Trial Outcomes & Findings for Effects of Switching Efavirenz to Raltegravir on Vascular Function and Bone Markers in HIV-infected Patients (NCT NCT01270802)
NCT ID: NCT01270802
Last Updated: 2013-12-18
Results Overview
Change in FMD is a measure of change in endothelial function
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2013-12-18
Participant Flow
Enrollment into this trial occurred between April 2011 and May 2012. Participants were recruited from the HIV outpatient clinics associated with the Indiana University Health medical system.
Thirty-two persons screened for enrollment. Two of these failed screening (both for having screening HIV-1 RNA levels \>50 copies/mL); the remaining 30 were equally randomized into the two study groups.
Participant milestones
| Measure |
Continued Tenofovir/Emtricitabine/Efavirenz
Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz (as Atripla) one pill per day
|
Switch to Tenofovir/Emtricitabine Plus Raltegravir
Tenofovir/emtricitabine/raltegravir : Tenofovir/emtricitabine/efavirenz (as Atripla one pill per day) will be switched to tenofovir/emtricitabine (as Truvada one pill per day) plus raltegravir (as Isentress) 400mg orally twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Continued Tenofovir/Emtricitabine/Efavirenz
Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz (as Atripla) one pill per day
|
Switch to Tenofovir/Emtricitabine Plus Raltegravir
Tenofovir/emtricitabine/raltegravir : Tenofovir/emtricitabine/efavirenz (as Atripla one pill per day) will be switched to tenofovir/emtricitabine (as Truvada one pill per day) plus raltegravir (as Isentress) 400mg orally twice daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Effects of Switching Efavirenz to Raltegravir on Vascular Function and Bone Markers in HIV-infected Patients
Baseline characteristics by cohort
| Measure |
Continued Tenofovir/Emtricitabine/Efavirenz
n=15 Participants
Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
|
Switch to Tenofovir/Emtricitabine/Raltegravir
n=15 Participants
Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir
Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine
|
Total
n=30 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
|
15 Participants
n=7 Participants
|
30 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
|
38 years
STANDARD_DEVIATION 12 • n=5 Participants
|
39 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
39 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: In the Switch to tenofovir/emtricitabine plus raltegravir arm, two FMD measurements at 24 weeks were removed from the analysis due to poor quality imaging.
Change in FMD is a measure of change in endothelial function
Outcome measures
| Measure |
Continued Tenofovir/Emtricitabine/Efavirenz
n=13 Participants
Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
|
Switch to Tenofovir/Emtricitabine Plus Raltegravir
n=12 Participants
Tenofovir/emtricitabine plus raltegravir 400mg orally twice daily
|
|---|---|---|
|
Change in Flow-mediated Dilation (FMD) of the Brachial Artery
|
-0.67 % change from baseline
Standard Deviation 3.35
|
-0.1 % change from baseline
Standard Deviation 3.26
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksChange in serum levels of 24-OH-vitamin D provide a measure of the amount of change in vitamin D in the body
Outcome measures
| Measure |
Continued Tenofovir/Emtricitabine/Efavirenz
n=13 Participants
Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
|
Switch to Tenofovir/Emtricitabine Plus Raltegravir
n=14 Participants
Tenofovir/emtricitabine plus raltegravir 400mg orally twice daily
|
|---|---|---|
|
Change in Serum Levels of Vitamin D
|
0.06 ng/mL
Standard Deviation 0.23
|
0.14 ng/mL
Standard Deviation 0.25
|
Adverse Events
Continued Tenofovir/Emtricitabine/Efavirenz
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Switch to Tenofovir/Emtricitabine/Raltegravir
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 |
Continued Tenofovir/Emtricitabine/Efavirenz
n=15 participants at risk
Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
|
Switch to Tenofovir/Emtricitabine/Raltegravir
n=15 participants at risk
Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir
Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine
|
|---|---|---|
|
Infections and infestations
Virologic failure
|
6.7%
1/15 • Number of events 1 • 6 months
Laboratory toxicities were assessed at week 8 and week 24.
|
0.00%
0/15 • 6 months
Laboratory toxicities were assessed at week 8 and week 24.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/15 • 6 months
Laboratory toxicities were assessed at week 8 and week 24.
|
6.7%
1/15 • Number of events 1 • 6 months
Laboratory toxicities were assessed at week 8 and week 24.
|
|
Endocrine disorders
Impaired fasting glucose
|
6.7%
1/15 • Number of events 1 • 6 months
Laboratory toxicities were assessed at week 8 and week 24.
|
0.00%
0/15 • 6 months
Laboratory toxicities were assessed at week 8 and week 24.
|
|
Vascular disorders
Diastolic hypertension
|
6.7%
1/15 • Number of events 1 • 6 months
Laboratory toxicities were assessed at week 8 and week 24.
|
0.00%
0/15 • 6 months
Laboratory toxicities were assessed at week 8 and week 24.
|
Additional Information
Dr. Samir K. Gupta, Principal Investigator
Indiana University School of Medicine
Phone: 317-274-7926
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place