| Primary | Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48 | Mean changes from Baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.) | Treated participants. Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint. | Posted | | Mean | Standard Error | ratio | | Baseline, Week 48 | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
| | | Title | Denominators | Categories |
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| LOCF Population (n=112; n=54) | | | Title | Measurements |
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| - OG0000.02± 0.027
- OG001-0.02± 0.036
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| | OCPopulation (n=105; n=51) | | |
| | 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 |
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| | t-test, 2 sided | | 0.48 | P-value not adjusted for multiple testing, 2-sided 95% CI | Difference in Means | 0.03 | | | | 95 | -0.06 | 0.12 | | | | No | Superiority or Other | | | | |
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| Secondary | Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96 | Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.(Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.) | Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint. | Posted | | Mean | Standard Error | ratio | | Baseline, Week 96 | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA. | The mean percent change from baseline in physical signs of lipohypertrophy, as assessed objectively by changes in visceral adipose tissue (VAT) area (cm2) by computed tomography (CT) scans and by changes in trunk fat (kg) by DEXA. Clinical improvement is associated with a decrease in values. (Baseline values can be found in the Baseline Characteristics section.) | VAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint. | Posted | | Mean | Inter-Quartile Range | Percent change | | Baseline, Week 48, Week 96 | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans | The mean percent change from baseline in physical signs of lipoatrophy, as assessed objectively by changes in peripheral adipose tissue (ie, limb fat (kg) by DEXA and in subcutaneous adipose tissue (SAT) area by CT scans. Clinical improvement is associated with stable values, or an increase in values. (Baseline values can be found in the Baseline Characteristics section.) | SAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before analysis timepoint. | Posted | | Mean | Inter-Quartile Range | percent change | | Baseline, Week 48, Week 96 | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans | The mean percent change from baseline in total body fat by DEXA and in total adipose tissue (TAT) area by CT scans. Total body fat and TAT are both associated many factors (trunk fat + limb fat + other [weight, etc]), and thus clinical improvement cannot be predicted based solely an increase or decrease of these values. (Baseline values can be found in the Baseline Characteristics section.) | TAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint | Posted | | Mean | Inter-Quartile Range | percent change | | Baseline, Week 48, Week 96 | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Mean Percent Changes From Baseline in Fasting Lipids | Mean percent changes from baseline in fasting total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and non-HDL cholesterol, triglycerides, and apolipoprotein B | Treated Subjects (LOCF). n=56 for LDL cholesterol in the PI/RTV arm at both timepoints | Posted | | Number | | Percent change | | Baseline, Week 48, Week 96 | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96 | | Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint. | Posted | | Mean | Standard Error | mg/dL | | Baseline, Week 48, Week 96 | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96 | | Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint. | Posted | | Mean | Standard Error | microunits per milliliter | | Baseline, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | HOMA-IR is an index used in evaluation of obese patients at risk for type 2 diabetes which requires fasting glucose and insulin concentrations. It is a mathematical model based on the theory of a negative feedback loop between the liver and β-cells that regulates both fasting glucose and insulin concentrations and can be used to estimate pancreatic β-cell function and degree of insulin resistance. HOMA-IR normal values are between 2 and 2.5. HOMA-IR ≥ 2.5 indicates insulin-resistance. | Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint. | Posted | | Mean | Standard Error | mg/dL x uU/mL | | Baseline, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Mean Changes From Baseline in Body Weight at Week 48 and Week 96 | | LOCF; n=number of participants with baseline value and value at or before analysis timepoint | Posted | | Mean | Standard Error | kg | | Baseline, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96 | | LOCF; n=number of participants with baseline value and value at or before analysis timepoint | Posted | | Mean | Standard Error | cm | | Baseline, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96 | | LOCF; n=number of participants with baseline value and value at or before analysis timepoint | Posted | | Mean | Standard Error | kg/m2 | | Baseline, Week 48, Week 96 | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96 | Mean changes from baseline in proportion of waist to hip measurements. | LOCF; n=number of participants with baseline value and value at or before analysis timepoint | Posted | | Mean | Standard Error | ratio | | Baseline, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation | Percentage of Participants with AEs, Serious AEs (SAEs), Deaths, and AEs leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. | | Posted | | Number | | Percentage of Participants | | Through Week 96 of study therapy | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Percentage of Participants With Abnormal Liver Function Tests | Percentage of participants with Abnormal Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBILI) measurements. Values for liver tests are graded using the modified World Health Organization (WHO) criteria. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life threatening or disabling. | | Posted | | Number | | Percentage of Participants | | Week 48, Week 96 | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation | Percentage of Participants with AEs leading to discontinuation of study therapy. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. All events listed in this table were SAEs, except for renal impairment and hypertriglycerideamia, which were an AEs (and did not meet the 5 percent threshold reported in Adverse Event module of this record). | | Posted | | Number | | Percent of Participants | | Through Week 96 | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline | Virologic rebound was measured from the first dose of study therapy to the first of the 2 consecutive measurements ≥400 c/mL. Time to virologic rebound was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative proportion of participants without virologic rebound up to the end of the respective interval. | Treated subjects with HIV RNA <400 c/mL at baseline. | Posted | | Number | | Proportion of participants | | Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96 | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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| Secondary | Mean Change From Baseline in CD4 Count | Mean change from baseline in CD4 count among treated subjects | | Posted | | Mean | Standard Error | cells/mm3 | | Baseline, Week 48, Week 96 | | | | ID | Title | Description |
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| OG000 | ATV/RTV Switch Arm | Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs). | | OG001 | PI/RTV Control Arm | Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs. |
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