Trial Outcomes & Findings for Adding Maraviroc to Antiretroviral Therapy for Suboptimal CD4 T-Cell Recovery Despite Sustained Virologic Suppression (NCT NCT00709111)
NCT ID: NCT00709111
Last Updated: 2018-10-12
Results Overview
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).
COMPLETED
NA
34 participants
From baseline to week 24
2018-10-12
Participant Flow
Recruited at 29 AIDS Clinical Trials Units in the United States between January 14, 2009 and May 4, 2009
34 enrolled
Participant milestones
| Measure |
Maraviroc
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 Study
STARTED
|
34
|
|
Overall Study
Week 22/24
|
33
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Maraviroc
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 Study
Withdrawal by Subject
|
1
|
|
Overall Study
Unable to attend clinic visits
|
1
|
Baseline Characteristics
Adding Maraviroc to Antiretroviral Therapy for Suboptimal CD4 T-Cell Recovery Despite Sustained Virologic Suppression
Baseline characteristics by cohort
| Measure |
Maraviroc
n=34 Participants
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.
|
|---|---|
|
Age, Continuous
|
50 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
24 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
6 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic (Regardless of Race)
|
4 participants
n=93 Participants
|
|
Baseline CD4+ T-cell count
|
153 cells/mm^3
n=93 Participants
|
|
Baseline CD4 percentage
|
13 % of total lymphocytes
n=93 Participants
|
|
Baseline CD8+ T-cell count
|
559 cells/mm^3
n=93 Participants
|
|
Time with suppressed HIV-1 RNA prior to study entry
|
3.0 years
n=93 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 24Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=32 Participants
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.
|
|---|---|
|
Change in CD4+ T-cell Count
|
12 cells/mm^3
Interval 1.0 to 22.0
|
SECONDARY outcome
Timeframe: From baseline to week 24Population: 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.
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.
Outcome measures
| Measure |
Maraviroc
n=32 Participants
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.
|
|---|---|
|
Proportion of Participants Achieving a 50-cell Increase in CD4+ T-cell Count
|
0.06 proportion of participants
Interval 0.01 to 0.18
|
SECONDARY outcome
Timeframe: From baseline through week 24Population: 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.
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.
Outcome measures
| Measure |
Maraviroc
n=32 Participants
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.
|
|---|---|
|
Within-subject CD4+ T-cell Count Slopes
|
24.7 cells/mm^3/year
Interval 2.9 to 46.4
|
SECONDARY outcome
Timeframe: From pre-treatment through week 24Population: 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.
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.
Outcome measures
| Measure |
Maraviroc
n=32 Participants
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.
|
|---|---|
|
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
|
25.2 cells/mm^3/year
Interval 2.1 to 48.3
|
SECONDARY outcome
Timeframe: From week 24 to week 36Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in CD4+ T-cell Count
|
-3 cells/mm^3
Interval -16.0 to 7.0
|
SECONDARY outcome
Timeframe: From week 24 to week 48Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in CD4+ T-cell Count
|
7 cells/mm^3
Interval -5.0 to 18.0
|
SECONDARY outcome
Timeframe: From baseline to week 24Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=32 Participants
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.
|
|---|---|
|
Change in CD4 Percentage
|
0.5 % of total lymphocytes
Interval 0.0 to 0.9
|
SECONDARY outcome
Timeframe: From baseline through week 24Population: 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.
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.
Outcome measures
| Measure |
Maraviroc
n=28 Participants
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.
|
|---|---|
|
Within-subject CD4 Percentage Slopes
|
-0.3 % of total lymphocytes/year
Interval -2.2 to 1.6
|
SECONDARY outcome
Timeframe: From pre-treatment through week 24Population: 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.
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.
Outcome measures
| Measure |
Maraviroc
n=28 Participants
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.
|
|---|---|
|
Change From Within-subject Pre-treatment CD4 Percentage Slopes to Corresponding Within-subject CD4 Percentage Slopes From Baseline Through Week 24
|
-1.0 % of total lymphocytes/year
Interval -3.0 to 1.1
|
SECONDARY outcome
Timeframe: From week 24 to week 36Population: 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.
Change was calculated as week 36 CD4 percentage minus the week 24 CD4 percentage (average of the week 22 and week 24 values).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in CD4 Percentage
|
0.2 % of total lymphocytes
Interval -0.1 to 1.0
|
SECONDARY outcome
Timeframe: From week 24 to week 48Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in CD4 Percentage
|
0.5 % of total lymphocytes
Interval 0.0 to 1.5
|
SECONDARY outcome
Timeframe: From baseline through week 24Population: As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.
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.
Outcome measures
| Measure |
Maraviroc
n=34 Participants
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.
|
|---|---|
|
Number of Subjects Who Experience a Grade 2, 3 or 4 Signs and Symptoms, Grade 3 or 4 Laboratory Abnormalities, or Death.
grade>=2 signs/symptoms or grade>=3 lab abnorm.
|
15 participants
|
|
Number of Subjects Who Experience a Grade 2, 3 or 4 Signs and Symptoms, Grade 3 or 4 Laboratory Abnormalities, or Death.
deaths
|
0 participants
|
SECONDARY outcome
Timeframe: From baseline to week 24Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=32 Participants
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.
|
|---|---|
|
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+
naïve (%CD45RA+CCR7+)
|
-1.3 % of CD4+ T-cells
Interval -3.0 to 0.3
|
|
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+
central memory (%CD45RA-CCR7+)
|
-4.8 % of CD4+ T-cells
Interval -7.9 to -1.9
|
|
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+
effector memory (%CD45RA-CCR7-)
|
5.8 % of CD4+ T-cells
Interval 2.5 to 10.6
|
|
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+
effector (%CD45RA+CCR7-)
|
0.7 % of CD4+ T-cells
Interval 0.0 to 0.9
|
|
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+
%HLA-DR+CD38+
|
-1.3 % of CD4+ T-cells
Interval -1.8 to -0.3
|
|
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+
%CD38+
|
-14.8 % of CD4+ T-cells
Interval -19.6 to -9.3
|
|
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+
%Ki67+
|
-1.0 % of CD4+ T-cells
Interval -1.5 to -0.5
|
|
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+
%caspase3+
|
-1.1 % of CD4+ T-cells
Interval -1.4 to -0.6
|
|
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+
%Bcl-2-
|
0.7 % of CD4+ T-cells
Interval 0.0 to 1.3
|
|
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+
%CD57+
|
1.8 % of CD4+ T-cells
Interval 1.0 to 2.7
|
SECONDARY outcome
Timeframe: From baseline to week 24Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=32 Participants
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.
|
|---|---|
|
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+
naïve (%CD45RA+CCR7+)
|
-3.3 % of CD8+ T-cells
Interval -5.4 to -1.7
|
|
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+
central memory (%CD45RA-CCR7+)
|
-1.0 % of CD8+ T-cells
Interval -1.9 to -0.5
|
|
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+
effector memory (%CD45RA-CCR7-)
|
2.5 % of CD8+ T-cells
Interval 0.8 to 6.0
|
|
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+
effector (%CD45RA+CCR7-)
|
2.0 % of CD8+ T-cells
Interval 0.2 to 6.6
|
|
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+
%HLA-DR+CD38+
|
-1.4 % of CD8+ T-cells
Interval -3.0 to -0.3
|
|
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+
%CD38+
|
-14.2 % of CD8+ T-cells
Interval -19.5 to -8.7
|
|
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+
%Ki67+
|
-0.1 % of CD8+ T-cells
Interval -0.3 to 0.1
|
|
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+
%caspase3+
|
-0.7 % of CD8+ T-cells
Interval -0.9 to -0.4
|
|
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+
%Bcl-2-
|
0.5 % of CD8+ T-cells
Interval -0.1 to 0.8
|
|
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+
%CD57+
|
3.6 % of CD8+ T-cells
Interval 1.0 to 5.6
|
SECONDARY outcome
Timeframe: From week 24 to week 36Population: 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.
Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
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+
naïve (%CD45RA+CCR7+)
|
3.5 % of CD4+ T-cells
Interval 1.1 to 5.9
|
|
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+
central memory (%CD45RA-CCR7+)
|
-1.4 % of CD4+ T-cells
Interval -3.0 to -0.2
|
|
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+
effector memory (%CD45RA-CCR7-)
|
-3.7 % of CD4+ T-cells
Interval -6.0 to -0.7
|
|
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+
effector (%CD45RA+CCR7-)
|
0.1 % of CD4+ T-cells
Interval -0.3 to 0.8
|
|
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+
%HLA-DR+CD38+
|
-0.2 % of CD4+ T-cells
Interval -0.5 to 0.1
|
|
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+
%CD38+
|
2.8 % of CD4+ T-cells
Interval 0.2 to 3.6
|
|
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+
%Ki67+
|
0.1 % of CD4+ T-cells
Interval -0.2 to 0.5
|
|
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+
%caspase3+
|
0.3 % of CD4+ T-cells
Interval 0.1 to 0.4
|
|
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+
%Bcl-2-
|
-0.6 % of CD4+ T-cells
Interval -0.9 to -0.2
|
|
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+
%CD57+
|
-0.9 % of CD4+ T-cells
Interval -1.7 to -0.5
|
SECONDARY outcome
Timeframe: From week 24 to week 36Population: 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.
Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
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+
naïve (%CD45RA+CCR7+)
|
2.4 % of CD8+ T-cells
Interval 0.6 to 3.8
|
|
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+
central memory (%CD45RA-CCR7+)
|
-0.3 % of CD8+ T-cells
Interval -0.9 to 0.0
|
|
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+
effector memory (%CD45RA-CCR7-)
|
-5.1 % of CD8+ T-cells
Interval -6.7 to -3.5
|
|
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+
effector (%CD45RA+CCR7-)
|
2.4 % of CD8+ T-cells
Interval 0.7 to 4.7
|
|
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+
%HLA-DR+CD38+
|
-0.8 % of CD8+ T-cells
Interval -2.0 to -0.1
|
|
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+
%CD38+
|
-1.6 % of CD8+ T-cells
Interval -5.2 to 3.3
|
|
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+
%Ki67+
|
0.1 % of CD8+ T-cells
Interval -0.2 to 0.2
|
|
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+
%caspase3+
|
0.2 % of CD8+ T-cells
Interval 0.1 to 0.3
|
|
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+
%Bcl-2-
|
-0.3 % of CD8+ T-cells
Interval -0.5 to 0.3
|
|
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+
%CD57+
|
-2.8 % of CD8+ T-cells
Interval -3.3 to -0.9
|
SECONDARY outcome
Timeframe: From week 24 to week 48Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
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+
naïve (%CD45RA+CCR7+)
|
2.1 % of CD4+ T-cells
Interval 1.1 to 3.8
|
|
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+
central memory (%CD45RA-CCR7+)
|
-3.1 % of CD4+ T-cells
Interval -6.8 to -2.0
|
|
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+
effector memory (%CD45RA-CCR7-)
|
0.4 % of CD4+ T-cells
Interval -3.0 to 2.2
|
|
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+
effector (%CD45RA+CCR7-)
|
1.2 % of CD4+ T-cells
Interval 0.7 to 1.9
|
|
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+
%HLA-DR+CD38+
|
0.4 % of CD4+ T-cells
Interval 0.1 to 0.6
|
|
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+
%CD38+
|
7.1 % of CD4+ T-cells
Interval 3.6 to 9.2
|
|
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+
%Ki67+
|
0.1 % of CD4+ T-cells
Interval -0.2 to 0.6
|
|
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+
%caspase3+
|
0.7 % of CD4+ T-cells
Interval 0.3 to 1.0
|
|
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+
%Bcl-2-
|
-0.5 % of CD4+ T-cells
Interval -0.9 to 0.2
|
|
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+
%CD57+
|
-0.4 % of CD4+ T-cells
Interval -0.6 to 0.6
|
SECONDARY outcome
Timeframe: From week 24 to week 48Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
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+
naïve (%CD45RA+CCR7+)
|
1.1 % of CD8+ T-cells
Interval -0.8 to 2.2
|
|
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+
central memory (%CD45RA-CCR7+)
|
-0.5 % of CD8+ T-cells
Interval -1.1 to -0.3
|
|
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+
effector memory (%CD45RA-CCR7-)
|
-0.1 % of CD8+ T-cells
Interval -4.0 to 0.5
|
|
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+
effector (%CD45RA+CCR7-)
|
0.4 % of CD8+ T-cells
Interval -2.1 to 2.1
|
|
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+
%HLA-DR+CD38+
|
0.1 % of CD8+ T-cells
Interval -1.5 to 1.3
|
|
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+
%CD38+
|
4.2 % of CD8+ T-cells
Interval 0.6 to 5.4
|
|
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+
%Ki67+
|
0.2 % of CD8+ T-cells
Interval -0.1 to 0.6
|
|
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+
%caspase3+
|
0.5 % of CD8+ T-cells
Interval 0.2 to 1.1
|
|
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+
%Bcl-2-
|
0 % of CD8+ T-cells
Interval -0.5 to 0.4
|
|
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+
%CD57+
|
-1.4 % of CD8+ T-cells
Interval -3.4 to 1.1
|
SECONDARY outcome
Timeframe: From baseline to week 24Population: 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.
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.
Outcome measures
| Measure |
Maraviroc
n=32 Participants
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.
|
|---|---|
|
Change in Soluble CD14
|
-0.03 mcg/ml
Interval -0.05 to 0.2
|
SECONDARY outcome
Timeframe: From week 24 to week 36Population: 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.
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.
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in Soluble CD14
|
-0.17 mcg/ml
Interval -0.4 to 0.05
|
SECONDARY outcome
Timeframe: From week 24 to week 48Population: 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.
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.
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in Soluble CD14
|
-0.16 mcg/ml
Interval -0.4 to 0.1
|
SECONDARY outcome
Timeframe: From baseline to week 24Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=32 Participants
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.
|
|---|---|
|
Change in High Sensitivity C-reactive Protein (Hs-CRP)
|
0.01 mg/dl
Interval -0.02 to 0.07
|
SECONDARY outcome
Timeframe: From baseline to week 24Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=32 Participants
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.
|
|---|---|
|
Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L)
IL-6
|
0.7 pg/ml
Interval -0.9 to 1.6
|
|
Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L)
MCP-1
|
44.6 pg/ml
Interval -39.6 to 103.1
|
|
Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L)
MCP-2
|
-1.4 pg/ml
Interval -2.4 to 2.2
|
|
Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L)
CD40L
|
-1.8 pg/ml
Interval -45.6 to 43.1
|
SECONDARY outcome
Timeframe: From baseline to week 24Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=32 Participants
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.
|
|---|---|
|
Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9
ICAM-1
|
-25.7 ng/ml
Interval -59.3 to 23.5
|
|
Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9
P-selectin
|
-11.7 ng/ml
Interval -66.2 to 30.5
|
|
Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9
sTNFRII
|
0.18 ng/ml
Interval 0.05 to 0.32
|
|
Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9
MMP-9
|
-12.5 ng/ml
Interval -48.1 to 4.0
|
SECONDARY outcome
Timeframe: From baseline to week 24Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=32 Participants
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.
|
|---|---|
|
Change in D-dimer
|
0.09 mcg/ml
Interval 0.06 to 0.13
|
SECONDARY outcome
Timeframe: From week 24 to week 36Population: 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.
Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in Hs-CRP
|
-0.01 mg/dl
Interval -0.04 to 0.0
|
SECONDARY outcome
Timeframe: From week 24 to week 36Population: 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.
Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in IL-6, MCP-1, MCP-2, and Plasma CD40L
IL-6
|
-0.9 pg/ml
Interval -2.0 to 0.2
|
|
Change in IL-6, MCP-1, MCP-2, and Plasma CD40L
MCP-1
|
-6.9 pg/ml
Interval -146.5 to 78.6
|
|
Change in IL-6, MCP-1, MCP-2, and Plasma CD40L
MCP-2
|
0.1 pg/ml
Interval -3.5 to 3.3
|
|
Change in IL-6, MCP-1, MCP-2, and Plasma CD40L
CD40L
|
0 pg/ml
Interval -11.3 to 65.5
|
SECONDARY outcome
Timeframe: From week 24 to week 36Population: 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.
Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9
ICAM-1
|
-20.9 ng/ml
Interval -43.8 to 7.4
|
|
Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9
P-selectin
|
-13.7 ng/ml
Interval -49.4 to 67.6
|
|
Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9
sTNFRII
|
-0.05 ng/ml
Interval -0.29 to 0.03
|
|
Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9
MMP-9
|
11.3 ng/ml
Interval -18.7 to 39.8
|
SECONDARY outcome
Timeframe: From week 24 to week 36Population: 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.
Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in D-dimer
|
0.01 mcg/ml
Interval -0.05 to 0.05
|
SECONDARY outcome
Timeframe: From week 24 to week 48Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in Hs-CRP
|
0.01 mg/dl
Interval -0.01 to 0.03
|
SECONDARY outcome
Timeframe: From week 24 to week 48Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in IL-6, MCP-1, MCP-2, and Plasma CD40L
IL-6
|
-0.5 pg/ml
Interval -2.1 to 0.6
|
|
Change in IL-6, MCP-1, MCP-2, and Plasma CD40L
MCP-1
|
7.7 pg/ml
Interval -18.5 to 43.2
|
|
Change in IL-6, MCP-1, MCP-2, and Plasma CD40L
MCP-2
|
0.2 pg/ml
Interval -2.1 to 1.8
|
|
Change in IL-6, MCP-1, MCP-2, and Plasma CD40L
CD40L
|
32.3 pg/ml
Interval 0.0 to 66.7
|
SECONDARY outcome
Timeframe: From week 24 to week 48Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9
ICAM-1
|
-32.4 ng/ml
Interval -46.4 to 6.8
|
|
Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9
P-selectin
|
-17.3 ng/ml
Interval -62.1 to 5.2
|
|
Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9
sTNFRII
|
0.03 ng/ml
Interval -0.02 to 0.13
|
|
Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9
MMP-9
|
12.8 ng/ml
Interval -14.9 to 29.5
|
SECONDARY outcome
Timeframe: From week 24 to week 48Population: 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.
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).
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Change in D-dimer
|
-0.02 mcg/ml
Interval -0.03 to 0.01
|
SECONDARY outcome
Timeframe: At weeks -1 (pre-entry), 0 (entry), 12, 22, 24, and 36Population: 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.
A subject was considered detectable at a specific week if HIV-1 RNA by SCA \>=1 copy/ml.
Outcome measures
| Measure |
Maraviroc
n=31 Participants
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.
|
|---|---|
|
Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)
Week -1 (N=31)
|
0.35 proportion of participants
|
|
Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)
Week 0 (N=31)
|
0.32 proportion of participants
|
|
Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)
Week 12 (N=30)
|
0.43 proportion of participants
|
|
Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)
Week 22 (N=31)
|
0.29 proportion of participants
|
|
Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)
Week 24 (N=29)
|
0.48 proportion of participants
|
|
Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)
Week 36 (N=30)
|
0.43 proportion of participants
|
SECONDARY outcome
Timeframe: At weeks 4, 12, and 24Population: As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.
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.
Outcome measures
| Measure |
Maraviroc
n=33 Participants
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.
|
|---|---|
|
Drug Adherence Assessed as Number of Missed Doses Over a 4-day Recall
Week 4 (N=30)
|
0 doses missed
Interval 0.0 to 8.0
|
|
Drug Adherence Assessed as Number of Missed Doses Over a 4-day Recall
Week 12 (N=28)
|
0 doses missed
Interval 0.0 to 4.0
|
|
Drug Adherence Assessed as Number of Missed Doses Over a 4-day Recall
Week 24 (N=27)
|
0 doses missed
Interval 0.0 to 1.0
|
Adverse Events
Maraviroc
Serious adverse events
| Measure |
Maraviroc
n=34 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Bradycardia
|
2.9%
1/34 • From first dose of MVC until off-study
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
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.9%
1/34 • From first dose of MVC until off-study
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
|
|
Infections and infestations
Pneumonia
|
5.9%
2/34 • From first dose of MVC until off-study
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
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.9%
1/34 • From first dose of MVC until off-study
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
|
Other adverse events
| Measure |
Maraviroc
n=34 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
2/34 • From first dose of MVC until off-study
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
|
|
Gastrointestinal disorders
Constipation
|
5.9%
2/34 • From first dose of MVC until off-study
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
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
2/34 • From first dose of MVC until off-study
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
|
|
General disorders
Fatigue
|
11.8%
4/34 • From first dose of MVC until off-study
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
|
|
Infections and infestations
Pneumonia bacterial
|
8.8%
3/34 • From first dose of MVC until off-study
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
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
3/34 • From first dose of MVC until off-study
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
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
2/34 • From first dose of MVC until off-study
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
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
2/34 • From first dose of MVC until off-study
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
|
|
Investigations
Blood albumin abnormal
|
5.9%
2/34 • From first dose of MVC until off-study
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
|
|
Investigations
Blood bilirubin increased
|
14.7%
5/34 • From first dose of MVC until off-study
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
|
|
Investigations
Blood glucose abnormal
|
8.8%
3/34 • From first dose of MVC until off-study
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
|
|
Investigations
Blood glucose increased
|
11.8%
4/34 • From first dose of MVC until off-study
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
|
|
Investigations
Blood sodium decreased
|
8.8%
3/34 • From first dose of MVC until off-study
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
|
|
Investigations
Neutrophil count decreased
|
8.8%
3/34 • From first dose of MVC until off-study
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
|
|
Investigations
Platelet count decreased
|
8.8%
3/34 • From first dose of MVC until off-study
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
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
2/34 • From first dose of MVC until off-study
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
|
|
Psychiatric disorders
Insomnia
|
5.9%
2/34 • From first dose of MVC until off-study
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
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.7%
5/34 • From first dose of MVC until off-study
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
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
5.9%
2/34 • From first dose of MVC until off-study
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
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.8%
3/34 • From first dose of MVC until off-study
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
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
2/34 • From first dose of MVC until off-study
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
|
Additional Information
ACTG ClinicalTrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER