| Primary | Change in CD4+ T-cell Count | 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). | 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. | Posted | | Median | 90% Confidence Interval | cells/mm^3 | | From baseline to week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | | Title | Denominators | Categories |
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| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| 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. | Wilcoxon signed-rank, 1-sided | | 0.97 | The p-value is one-sided with a nominal level of 0.05. | | | | | | | | | | | | | Superiority or Other |
|
| Secondary | Proportion of Participants Achieving a 50-cell Increase in CD4+ T-cell Count | 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. | 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. | Posted | | Number | 90% Confidence Interval | proportion of participants | | From baseline to week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Within-subject CD4+ T-cell Count Slopes | 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. | 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. | Posted | | Mean | 90% Confidence Interval | cells/mm^3/year | | From baseline through week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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 | 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. | 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. | Posted | | Mean | 90% Confidence Interval | cells/mm^3/year | | From pre-treatment through week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in CD4+ T-cell Count | 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). | 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. | Posted | | Median | 90% Confidence Interval | cells/mm^3 | | From week 24 to week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in CD4+ T-cell Count | 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). | 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. | Posted | | Median | 90% Confidence Interval | cells/mm^3 | | From week 24 to week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in CD4 Percentage | 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). | 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. | Posted | | Median | 90% Confidence Interval | % of total lymphocytes | | From baseline to week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Within-subject CD4 Percentage Slopes | 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. | 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. | Posted | | Mean | 90% Confidence Interval | % of total lymphocytes/year | | From baseline through week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change From Within-subject Pre-treatment CD4 Percentage Slopes to Corresponding Within-subject CD4 Percentage Slopes From Baseline Through Week 24 | 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. | 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. | Posted | | Mean | 90% Confidence Interval | % of total lymphocytes/year | | From pre-treatment through week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in CD4 Percentage | Change was calculated as week 36 CD4 percentage minus the week 24 CD4 percentage (average of the week 22 and week 24 values). | 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. | Posted | | Median | 90% Confidence Interval | % of total lymphocytes | | From week 24 to week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in CD4 Percentage | 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). | 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. | Posted | | Median | 90% Confidence Interval | % of total lymphocytes | | From week 24 to week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Number of Subjects Who Experience a Grade 2, 3 or 4 Signs and Symptoms, Grade 3 or 4 Laboratory Abnormalities, or Death. | 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. | As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included. | Posted | | Number | | participants | | From baseline through week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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+ | 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). | 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. | Posted | | Median | 90% Confidence Interval | % of CD4+ T-cells | | From baseline to week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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+ | 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). | 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. | Posted | | Median | 90% Confidence Interval | % of CD8+ T-cells | | From baseline to week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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+ | Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). | 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. | Posted | | Median | 90% Confidence Interval | % of CD4+ T-cells | | From week 24 to week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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+ | Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). | 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. | Posted | | Median | 90% Confidence Interval | % of CD8+ T-cells | | From week 24 to week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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+ | 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). | 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. | Posted | | Median | 90% Confidence Interval | % of CD4+ T-cells | | From week 24 to week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | 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+ | 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). | 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. | Posted | | Median | 90% Confidence Interval | % of CD8+ T-cells | | From week 24 to week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in Soluble CD14 | 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. | 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. | Posted | | Median | 90% Confidence Interval | mcg/ml | | From baseline to week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in Soluble CD14 | 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. | 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. | Posted | | Median | 90% Confidence Interval | mcg/ml | | From week 24 to week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in Soluble CD14 | 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. | 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. | Posted | | Median | 90% Confidence Interval | mcg/ml | | From week 24 to week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in High Sensitivity C-reactive Protein (Hs-CRP) | 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). | 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. | Posted | | Median | 90% Confidence Interval | mg/dl | | From baseline to week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L) | 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). | 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. | Posted | | Median | 90% Confidence Interval | pg/ml | | From baseline to week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9 | 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). | 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. | Posted | | Median | 90% Confidence Interval | ng/ml | | From baseline to week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in D-dimer | 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). | 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. | Posted | | Median | 90% Confidence Interval | mcg/ml | | From baseline to week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in Hs-CRP | Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). | 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. | Posted | | Median | 90% Confidence Interval | mg/dl | | From week 24 to week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in IL-6, MCP-1, MCP-2, and Plasma CD40L | Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). | 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. | Posted | | Median | 90% Confidence Interval | pg/ml | | From week 24 to week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9 | Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). | 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. | Posted | | Median | 90% Confidence Interval | ng/ml | | From week 24 to week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in D-dimer | Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). | 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. | Posted | | Median | 90% Confidence Interval | mcg/ml | | From week 24 to week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in Hs-CRP | 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). | 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. | Posted | | Median | 90% Confidence Interval | mg/dl | | From week 24 to week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in IL-6, MCP-1, MCP-2, and Plasma CD40L | 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). | 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. | Posted | | Median | 90% Confidence Interval | pg/ml | | From week 24 to week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9 | 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). | 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. | Posted | | Median | 90% Confidence Interval | ng/ml | | From week 24 to week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Change in D-dimer | 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). | 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. | Posted | | Median | 90% Confidence Interval | mcg/ml | | From week 24 to week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA) | A subject was considered detectable at a specific week if HIV-1 RNA by SCA >=1 copy/ml. | 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. | Posted | | Number | | proportion of participants | | At weeks -1 (pre-entry), 0 (entry), 12, 22, 24, and 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Drug Adherence Assessed as Number of Missed Doses Over a 4-day Recall | 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. | As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included. | Posted | | Median | Full Range | doses missed | | At weeks 4, 12, and 24 | | | | ID | Title | Description |
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| OG000 | 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. |
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