Trial Outcomes & Findings for Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa (NCT NCT01367236)
NCT ID: NCT01367236
Last Updated: 2019-10-21
Results Overview
When commencing antiretroviral therapy (anti-HIV therapy) for the first time, improvements in the function of the brain are frequently observed. For example memory and concentration may improve. However, whether these improvements may differ between different anti-HIV therapies is largely unknown. The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period. Score increase means improved performance of cognitive function
COMPLETED
PHASE4
60 participants
24 weeks, 48 weeks
2019-10-21
Participant Flow
Participant milestones
| Measure |
Standard Boosted
Treatment with:
tenofovir disoproxil fumarate/emtricitabine 300/200mg atazanavir/ritonavir 300/100mg all once daily
|
Maraviroc-intesified Boosted
Treatment with:
abacavir/lamivudine 600/300mg darunavir/ ritonavir 800/100 mg maraviroc 150mg all once daily
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Standard Boosted
Treatment with:
tenofovir disoproxil fumarate/emtricitabine 300/200mg atazanavir/ritonavir 300/100mg all once daily
|
Maraviroc-intesified Boosted
Treatment with:
abacavir/lamivudine 600/300mg darunavir/ ritonavir 800/100 mg maraviroc 150mg all once daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa
Baseline characteristics by cohort
| Measure |
Standard Boosted
n=30 Participants
Treatment with:
tenofovir disoproxil fumarate/emtricitabine 300/200mg atazanavir/ritonavir 300/100mg all once daily
|
Maraviroc-intesified Boosted
n=30 Participants
Treatment with:
abacavir/lamivudine 600/300mg darunavir/ ritonavir 800/100 mg maraviroc 150mg all once daily
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
n=99 Participants
|
35 years
n=107 Participants
|
33 years
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
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 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
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 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 Kingdom
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Baseline CD4+ cell count
|
453 cells/ug
STANDARD_DEVIATION 218 • n=99 Participants
|
429 cells/ug
STANDARD_DEVIATION 240 • n=107 Participants
|
441 cells/ug
STANDARD_DEVIATION 227 • n=206 Participants
|
|
Baseline HIV RNA
|
45 copies/ml 10^3
n=99 Participants
|
51 copies/ml 10^3
n=107 Participants
|
46 copies/ml 10^3
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeks, 48 weeksWhen commencing antiretroviral therapy (anti-HIV therapy) for the first time, improvements in the function of the brain are frequently observed. For example memory and concentration may improve. However, whether these improvements may differ between different anti-HIV therapies is largely unknown. The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period. Score increase means improved performance of cognitive function
Outcome measures
| Measure |
Standard Boosted
n=27 Participants
Treatment with:
tenofovir disoproxil fumarate/emtricitabine 300/200mg atazanavir/ritonavir 300/100mg all once daily
|
Maraviroc-intesified Boosted
n=29 Participants
Treatment with:
abacavir/lamivudine 600/300mg darunavir/ ritonavir 800/100 mg maraviroc 150mg all once daily
|
|---|---|---|
|
Cognitive Function, Global Cognitive Score (Z-score)
24 weeks
|
0.15 z score
Standard Error 0.07
|
0.19 z score
Standard Error 0.07
|
|
Cognitive Function, Global Cognitive Score (Z-score)
48 weeks
|
0.16 z score
Standard Error 0.09
|
0.25 z score
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 48 weeksThe study team will assess the brain functions at each visit. The results of the MRI scans will be compared, changes in N-acetyl aspartate/creatinine ratio over 48 weeks.
Outcome measures
| Measure |
Standard Boosted
n=22 Participants
Treatment with:
tenofovir disoproxil fumarate/emtricitabine 300/200mg atazanavir/ritonavir 300/100mg all once daily
|
Maraviroc-intesified Boosted
n=26 Participants
Treatment with:
abacavir/lamivudine 600/300mg darunavir/ ritonavir 800/100 mg maraviroc 150mg all once daily
|
|---|---|---|
|
Brain Function, Absolute Change Over 48 Weeks of N-acetyl Aspartate/Creatinine Ratio
|
0.071 ratio of N-acetyl aspartate/creatin
Standard Deviation 0.157
|
-0.097 ratio of N-acetyl aspartate/creatin
Standard Deviation 0.185
|
Adverse Events
Standard Boosted
Maraviroc-intesified Boosted
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