HIV Infection
Conditions
Keywords
ART, Antiretroviral therapy, Treatment naive, Highly active antiretroviral therapy (HAART)
Brief summary
The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV-infected people who have never received anti-HIV therapy be treated with a triple drug regimen (commonly called combination antiretroviral therapy, cART). Since the introduction of cART, morbidity and mortality among HIV-infected patients has been dramatically reduced. However, metabolic, skeletal, and cardiovascular diseases have been increasingly reported among HIV-infected patients and may be attributable, in part, to the direct effects of cART. Much of our understanding of the development of these diseases, risk factors, and consequences of these disorders has been derived from clinical studies of HIV-infected persons receiving older antiretroviral agents. A5260s was designed to examine the contributions of HIV-disease related factors and impact of newer antiretroviral drugs on the development of metabolic (such as blood vessels, blood sugar, cholesterol), skeletal, and cardiovascular diseases in people who have never received anti-HIV therapy. A5260s is a prospective substudy of a phase III randomized clinical trial A5257 (see ClinicalTrials.gov identifier: NCT00811954). A5257 was designed to look at different combinations of anti-HIV drugs that do not contain the medication efavirenz (EFV) and how well these drug combinations work to decrease the amount of HIV in the blood and to allow immune system recovery in people who have never received anti-HIV therapy. A5257 also examined drug tolerability and safety for the various drug combinations.
Detailed description
A5260s is the optional, metabolic substudy of a phase III, prospective, randomized clinical trial (A5257). For complete details about the parent study A5257, please see ClinicalTrials.gov identifier NCT00811954. Some participants in study A5257 were asked to participate in substudy A5260s. Not all participants were asked since A5260s only took place at a subset of A5257 sites. Participants who agreed to participate in substudy A5260s were enrolled at the same time as their enrollment in A5257. No interventions were given as part of A5260s, but all A5260s participants underwent blood draws, self-administered questionnaire responses (related to physical activity and body image), ultrasound scans to measure the thickness of the carotid artery in the neck and brachial artery flow mediated dilation in the arm, and computerized topography (CT) and dual-energy x-ray absorptiometry (DEXA) scans to measure bone mineral density and body fat. The duration of A5260s study was between 2 and 3 years (96 and 144 weeks), depending on when the participant enrolled. The study was designed to enroll a total of 330 participants with at least 110 per a group; each group represented a different randomized drug combination as defined and assigned by the main study A5257. Cohort A: Atazanavir (ATV) + Ritonavir (RTV) + Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) Cohort B: Raltegravir (RAL) + FTC/TDF Cohort C: Darunavir (DRV) + RTV + FTC/TDF All participants were asked to return for A5260s clinic visits at weeks 4, 24, 48 96 and 144 and participated in all clinical evaluations. No clinical evaluation was restricted to a subset of A5260s participants. If a participant chose to discontinue participation in the substudy, the participant was able to continue in study A5257. However, a participant discontinuing participation from A5257 was also removed from A5260s. Additionally, a participant's decision to discontinue or switch study drugs in the main study did not impact participation and follow-up clinic visits in A5260s.
Interventions
DRUGEmtricitabine/tenofovir disoproxil fumarate
200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs). Other Name: TDF/FTC
DRUGRitonavir
100 mg taken orally once daily. A protease inhibitor (PI). Other Name: RTV
DRUGAtazanavir
300 mg taken orally once daily. A protease inhibitor (PI). Other Name: ATV
DRUGRaltegravir
400 mg taken orally twice daily. An integrase inhibitor (INI). Other Name: RAL
DRUGDarunavir
100 mg taken orally once daily. A protease inhibitor (PI). Other Name: RTV
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrollment in A5257 and intent to enroll in A5001 (ALLRT) * Signed informed consent * For A5257 inclusion criteria, please see ClinicalTrials.gov identifier NCT00811954
Exclusion criteria
* Diabetes mellitus, (fasting plasma glucose ≥ 126 mg/dL on two occasions or on hypoglycemic medications). * Known cardiovascular disease (history of myocardial infarction \[MI\], coronary artery bypass graft surgery, percutaneous coronary intervention, stroke, transient ischemic attack, or peripheral arterial disease with ankle-brachial index of less than 0.9 or claudication) * Uncontrolled hypothyroidism or hyperthyroidism which in the opinion of the site investigator would affect substudy participation * Current use of statins, fish oil (greater than 2 grams per day), fibric acid derivatives, or niacin (more than 1000 mg per day) (NOTE: Current use of fish oil and niacin is defined as receiving treatment in the 8 weeks prior to study entry) * Intention to start pharmacological or surgical intervention for weight loss * Use of any ART in the 30 days before study entry * For A5257
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT) | Study entry, week 144 | 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. |
| Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24 | Study entry, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96 | Study entry, 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. |
| Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96 | Study entry, 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. |
| Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96 | Study entry, 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. |
| Percent Change in Total Limb Fat From Study Entry to Week 96 | Study entry, 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. |
| Percent Change in Trunk Fat From Study Entry to Week 96 | Study entry, 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. |
| Percent Change in Lean Mass From Study Entry to Week 96 | Study entry, 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. |
| Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96 | Study entry, 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. |
| Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96 | Study entry, 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. |
| CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Study entry, 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. |
| Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | 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). |
| Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Study entry, 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). |
| Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48 | Study entry, 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. |
| Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Study entry, 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). |
| Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Study entry, 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). |
| Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Study entry, 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). |
| Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Study entry, 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). |
| Fold Change in D-dimer From Study Entry to Weeks 48 and 96 | Study entry, 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. |
| Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96 | Study entry, 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. |
| Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96 | Study entry, 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. |
| Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96 | Study entry, 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. |
| Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96 | Study entry, 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. |
| Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96 | Study entry, 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). |
| Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96 | Study entry, 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). |
| Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Study entry, 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). |
| Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 | Study entry, 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. |
Countries
United States
Participant flow
Recruitment details
Consented and enrolled at AIDS clinical trials units in the United States. Enrollment occurred between June 1, 2009 (date first participant was enrolled) and April 13, 2011 (date last subject was enrolled).
Pre-assignment details
334 consented and enrolled; 6 participants who initially enrolled were subsequently found ineligible and excluded from all analyses. Results reported for 328 eligible participants.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 109 |
| 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) | 106 |
| 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) | 113 |
| Total | 328 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Completed protocol due to pregnancy | 0 | 0 | 1 |
| Overall Study | Death | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 5 | 3 | 10 |
| Overall Study | Not able to get to clinic | 8 | 5 | 9 |
| Overall Study | Not willing to adhere to requirements | 1 | 2 | 2 |
| Overall Study | Severe Debilitation | 0 | 1 | 0 |
| Overall Study | Withdrew consent prior study completion | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Cohort A: ATV/RTV + FTC/TDF | Cohort B: RAL + FTC/TDF | Cohort C: DRV/RTV + FTC/TDF | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants | 105 Participants | 113 Participants | 325 Participants |
| Age, Continuous | 37 years | 36 years | 35 years | 36 years |
| CD4+ T-cell count | 350 cells/mm^3] | 343 cells/mm^3] | 355 cells/mm^3] | 349 cells/mm^3] |
| HIV-1 RNA | 4.6 log10 copies/mL | 4.5 log10 copies/mL | 4.5 log10 copies/mL | 4.5 log10 copies/mL |
| Race/Ethnicity, Customized American Indian, Alaskan Native | 0 participants | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Asian, Pacific Islander | 2 participants | 5 participants | 1 participants | 8 participants |
| Race/Ethnicity, Customized Black Non-Hispanic | 34 participants | 34 participants | 37 participants | 105 participants |
| Race/Ethnicity, Customized Hispanic (Regardless of Race) | 20 participants | 20 participants | 25 participants | 65 participants |
| Race/Ethnicity, Customized More than one race | 0 participants | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Unknown/missing | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White Non-Hispanic | 53 participants | 43 participants | 48 participants | 144 participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 12 Participants | 34 Participants |
| Sex: Female, Male Male | 99 Participants | 94 Participants | 101 Participants | 294 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Study entry, week 144
Population: Intention to treat; all eligible participants were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT) | 8.2 micron/year |
| Cohort B: RAL + FTC/TDF | Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT) | 10.7 micron/year |
| Cohort C: DRV/RTV + FTC/TDF | Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT) | 12.9 micron/year |
Comparison: 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.p-value: 0.01397.5% CI: [-8.9, -0.4]Mixed Models Analysis
Comparison: 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.p-value: 0.1597.5% CI: [-7, 1.5]Mixed Models Analysis
Comparison: 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.p-value: 0.3197.5% CI: [-2.4, 6.2]Mixed Models Analysis
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.
Time frame: Study entry, week 24
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24 | -0.05 percent |
| Cohort B: RAL + FTC/TDF | Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24 | -0.27 percent |
| Cohort C: DRV/RTV + FTC/TDF | Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24 | 0.15 percent |
Comparison: The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and 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.p-value: 0.5397.5% CI: [-0.63, 1.11]Regression, Linear
Comparison: The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and 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.p-value: 0.5397.5% CI: [-0.98, 0.55]Regression, Linear
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.
Time frame: Study entry, weeks 24, 48, 96 and 144
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Week 24 | 509 cell/mm^3 |
| Cohort A: ATV/RTV + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Study Entry | 350 cell/mm^3 |
| Cohort A: ATV/RTV + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Week 48 | 573 cell/mm^3 |
| Cohort A: ATV/RTV + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Week 144 | 658 cell/mm^3 |
| Cohort A: ATV/RTV + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Week 96 | 634 cell/mm^3 |
| Cohort B: RAL + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Week 144 | 613 cell/mm^3 |
| Cohort B: RAL + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Study Entry | 343 cell/mm^3 |
| Cohort B: RAL + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Week 24 | 445 cell/mm^3 |
| Cohort B: RAL + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Week 48 | 496 cell/mm^3 |
| Cohort B: RAL + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Week 96 | 569 cell/mm^3 |
| Cohort C: DRV/RTV + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Week 48 | 528 cell/mm^3 |
| Cohort C: DRV/RTV + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Study Entry | 355 cell/mm^3 |
| Cohort C: DRV/RTV + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Week 144 | 560 cell/mm^3 |
| Cohort C: DRV/RTV + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Week 24 | 464 cell/mm^3 |
| Cohort C: DRV/RTV + FTC/TDF | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 | Week 96 | 567 cell/mm^3 |
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.
Time frame: Study entry, weeks 4, 24 and 48
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 | Change from study entry to week 24 | -0.002 mm | Standard Deviation 0.103 |
| Cohort A: ATV/RTV + FTC/TDF | Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 | Change from study entry to week 4 | 0.002 mm | Standard Deviation 0.1 |
| Cohort A: ATV/RTV + FTC/TDF | Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 | Change from study entry to week 48 | 0.002 mm | Standard Deviation 0.111 |
| Cohort B: RAL + FTC/TDF | Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 | Change from study entry to week 24 | -0.004 mm | Standard Deviation 0.101 |
| Cohort B: RAL + FTC/TDF | Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 | Change from study entry to week 4 | 0.012 mm | Standard Deviation 0.105 |
| Cohort B: RAL + FTC/TDF | Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 | Change from study entry to week 48 | 0.005 mm | Standard Deviation 0.12 |
| Cohort C: DRV/RTV + FTC/TDF | Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 | Change from study entry to week 4 | -0.005 mm | Standard Deviation 0.102 |
| Cohort C: DRV/RTV + FTC/TDF | Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 | Change from study entry to week 48 | -0.001 mm | Standard Deviation 0.119 |
| Cohort C: DRV/RTV + FTC/TDF | Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 | Change from study entry to week 24 | 0.008 mm | Standard Deviation 0.116 |
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.
Time frame: Study entry, weeks 4 and 48
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48 | Change from study entry to week 4 | -0.04 percent |
| Cohort A: ATV/RTV + FTC/TDF | Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48 | Change from study entry to week 48 | -0.04 percent |
| Cohort B: RAL + FTC/TDF | Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48 | Change from study entry to week 4 | 0.22 percent |
| Cohort B: RAL + FTC/TDF | Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48 | Change from study entry to week 48 | -0.08 percent |
| Cohort C: DRV/RTV + FTC/TDF | Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48 | Change from study entry to week 4 | -0.15 percent |
| Cohort C: DRV/RTV + FTC/TDF | Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48 | Change from study entry to week 48 | -0.11 percent |
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).
Time frame: Study entry to weeks 24, 48, 96, and 144
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change from study entry to week 24 | 161 cell/mm^3 |
| Cohort A: ATV/RTV + FTC/TDF | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change from study entry to week 144 | 305 cell/mm^3 |
| Cohort A: ATV/RTV + FTC/TDF | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change from study entry to week 48 | 209 cell/mm^3 |
| Cohort A: ATV/RTV + FTC/TDF | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change from study entry to week 96 | 280 cell/mm^3 |
| Cohort B: RAL + FTC/TDF | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change from study entry to week 144 | 279 cell/mm^3 |
| Cohort B: RAL + FTC/TDF | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change from study entry to week 24 | 133 cell/mm^3 |
| Cohort B: RAL + FTC/TDF | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change from study entry to week 96 | 247 cell/mm^3 |
| Cohort B: RAL + FTC/TDF | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change from study entry to week 48 | 191 cell/mm^3 |
| Cohort C: DRV/RTV + FTC/TDF | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change from study entry to week 96 | 248 cell/mm^3 |
| Cohort C: DRV/RTV + FTC/TDF | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change from study entry to week 144 | 227 cell/mm^3 |
| Cohort C: DRV/RTV + FTC/TDF | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change from study entry to week 24 | 118 cell/mm^3 |
| Cohort C: DRV/RTV + FTC/TDF | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 | Change from study entry to week 48 | 194 cell/mm^3 |
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).
Time frame: Study entry, weeks 4, 24, 48 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | 0 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 2 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 1 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 2 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | -1 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | -2 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | -1 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | -3 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 6 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | 1 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 3 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 5 mg/dL |
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).
Time frame: Study entry, weeks 4, 24, 48 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | 3 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 4 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 4 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 3 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 6 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | 3 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 4 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 4 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 2 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 4 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 2 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | 2 mg/dL |
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).
Time frame: Study entry, weeks 4, 24, 48 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | -1 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 3 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 2 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 4 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 4 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | -2 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 2 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 3 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 4 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 0 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 1 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | -3 mg/dL |
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).
Time frame: Study entry, weeks 4, 24, 48 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 4.0 uIU/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 3.5 uIU/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 4.0 uIU/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | 4.0 uIU/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 3.0 uIU/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 3.0 uIU/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | 3.0 uIU/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 3.0 uIU/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 2.0 uIU/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | 3.0 uIU/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 2.0 uIU/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 3.0 uIU/dL |
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).
Time frame: Study entry, weeks 4, 24, 48 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 12 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | 4 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 8 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 9 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | -1 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 1 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | -4 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | -7 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 14 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 7 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 12 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | 3 mg/dL |
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).
Time frame: Study entry, weeks 4, 24, 48 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | 14 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 6 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 9 mg/dL |
| Cohort A: ATV/RTV + FTC/TDF | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 10 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | -7 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | -12 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | -13 mg/dL |
| Cohort B: RAL + FTC/TDF | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | -16 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 96 | 0 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 24 | 2 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 48 | 8 mg/dL |
| Cohort C: DRV/RTV + FTC/TDF | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 | Change from study entry to week 4 | 15 mg/dL |
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.
Time frame: Study entry, weeks 48 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in D-dimer From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.57 Fold change |
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in D-dimer From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.52 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in D-dimer From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.73 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in D-dimer From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.72 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in D-dimer From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.65 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in D-dimer From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.65 Fold change |
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.
Time frame: Study entry, weeks 48 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.75 Fold change |
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.85 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.88 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.78 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.78 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 1.31 Fold change |
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.
Time frame: Study entry, weeks 48 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.62 Fold change |
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.89 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.71 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.82 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.75 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.89 Fold change |
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).
Time frame: Study entry, weeks 24 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96 | Fold change from study entry to week 24 | 0.49 Fold change |
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96 | Fold change from study entry to week 96 | 0.38 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96 | Fold change from study entry to week 24 | 0.51 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96 | Fold change from study entry to week 96 | 0.34 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96 | Fold change from study entry to week 24 | 0.52 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96 | Fold change from study entry to week 96 | 0.37 Fold change |
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).
Time frame: Study entry, weeks 24 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96 | Fold change from study entry to week 24 | 0.51 Fold change |
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96 | Fold change from study entry to week 96 | 0.35 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96 | Fold change from study entry to week 24 | 0.56 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96 | Fold change from study entry to week 96 | 0.36 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96 | Fold change from study entry to week 24 | 0.59 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96 | Fold change from study entry to week 96 | 0.38 Fold change |
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.
Time frame: Study entry, weeks 48 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 1.01 Fold change |
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.98 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.91 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.90 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 1.00 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.98 Fold change |
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.
Time frame: Study entry, weeks 48 and 96
Population: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.54 Fold change |
| Cohort A: ATV/RTV + FTC/TDF | Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.51 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.62 Fold change |
| Cohort B: RAL + FTC/TDF | Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.56 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 48 | 0.61 Fold change |
| Cohort C: DRV/RTV + FTC/TDF | Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96 | Fold change from study entry to week 96 | 0.58 Fold change |
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.
Time frame: Study entry, week 96
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96 | -3.7 percent |
| Cohort B: RAL + FTC/TDF | Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96 | -2.2 percent |
| Cohort C: DRV/RTV + FTC/TDF | Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96 | -3.3 percent |
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.
Time frame: Study entry, week 96
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96 | -4.0 percent |
| Cohort B: RAL + FTC/TDF | Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96 | -1.6 percent |
| Cohort C: DRV/RTV + FTC/TDF | Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96 | -3.1 percent |
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.
Time frame: Study entry, week 96
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96 | -1.9 percent |
| Cohort B: RAL + FTC/TDF | Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96 | -0.9 percent |
| Cohort C: DRV/RTV + FTC/TDF | Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96 | -1.0 percent |
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.
Time frame: Study entry, week 96
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Percent Change in Lean Mass From Study Entry to Week 96 | 1.8 percent |
| Cohort B: RAL + FTC/TDF | Percent Change in Lean Mass From Study Entry to Week 96 | 1.7 percent |
| Cohort C: DRV/RTV + FTC/TDF | Percent Change in Lean Mass From Study Entry to Week 96 | 0.1 percent |
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.
Time frame: Study entry, week 96
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96 | 10.3 percent |
| Cohort B: RAL + FTC/TDF | Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96 | 11.8 percent |
| Cohort C: DRV/RTV + FTC/TDF | Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96 | 11.4 percent |
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.
Time frame: Study entry, week 96
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Percent Change in Total Limb Fat From Study Entry to Week 96 | 9.8 percent |
| Cohort B: RAL + FTC/TDF | Percent Change in Total Limb Fat From Study Entry to Week 96 | 6.3 percent |
| Cohort C: DRV/RTV + FTC/TDF | Percent Change in Total Limb Fat From Study Entry to Week 96 | 7.9 percent |
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.
Time frame: Study entry, week 96
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Percent Change in Trunk Fat From Study Entry to Week 96 | 10.8 percent |
| Cohort B: RAL + FTC/TDF | Percent Change in Trunk Fat From Study Entry to Week 96 | 13.5 percent |
| Cohort C: DRV/RTV + FTC/TDF | Percent Change in Trunk Fat From Study Entry to Week 96 | 9.7 percent |
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.
Time frame: Study entry, week 96
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: ATV/RTV + FTC/TDF | Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96 | 10.7 percent |
| Cohort B: RAL + FTC/TDF | Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96 | 16.2 percent |
| Cohort C: DRV/RTV + FTC/TDF | Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96 | 9.5 percent |