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Adding Maraviroc to Antiretroviral Therapy for Suboptimal CD4 T-Cell Recovery Despite Sustained Virologic Suppression

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ClinicalTrials.gov Identifier: NCT00709111
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : February 24, 2012
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Intervention Drug: Maraviroc
Enrollment 34

Recruitment Details Recruited at 29 AIDS Clinical Trials Units in the United States between January 14, 2009 and May 4, 2009
Pre-assignment Details 34 enrolled
Arm/Group Title Maraviroc
Hide Arm/Group Description Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Period Title: Overall Study
Started 34
Week 22/24 33
Completed 32
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Unable to attend clinic visits             1
Arm/Group Title Maraviroc
Hide Arm/Group Description Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 34 participants
50
(47 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
2
   5.9%
Male
32
  94.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
White Non-Hispanic 24
Black Non-Hispanic 6
Hispanic (Regardless of Race) 4
Baseline CD4+ T-cell count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 34 participants
153
(119 to 203)
[1]
Measure Description: Baseline CD4+ T-cell count is the average (mean) of the pre-entry and entry values
Baseline CD4 percentage   [1] 
Median (Inter-Quartile Range)
Unit of measure:  % of total lymphocytes
Number Analyzed 34 participants
13
(10 to 17)
[1]
Measure Description: Baseline CD4 percentage is the average (mean) of the pre-entry and entry values
Baseline CD8+ T-cell count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 34 participants
559
(416 to 872)
[1]
Measure Description: Baseline CD8+ T-cell count is the average (mean) of the pre-entry and entry values
Time with suppressed HIV-1 RNA prior to study entry   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 34 participants
3.0
(1.8 to 4.5)
[1]
Measure Description: Four (4) participants had no documentation or recall of the date when they became suppressed (HIV-1 RNA <400 copies/ml)
1.Primary Outcome
Title Change in CD4+ T-cell Count
Hide Description Change was calculated as the week 24 CD4+ T-cell count (average of the week 22 and week 24 values) minus the baseline CD4+ T-cell count (average of pre-entry and entry values).
Time Frame From baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 32
Median (90% Confidence Interval)
Unit of Measure: cells/mm^3
12
(1 to 22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc
Comments The change in CD4+ T-cell count from baseline to week 24 was compared against the null hypothesis of change <20 cells/mm^3. The study was powered to yield 80% power to show that there was >=20 cells/mm^3 increase in CD4+ T-cell count assuming an underlying change in CD4+ T-cell counts induced by MVC of 50 cells/mm^3, a standard deviation of 60 cells/mm^3 around the mean CD4+ T-cell count change, 10% lost-to-follow-up or premature MVC discontinuation rate, and one-sided type 1 error of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments The p-value is one-sided with a nominal level of 0.05.
Method Wilcoxon signed-rank, 1-sided
Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Participants Achieving a 50-cell Increase in CD4+ T-cell Count
Hide Description Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.
Time Frame From baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion of participants
0.06
(0.01 to 0.18)
3.Secondary Outcome
Title Within-subject CD4+ T-cell Count Slopes
Hide Description The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.
Time Frame From baseline through week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 32
Mean (90% Confidence Interval)
Unit of Measure: cells/mm^3/year
24.7
(2.9 to 46.4)
4.Secondary Outcome
Title Change From Within-subject Pre-treatment CD4+ T-cell Count Slopes to Corresponding Within-subject CD4+ T-cell Count Slopes From Baseline Through Week 24
Hide Description The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4+ T-cell counts (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.
Time Frame From pre-treatment through week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 32
Mean (90% Confidence Interval)
Unit of Measure: cells/mm^3/year
25.2
(2.1 to 48.3)
5.Secondary Outcome
Title Change in CD4+ T-cell Count
Hide Description Change was calculated as week 36 CD4+ T-cell count minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).
Time Frame From week 24 to week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4+ T-cell count obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: cells/mm^3
-3
(-16 to 7)
6.Secondary Outcome
Title Change in CD4+ T-cell Count
Hide Description Change was calculated as week 48 CD4+ T-cell count (average of week 46 and week 48) minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).
Time Frame From week 24 to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4+ T-cell count or a week 48 CD4+ T-cell count obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: cells/mm^3
7
(-5 to 18)
7.Secondary Outcome
Title Change in CD4 Percentage
Hide Description Change was calculated as the week 24 CD4 percentage (average of the week 22 and week 24 values) minus the baseline CD4 percentage (average of pre-entry and entry values).
Time Frame From baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants with either a week 22 CD4 percentage or a week 24 CD4 percentage obtained while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 32
Median (90% Confidence Interval)
Unit of Measure: % of total lymphocytes
0.5
(0 to 0.9)
8.Secondary Outcome
Title Within-subject CD4 Percentage Slopes
Hide Description The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.
Time Frame From baseline through week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 28
Mean (90% Confidence Interval)
Unit of Measure: % of total lymphocytes/year
-0.3
(-2.2 to 1.6)
9.Secondary Outcome
Title Change From Within-subject Pre-treatment CD4 Percentage Slopes to Corresponding Within-subject CD4 Percentage Slopes From Baseline Through Week 24
Hide Description The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4 percentage (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.
Time Frame From pre-treatment through week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 28
Mean (90% Confidence Interval)
Unit of Measure: % of total lymphocytes/year
-1.0
(-3.0 to 1.1)
10.Secondary Outcome
Title Change in CD4 Percentage
Hide Description Change was calculated as week 36 CD4 percentage minus the week 24 CD4 percentage (average of the week 22 and week 24 values).
Time Frame From week 24 to week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4 percentage obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: % of total lymphocytes
0.2
(-0.1 to 1.0)
11.Secondary Outcome
Title Change in CD4 Percentage
Hide Description Change was calculated as week 48 CD4 percentage (average of week 46 and week 48) minus the week 24 CD4 percentage (average of the week 22 and week 24 values).
Time Frame From week 24 to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4 percentage or a week 48 CD4 percentage obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: % of total lymphocytes
0.5
(0 to 1.5)
12.Secondary Outcome
Title Number of Subjects Who Experience a Grade 2, 3 or 4 Signs and Symptoms, Grade 3 or 4 Laboratory Abnormalities, or Death.
Hide Description Events with date of onset or specimen date prior to first dose of MVC or after the last dose of MVC were excluded. Signs and symptoms with a date of onset the same as the first dose of MVC were excluded if confirmed by the site to be before the first dose. Lab abnormalities with the date of specimen the same as the date of the first dose of MVC were excluded on the assumption that the specimen was drawn before the first dose. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening.
Time Frame From baseline through week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: participants
grade>=2 signs/symptoms or grade>=3 lab abnorm. 15
deaths 0
13.Secondary Outcome
Title Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+
Hide Description Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).
Time Frame From baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 32
Median (90% Confidence Interval)
Unit of Measure: % of CD4+ T-cells
naïve (%CD45RA+CCR7+)
-1.3
(-3.0 to 0.3)
central memory (%CD45RA-CCR7+)
-4.8
(-7.9 to -1.9)
effector memory (%CD45RA-CCR7-)
5.8
(2.5 to 10.6)
effector (%CD45RA+CCR7-)
0.7
(0 to 0.9)
%HLA-DR+CD38+
-1.3
(-1.8 to -0.3)
%CD38+
-14.8
(-19.6 to -9.3)
%Ki67+
-1.0
(-1.5 to -0.5)
%caspase3+
-1.1
(-1.4 to -0.6)
%Bcl-2-
0.7
(0 to 1.3)
%CD57+
1.8
(1.0 to 2.7)
14.Secondary Outcome
Title Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+
Hide Description Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).
Time Frame From baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 32
Median (90% Confidence Interval)
Unit of Measure: % of CD8+ T-cells
naïve (%CD45RA+CCR7+)
-3.3
(-5.4 to -1.7)
central memory (%CD45RA-CCR7+)
-1.0
(-1.9 to -0.5)
effector memory (%CD45RA-CCR7-)
2.5
(0.8 to 6.0)
effector (%CD45RA+CCR7-)
2.0
(0.2 to 6.6)
%HLA-DR+CD38+
-1.4
(-3.0 to -0.3)
%CD38+
-14.2
(-19.5 to -8.7)
%Ki67+
-0.1
(-0.3 to 0.1)
%caspase3+
-0.7
(-0.9 to -0.4)
%Bcl-2-
0.5
(-0.1 to 0.8)
%CD57+
3.6
(1.0 to 5.6)
15.Secondary Outcome
Title Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+
Hide Description Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Time Frame From week 24 to week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: % of CD4+ T-cells
naïve (%CD45RA+CCR7+)
3.5
(1.1 to 5.9)
central memory (%CD45RA-CCR7+)
-1.4
(-3.0 to -0.2)
effector memory (%CD45RA-CCR7-)
-3.7
(-6.0 to -0.7)
effector (%CD45RA+CCR7-)
0.1
(-0.3 to 0.8)
%HLA-DR+CD38+
-0.2
(-0.5 to 0.1)
%CD38+
2.8
(0.2 to 3.6)
%Ki67+
0.1
(-0.2 to 0.5)
%caspase3+
0.3
(0.1 to 0.4)
%Bcl-2-
-0.6
(-0.9 to -0.2)
%CD57+
-0.9
(-1.7 to -0.5)
16.Secondary Outcome
Title Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+
Hide Description Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Time Frame From week 24 to week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: % of CD8+ T-cells
naïve (%CD45RA+CCR7+)
2.4
(0.6 to 3.8)
central memory (%CD45RA-CCR7+)
-0.3
(-0.9 to 0)
effector memory (%CD45RA-CCR7-)
-5.1
(-6.7 to -3.5)
effector (%CD45RA+CCR7-)
2.4
(0.7 to 4.7)
%HLA-DR+CD38+
-0.8
(-2.0 to -0.1)
%CD38+
-1.6
(-5.2 to 3.3)
%Ki67+
0.1
(-0.2 to 0.2)
%caspase3+
0.2
(0.1 to 0.3)
%Bcl-2-
-0.3
(-0.5 to 0.3)
%CD57+
-2.8
(-3.3 to -0.9)
17.Secondary Outcome
Title Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+
Hide Description Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).
Time Frame From week 24 to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: % of CD4+ T-cells
naïve (%CD45RA+CCR7+)
2.1
(1.1 to 3.8)
central memory (%CD45RA-CCR7+)
-3.1
(-6.8 to -2.0)
effector memory (%CD45RA-CCR7-)
0.4
(-3.0 to 2.2)
effector (%CD45RA+CCR7-)
1.2
(0.7 to 1.9)
%HLA-DR+CD38+
0.4
(0.1 to 0.6)
%CD38+
7.1
(3.6 to 9.2)
%Ki67+
0.1
(-0.2 to 0.6)
%caspase3+
0.7
(0.3 to 1.0)
%Bcl-2-
-0.5
(-0.9 to 0.2)
%CD57+
-0.4
(-0.6 to 0.6)
18.Secondary Outcome
Title Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+
Hide Description Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).
Time Frame From week 24 to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: % of CD8+ T-cells
naïve (%CD45RA+CCR7+)
1.1
(-0.8 to 2.2)
central memory (%CD45RA-CCR7+)
-0.5
(-1.1 to -0.3)
effector memory (%CD45RA-CCR7-)
-0.1
(-4.0 to 0.5)
effector (%CD45RA+CCR7-)
0.4
(-2.1 to 2.1)
%HLA-DR+CD38+
0.1
(-1.5 to 1.3)
%CD38+
4.2
(0.6 to 5.4)
%Ki67+
0.2
(-0.1 to 0.6)
%caspase3+
0.5
(0.2 to 1.1)
%Bcl-2-
0
(-0.5 to 0.4)
%CD57+
-1.4
(-3.4 to 1.1)
19.Secondary Outcome
Title Change in Soluble CD14
Hide Description Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values). Soluble CD14 is a marker of gut microbial translocation.
Time Frame From baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 32
Median (90% Confidence Interval)
Unit of Measure: mcg/ml
-0.03
(-0.05 to 0.20)
20.Secondary Outcome
Title Change in Soluble CD14
Hide Description Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.
Time Frame From week 24 to week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: mcg/ml
-0.17
(-0.40 to 0.05)
21.Secondary Outcome
Title Change in Soluble CD14
Hide Description Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.
Time Frame From week 24 to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: mcg/ml
-0.16
(-0.40 to 0.10)
22.Secondary Outcome
Title Change in High Sensitivity C-reactive Protein (Hs-CRP)
Hide Description Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).
Time Frame From baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 32
Median (90% Confidence Interval)
Unit of Measure: mg/dl
0.01
(-0.02 to 0.07)
23.Secondary Outcome
Title Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L)
Hide Description Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).
Time Frame From baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 32
Median (90% Confidence Interval)
Unit of Measure: pg/ml
IL-6
0.7
(-0.9 to 1.6)
MCP-1
44.6
(-39.6 to 103.1)
MCP-2
-1.4
(-2.4 to 2.2)
CD40L
-1.8
(-45.6 to 43.1)
24.Secondary Outcome
Title Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9
Hide Description Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).
Time Frame From baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 32
Median (90% Confidence Interval)
Unit of Measure: ng/ml
ICAM-1
-25.7
(-59.3 to 23.5)
P-selectin
-11.7
(-66.2 to 30.5)
sTNFRII
0.18
(0.05 to 0.32)
MMP-9
-12.5
(-48.1 to 4.0)
25.Secondary Outcome
Title Change in D-dimer
Hide Description Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).
Time Frame From baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 32
Median (90% Confidence Interval)
Unit of Measure: mcg/ml
0.09
(0.06 to 0.13)
26.Secondary Outcome
Title Change in Hs-CRP
Hide Description Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Time Frame From week 24 to week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: mg/dl
-0.01
(-0.04 to 0)
27.Secondary Outcome
Title Change in IL-6, MCP-1, MCP-2, and Plasma CD40L
Hide Description Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Time Frame From week 24 to week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: pg/ml
IL-6
-0.9
(-2.0 to 0.2)
MCP-1
-6.9
(-146.5 to 78.6)
MCP-2
0.1
(-3.5 to 3.3)
CD40L
0
(-11.3 to 65.5)
28.Secondary Outcome
Title Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9
Hide Description Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Time Frame From week 24 to week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: ng/ml
ICAM-1
-20.9
(-43.8 to 7.4)
P-selectin
-13.7
(-49.4 to 67.6)
sTNFRII
-0.05
(-0.29 to 0.03)
MMP-9
11.3
(-18.7 to 39.8)
29.Secondary Outcome
Title Change in D-dimer
Hide Description Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Time Frame From week 24 to week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: mcg/ml
0.01
(-0.05 to 0.05)
30.Secondary Outcome
Title Change in Hs-CRP
Hide Description Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).
Time Frame From week 24 to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: mg/dl
0.01
(-0.01 to 0.03)
31.Secondary Outcome
Title Change in IL-6, MCP-1, MCP-2, and Plasma CD40L
Hide Description Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).
Time Frame From week 24 to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: pg/ml
IL-6
-0.5
(-2.1 to 0.6)
MCP-1
7.7
(-18.5 to 43.2)
MCP-2
0.2
(-2.1 to 1.8)
CD40L
32.3
(0 to 66.7)
32.Secondary Outcome
Title Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9
Hide Description Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).
Time Frame From week 24 to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: ng/ml
ICAM-1
-32.4
(-46.4 to 6.8)
P-selectin
-17.3
(-62.1 to 5.2)
sTNFRII
0.03
(-0.02 to 0.13)
MMP-9
12.8
(-14.9 to 29.5)
33.Secondary Outcome
Title Change in D-dimer
Hide Description Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).
Time Frame From week 24 to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Median (90% Confidence Interval)
Unit of Measure: mcg/ml
-0.02
(-0.03 to 0.01)
34.Secondary Outcome
Title Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)
Hide Description A subject was considered detectable at a specific week if HIV-1 RNA by SCA >=1 copy/ml.
Time Frame At weeks -1 (pre-entry), 0 (entry), 12, 22, 24, and 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Participants who initiated treatment were included. Through week 24, follow-up while receiving MVC without change in background regimen were included. For week 36, only results obtained while receiving background regimen were included. One subject who had a large rise (blip) in viral load at week 24 was excluded.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: proportion of participants
Week -1 (N=31) 0.35
Week 0 (N=31) 0.32
Week 12 (N=30) 0.43
Week 22 (N=31) 0.29
Week 24 (N=29) 0.48
Week 36 (N=30) 0.43
35.Secondary Outcome
Title Drug Adherence Assessed as Number of Missed Doses Over a 4-day Recall
Hide Description Self-reported MVC adherence data were based on a four-day (8 expected doses) recall. Based on the wording of the Self Report case report form (CRF), participants reporting that they were currently taking MVC that then failed to complete the record of the number of missed doses were assumed to have no missed doses to report. Missing adherence assessments at a time point of interest were ignored and only those participants completing an adherence assessment at least one time point of interest were included.
Time Frame At weeks 4, 12, and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.
Arm/Group Title Maraviroc
Hide Arm/Group Description:
Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
Overall Number of Participants Analyzed 33
Median (Full Range)
Unit of Measure: doses missed
Week 4 (N=30)
0
(0 to 8)
Week 12 (N=28)
0
(0 to 4)
Week 24 (N=27)
0
(0 to 1)
Time Frame From first dose of MVC until off-study
Adverse Event Reporting Description Grade>=2 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events & other diseases. Grade>=3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
 
Arm/Group Title Maraviroc
Hide Arm/Group Description Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
All-Cause Mortality
Maraviroc
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Maraviroc
Affected / at Risk (%)
Total   4/34 (11.76%) 
Cardiac disorders   
Bradycardia  1  1/34 (2.94%) 
Gastrointestinal disorders   
Upper gastrointestinal haemorrhage  1  1/34 (2.94%) 
Infections and infestations   
Pneumonia  1  2/34 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Interstitial lung disease  1  1/34 (2.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Maraviroc
Affected / at Risk (%)
Total   22/34 (64.71%) 
Gastrointestinal disorders   
Abdominal distension  1  2/34 (5.88%) 
Constipation  1  2/34 (5.88%) 
Diarrhoea  1  2/34 (5.88%) 
General disorders   
Fatigue  1  4/34 (11.76%) 
Infections and infestations   
Pneumonia bacterial  1  3/34 (8.82%) 
Upper respiratory tract infection  1  3/34 (8.82%) 
Investigations   
Alanine aminotransferase increased  1  2/34 (5.88%) 
Aspartate aminotransferase increased  1  2/34 (5.88%) 
Blood albumin abnormal  1  2/34 (5.88%) 
Blood bilirubin increased  1  5/34 (14.71%) 
Blood glucose abnormal  1  3/34 (8.82%) 
Blood glucose increased  1  4/34 (11.76%) 
Blood sodium decreased  1  3/34 (8.82%) 
Neutrophil count decreased  1  3/34 (8.82%) 
Platelet count decreased  1  3/34 (8.82%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  2/34 (5.88%) 
Psychiatric disorders   
Insomnia  1  2/34 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/34 (14.71%) 
Respiratory tract congestion  1  2/34 (5.88%) 
Sinus congestion  1  3/34 (8.82%) 
Skin and subcutaneous tissue disorders   
Rash  1  2/34 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In accordance with the Clinical Trial Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
Results Point of Contact
Name/Title: ACTG ClinicalTrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Publications of Results:
Wilkin T, Lalama C, Tenorio A, Landay A, Ribaudo H, McKinnon J, Gandhi R, Mellors J, Currier J, and Gulick R. Maraviroc Intensification for Suboptimal CD4+ Cell Response Despite Sustained Virologic Suppression: ACTG 5256. 17th Conference on Retroviruses and Opportunistic Infections, San Francisco, CA, February 16-19, 2010.
Wilkin T, Lalama C, Tenorio A, Landay A, Fox L, McKinnon J, Gandhi R, Mellors J, Currier J, Gulick R. ACTG 5256: Effect of adding and removing maraviroc (MVC) on immune activation in participants on suppressive antiretroviral therapy (ART). 18th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 27-March 02, 2011.
Hilldorfer B, Lalama C, McKinnon J, Coombs B, Tenorio A, Fox L, Gandhi R, Ribaudo H, Currier J, Gulick R, Wilkin TJ, Mellors J. Effects of Maraviroc (MVC) on Residual Low-Level Viremia in Patients on Suppressive Antiretroviral Therapy (ART): Results from ACTG 5256. 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Rome, Italy, July 17-20, 2011.
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00709111     History of Changes
Other Study ID Numbers: ACTG A5256
1U01AI068636 ( U.S. NIH Grant/Contract )
First Submitted: July 1, 2008
First Posted: July 3, 2008
Results First Submitted: July 26, 2011
Results First Posted: February 24, 2012
Last Update Posted: October 12, 2018