Trial Outcomes & Findings for CCR5 Inhibitor Treatment Intensification on CD4+ T-cell Recovery (NCT NCT00925756)
NCT ID: NCT00925756
Last Updated: 2020-08-19
Results Overview
To determine differential gene expression in T-Cells due to MVC exposure between week 0, 4 and 24 weeks. Repeated measures (RM) ANOVA was used to identify genes whose expression changed over the course of MVC administration. Multivariate permutation tests under default settings (80% confident no more than 10% false positives) were performed using BRB-Array Tools. Gene assignment to temporal profiles was performed using a non- parametric clustering algorithm in Short Time-series Expression Miner (STEM)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2020-08-19
Participant Flow
Participant milestones
| Measure |
Maraviroc Intensification
Maraviroc will be added to patient's existing HIV treatment regimen dose-adjusted to background HIV medications
Maraviroc: Maraviroc will be given dose-adjusted to background HIV treatment
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CCR5 Inhibitor Treatment Intensification on CD4+ T-cell Recovery
Baseline characteristics by cohort
| Measure |
Maraviroc Intensification
n=32 Participants
Maraviroc will be added to patient's existing HIV treatment regimen dose-adjusted to background HIV medications
Maraviroc: Maraviroc will be given dose-adjusted to background HIV treatment
|
|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, not Hispanic
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: 32 participants received intervention and were followed for CD4+ counts. 25 of 32 participants had microarray analysis done.
To determine differential gene expression in T-Cells due to MVC exposure between week 0, 4 and 24 weeks. Repeated measures (RM) ANOVA was used to identify genes whose expression changed over the course of MVC administration. Multivariate permutation tests under default settings (80% confident no more than 10% false positives) were performed using BRB-Array Tools. Gene assignment to temporal profiles was performed using a non- parametric clustering algorithm in Short Time-series Expression Miner (STEM)
Outcome measures
| Measure |
Maraviroc Intensification
n=25 Participants
Maraviroc will be added to patient's existing HIV treatment regimen dose-adjusted to background HIV medications
Maraviroc: Maraviroc will be given dose-adjusted to background HIV treatment
|
|---|---|
|
Differences in Gene Expression Profiles Obtained at Baseline and Week 4 and Week 24.
|
1.44 -fold TNF downregulation
|
SECONDARY outcome
Timeframe: Baseline to Week 24To compare the CD4+/CD8+ T-cell absolute count and percentage change at Weeks 4 and 24 from Baseline. Wilcoxon signed rank test was used to assess changes in T cell counts, percentages, CD4+ T cell recovery slopes and changes in T cell phenotypes measured by flow cytometry.
Outcome measures
| Measure |
Maraviroc Intensification
n=32 Participants
Maraviroc will be added to patient's existing HIV treatment regimen dose-adjusted to background HIV medications
Maraviroc: Maraviroc will be given dose-adjusted to background HIV treatment
|
|---|---|
|
CD4+ T-cell Absolute Count and Percentage at Baseline, Weeks 4 and 24.
Wk 4 CD4+ cells (absolute)
|
6.50 cells/mm^3
Interval -21.5 to 32.88
|
|
CD4+ T-cell Absolute Count and Percentage at Baseline, Weeks 4 and 24.
Wk 4 CD8+ cells (absolute)
|
46 cells/mm^3
Interval -41.5 to 96.0
|
|
CD4+ T-cell Absolute Count and Percentage at Baseline, Weeks 4 and 24.
Wk 24 CD4+ cells (absolute)
|
36.75 cells/mm^3
Interval 16.75 to 64.12
|
|
CD4+ T-cell Absolute Count and Percentage at Baseline, Weeks 4 and 24.
Wk 24 CD8+ cells (absolute)
|
100.00 cells/mm^3
Interval 3.25 to 178.88
|
SECONDARY outcome
Timeframe: Baseline to Week 24To compare the percent change of CD4+/CD8+ T-cell
Outcome measures
| Measure |
Maraviroc Intensification
n=32 Participants
Maraviroc will be added to patient's existing HIV treatment regimen dose-adjusted to background HIV medications
Maraviroc: Maraviroc will be given dose-adjusted to background HIV treatment
|
|---|---|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 4 CD4+ total
|
0.62 cells/mm^3
Interval -0.61 to 1.21
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 4 CD4+ naive
|
-0.47 cells/mm^3
Interval -1.64 to 0.99
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 4 CD4+ central memory
|
0.43 cells/mm^3
Interval -1.56 to 4.98
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 4 CD4+ effector memory
|
-0.33 cells/mm^3
Interval -1.81 to 1.0
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 4 CD4+ effector
|
0.00 cells/mm^3
Interval -0.1 to 0.06
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 4 CD4+ immune senescence
|
-0.12 cells/mm^3
Interval -1.16 to 0.46
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 24 CD4+ total
|
1.12 cells/mm^3
Interval -0.55 to 2.64
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 24 CD4+ naive
|
0.52 cells/mm^3
Interval -0.98 to 2.49
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 24 CD4+ central memory
|
-0.15 cells/mm^3
Interval -2.98 to 2.78
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 24 CD4+ effector memory
|
-0.30 cells/mm^3
Interval -2.04 to 0.84
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 24 CD4+ effector
|
0.00 cells/mm^3
Interval -0.15 to 0.15
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 24 CD4+ immune senescence
|
-0.25 cells/mm^3
Interval -0.78 to 0.74
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 4 CD8+ total
|
0.90 cells/mm^3
Interval -0.92 to 2.84
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 4 CD8+ naive
|
-0.45 cells/mm^3
Interval -2.32 to 0.59
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 4 CD8+ central memory
|
0.83 cells/mm^3
Interval -0.16 to 2.26
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 4 CD8+ effector
|
-0.90 cells/mm^3
Interval -3.58 to 1.38
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 4 CD8+ immune senescence
|
-1.83 cells/mm^3
Interval -4.05 to 1.1
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 4 CD8+ effector memory
|
0.73 cells/mm^3
Interval -0.64 to 3.54
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 24 CD8+ total
|
2.38 cells/mm^3
Interval -1.01 to 4.23
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 24 CD8+ naive
|
-0.15 cells/mm^3
Interval -2.15 to 0.96
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 24 CD8+ central memory
|
0.75 cells/mm^3
Interval -0.45 to 1.78
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 24 CD8+ effector memory
|
0.80 cells/mm^3
Interval -0.89 to 2.14
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 24 CD8+ effector
|
-2.68 cells/mm^3
Interval -7.06 to 1.41
|
|
Change in CD4+/CD8+ T-cell Immune Activation, Maturation, Regulatory and Apoptosis Markers at Baseline and Weeks 4 and 24.
Wk 24 CD8+ immune senescence
|
-3.30 cells/mm^3
Interval -8.29 to 0.39
|
Adverse Events
Maraviroc Intensification
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Maraviroc Intensification
n=32 participants at risk
Maraviroc will be added to patient's existing HIV treatment regimen dose-adjusted to background HIV medications
Maraviroc: Maraviroc will be given dose-adjusted to background HIV treatment
|
|---|---|
|
Psychiatric disorders
Altered mental status
|
3.1%
1/32 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place