| Primary | Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT) | Right common carotid artery intima-media thickness was measured by ultrasound scan at study entry and weeks 48, 96 and 144. The annual rate of change in right common carotid artery intima-media thickness (CIMT) was estimated over 144 weeks from study entry using mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors. | Intention to treat; all eligible participants were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Mean | 95% Confidence Interval | micron/year | | Study entry, week 144 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF | DRV/RTV + FTC/TDF FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0008.2(5.6 to 10.8)
- OG00110.7(9.2 to 12.2)
- OG00212.9(10.3 to 15.5)
|
|
| | 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 primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons. | Mixed Models Analysis | | 0.013 | Inference was assessed against a type I error of 2.5% to account for multiple comparisons. | Difference in annual rate of change | -4.7 | | | 2-Sided | 97.5 | -8.9 | -0.4 | | | The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort C: DRV/RTV + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors. |
|
| Primary | Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24 | Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments. The change from study entry to week 24 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter. | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | percent | | Study entry, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) |
|
| Secondary | Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48 | Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments. The change from study entry to weeks 4 and 48 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter. | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Mean | 95% Confidence Interval | percent | | Study entry, weeks 4 and 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) |
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| Secondary | Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 | The change in absolute FMD was defined as the maximum absolute FMD from the RH 60 and 90 second measurements, from study entry to weeks 4, 24, and 48 (unit of measure millimeters). All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments. | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Mean | Standard Deviation | mm | | Study entry, weeks 4, 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 |
|
| Secondary | Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96 | Bone mineral density (BMD) of the hip was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. | Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257 | Posted | | Median | Inter-Quartile Range | percent | | Study entry, week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF |
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| Secondary | Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96 | Bone mineral density (BMD) of the lumber spine was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. | Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | percent | | Study entry, week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF |
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| Secondary | Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96 | Bone mineral density (BMD) of the total body was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. | Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | percent | | Study entry, week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF |
|
| Secondary | Percent Change in Total Limb Fat From Study Entry to Week 96 | Total limb fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. | Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | percent | | Study entry, week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF |
|
| Secondary | Percent Change in Trunk Fat From Study Entry to Week 96 | Trunk fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. | Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | percent | | Study entry, week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF | |
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| Secondary | Percent Change in Lean Mass From Study Entry to Week 96 | Lean mass was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. | Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | percent | | Study entry, week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF | |
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| Secondary | Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96 | Visceral abdominal fat (VAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as as ((week 96 value - study entry value) / study entry value)) x 100. | Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | percent | | Study entry, week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF |
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| Secondary | Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96 | Subcutaneous abdominal fat (SAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. | Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | percent | | Study entry, week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF |
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| Secondary | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | The absolute levels of CD4+ T-cell counts (cells/mm^3) measured at study entry and weeks 24, 48, 96 and 144. | Intention to treat; all eligible participants with available data were included. Missing data were assumed missing completely at random. Participants were analyzed per original assigned randomized treatment in ACTG A5257. | Posted | | Median | Inter-Quartile Range | cell/mm^3 | | Study entry, weeks 24, 48, 96 and 144 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF | |
|
| Secondary | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change was calculated as (CD4+ T-cell count at week 24, 48, 96, or 144) - (CD4+ T-cell count at study entry). | Intention to treat; all eligible participants with available data were included. Missing data were assumed missing completely at random. Participants were analyzed per original assigned randomized treatment in ACTG A5257. | Posted | | Median | Inter-Quartile Range | cell/mm^3 | | Study entry to weeks 24, 48, 96, and 144 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF | |
|
| Secondary | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Total cholesterol (TC, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TC was calculated as (week 4, 24, 48 or 96 result) - (study entry result). | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | mg/dL | | Study entry, weeks 4, 24, 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | |
|
| Secondary | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Triglyceride (TG, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TG was calculated as (week 4, 24, 48 or 96 result) - (study entry result). | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | mg/dL | | Study entry, weeks 4, 24, 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 |
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| Secondary | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | HDL cholesterol (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in HDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result). | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | mg/dL | | Study entry, weeks 4, 24, 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | |
|
| Secondary | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Calculated LDL-C (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in calculated LDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result). | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | mg/dL | | Study entry, weeks 4, 24, 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) |
|
| Secondary | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Glucose (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry). | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | mg/dL | | Study entry, weeks 4, 24, 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 |
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| Secondary | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Insulin (unit of measure uIU/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry). | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | uIU/dL | | Study entry, weeks 4, 24, 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 |
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| Secondary | Fold Change in D-dimer From Study Entry to Weeks 48 and 96 | D-dimer was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | Fold change | | Study entry, weeks 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 |
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| Secondary | Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96 | hsCRP was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | Fold change | | Study entry, weeks 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | |
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| Secondary | Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96 | IL-6 was measured at study entry and weeks 48 and 96 (unit of measure pg/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | Fold change | | Study entry, weeks 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 |
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| Secondary | Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96 | Soluble CD14 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | Fold change | | Study entry, weeks 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 |
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| Secondary | Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96 | Soluble CD163 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | Fold change | | Study entry, weeks 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | |
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| Secondary | Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96 | Percent expression of CD38+HLADR+ on CD4+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value). | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | Fold change | | Study entry, weeks 24 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF |
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| Secondary | Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96 | Percent expression of CD38+HLADR+ on CD8+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value). | Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257. | Posted | | Median | Inter-Quartile Range | Fold change | | Study entry, weeks 24 and 96 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: ATV/RTV + FTC/TDF | ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI) | | OG001 | Cohort B: RAL + FTC/TDF | RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI) | | OG002 | Cohort C: DRV/RTV + FTC/TDF |
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