Trial Outcomes & Findings for Bone Health in Aging HIV Infected Women (NCT NCT02815566)
NCT ID: NCT02815566
Last Updated: 2024-12-19
Results Overview
The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
Baseline, 48 weeks and 96 weeks
Results posted on
2024-12-19
Participant Flow
Participant milestones
| Measure |
Immediate Switch
Open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for 96 weeks
tenofovir-alafenamide-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
Delayed Switch
Open-label tenofovir (300mg)-emtricitabine (200mg) tablet once daily by mouth for 48 weeks followed by open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for an additional 48 weeks
tenofovir-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
15
|
|
Overall Study
COMPLETED
|
17
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Immediate Switch
Open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for 96 weeks
tenofovir-alafenamide-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
Delayed Switch
Open-label tenofovir (300mg)-emtricitabine (200mg) tablet once daily by mouth for 48 weeks followed by open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for an additional 48 weeks
tenofovir-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Bone Health in Aging HIV Infected Women
Baseline characteristics by cohort
| Measure |
Immediate Switch
n=19 Participants
Open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for 96 weeks
tenofovir-alafenamide-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
Delayed Switch
n=15 Participants
Open-label tenofovir (300mg)-emtricitabine (200mg) tablet once daily by mouth for 48 weeks followed by open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for an additional 48 weeks
tenofovir-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
Total
n=34 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
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
48.8 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
50.6 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 48 weeks and 96 weeksPopulation: Thirty-four women enrolled: 19 in the immediate and 15 in the delayed switch arm between Sept 2017 and April 2019; 30 completed the 96-week protocol. The study closed to follow up March 2021. Two participants in the delayed arm inadvertently switched to TAF at baseline and one participant in the delayed arm remained on TDF for the entire 96 weeks.
The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic.
Outcome measures
| Measure |
Immediate Switch
n=19 Participants
Open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for 96 weeks
tenofovir-alafenamide-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
Delayed Switch
n=15 Participants
Open-label tenofovir (300mg)-emtricitabine (200mg) tablet once daily by mouth for 48 weeks followed by open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for an additional 48 weeks
tenofovir-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
|---|---|---|
|
Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine
48 weeks
|
1.97 Percent Change
Interval -1.15 to 5.49
|
-2.32 Percent Change
Interval -5.11 to 0.19
|
|
Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine
96 weeks
|
2.33 Percent Change
Interval 0.0 to 4.51
|
0.7 Percent Change
Interval -3.19 to 2.47
|
SECONDARY outcome
Timeframe: Baseline, 48 weeks and 96 weeksPopulation: Thirty-four women enrolled: 19 in the immediate and 15 in the delayed switch arm between Sept 2017 and April 2019; 30 completed the 96-week protocol. The study closed to follow up March 2021. Two participants in the delayed arm inadvertently switched to TAF at baseline and one participant in the delayed arm remained on TDF for the entire 96 weeks.
The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic.
Outcome measures
| Measure |
Immediate Switch
n=19 Participants
Open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for 96 weeks
tenofovir-alafenamide-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
Delayed Switch
n=15 Participants
Open-label tenofovir (300mg)-emtricitabine (200mg) tablet once daily by mouth for 48 weeks followed by open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for an additional 48 weeks
tenofovir-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
|---|---|---|
|
% Change in Bone Mineral Density From Baseline at the Femoral Neck
48 weeks
|
1.46 Percent Change
Interval -2.95 to 3.18
|
0.22 Percent Change
Interval -2.83 to 3.64
|
|
% Change in Bone Mineral Density From Baseline at the Femoral Neck
96 weeks
|
2.33 Percent Change
Interval 0.0 to 4.51
|
0.70 Percent Change
Interval -3.19 to 2.47
|
Adverse Events
Immediate Switch
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Switch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Switch
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate Switch
n=19 participants at risk
Open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for 96 weeks
tenofovir-alafenamide-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
Delayed Switch
n=15 participants at risk
Open-label tenofovir (300mg)-emtricitabine (200mg) tablet once daily by mouth for 48 weeks and
tenofovir-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
Delayed Switch
n=15 participants at risk
Open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for an additional 48 weeks.
tenofovir-emtricitabine: comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
|
|---|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
5.3%
1/19 • Number of events 1 • 96 Weeks
Any grade 3 or 4 AE and all fractures that occurred from screening to the end of the study (Week 96 or Early Termination) was captured and recorded.
|
0.00%
0/15 • 96 Weeks
Any grade 3 or 4 AE and all fractures that occurred from screening to the end of the study (Week 96 or Early Termination) was captured and recorded.
|
0.00%
0/15 • 96 Weeks
Any grade 3 or 4 AE and all fractures that occurred from screening to the end of the study (Week 96 or Early Termination) was captured and recorded.
|
|
Nervous system disorders
HIV Encephalitis
|
5.3%
1/19 • Number of events 1 • 96 Weeks
Any grade 3 or 4 AE and all fractures that occurred from screening to the end of the study (Week 96 or Early Termination) was captured and recorded.
|
0.00%
0/15 • 96 Weeks
Any grade 3 or 4 AE and all fractures that occurred from screening to the end of the study (Week 96 or Early Termination) was captured and recorded.
|
0.00%
0/15 • 96 Weeks
Any grade 3 or 4 AE and all fractures that occurred from screening to the end of the study (Week 96 or Early Termination) was captured and recorded.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place