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)

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

24 weeks, 48 weeks

Results posted on

2019-10-21

Participant Flow

Participant milestones

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

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

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=5 Participants	35 years n=7 Participants	33 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	29 Participants n=7 Participants	58 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	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 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 Kingdom	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Baseline CD4+ cell count	453 cells/ug STANDARD_DEVIATION 218 • n=5 Participants	429 cells/ug STANDARD_DEVIATION 240 • n=7 Participants	441 cells/ug STANDARD_DEVIATION 227 • n=5 Participants
Baseline HIV RNA	45 copies/ml 10^3 n=5 Participants	51 copies/ml 10^3 n=7 Participants	46 copies/ml 10^3 n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks, 48 weeks

Outcome measures

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 weeks

The 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

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Maraviroc-intesified Boosted

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

Professor Alan Winston

Imperial College London

Phone: +44 (0)20 3312 1603

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place