Change in mitochondrial function \[abnormal mitochondrial dynamics \[(cellular oxygen consumption (COC)\] over 12 months after switch of antiretrovirals.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
12 month visit after switch
Results posted on
2022-05-10
Participant Flow
Assignment based on inclusion criteria TAF based vs TDF based antivirals
Participant milestones
| Measure |
TAF Based ART
HIV infected persons who receive TAF based ART
|
TDF Based ART
HIV infected persons who receive TDF based ART
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
11
|
|
Overall Study
COMPLETED
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF)
Baseline characteristics by cohort
| Measure |
TAF Based ART
n=15 Participants
HIV infected persons who receive TAF based ART
|
TDF Based ART
n=11 Participants
HIV infected persons who receive TDF based ART
|
Total
n=26 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
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 month visit after switchChange in mitochondrial function \[abnormal mitochondrial dynamics \[(cellular oxygen consumption (COC)\] over 12 months after switch of antiretrovirals.
Outcome measures
| Measure |
TAF Based ART
n=15 Participants
HIV infected persons who receive TAF based ART
|
TDF Based ART
n=11 Participants
HIV infected persons who receive TDF based ART
|
|---|---|---|
|
Change in Mitochondrial Function [Cellular Oxygen Consumption (COC)] Over 12 Months After Switch of Antiretrovirals.
|
50 pmoles O2/min
Interval 42.0 to 58.0
|
70 pmoles O2/min
Interval 65.0 to 72.0
|
Adverse Events
TAF Based ART
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TDF Based ART
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place