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Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters

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ClinicalTrials.gov Identifier: NCT00851799
Recruitment Status : Completed
First Posted : February 26, 2009
Results First Posted : January 13, 2016
Last Update Posted : January 13, 2016
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition HIV Infection
Interventions Drug: Emtricitabine/tenofovir disoproxil fumarate
Drug: Ritonavir
Drug: Atazanavir
Drug: Raltegravir
Drug: Darunavir
Enrollment 334
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.
Arm/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description

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)

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)

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)

Period Title: Overall Study
Started 109 106 113
Completed 93 93 89
Not Completed 16 13 24
Reason Not Completed
Death             1             0             1
Lost to Follow-up             5             3             10
Not able to get to clinic             8             5             9
Not willing to adhere to requirements             1             2             2
Withdrew consent prior study completion             1             2             1
Severe Debilitation             0             1             0
Completed protocol due to pregnancy             0             0             1
Arm/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF Total
Hide Arm/Group Description

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)

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)

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)

Total of all reporting groups
Overall Number of Baseline Participants 109 106 113 328
Hide Baseline Analysis Population Description
All eligible participants were included in the baseline characteristics.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 106 participants 113 participants 328 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
107
  98.2%
105
  99.1%
113
 100.0%
325
  99.1%
>=65 years
2
   1.8%
1
   0.9%
0
   0.0%
3
   0.9%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 109 participants 106 participants 113 participants 328 participants
37
(31 to 45)
36
(27 to 44)
35
(27 to 46)
36
(28 to 45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 106 participants 113 participants 328 participants
Female
10
   9.2%
12
  11.3%
12
  10.6%
34
  10.4%
Male
99
  90.8%
94
  88.7%
101
  89.4%
294
  89.6%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants 106 participants 113 participants 328 participants
White Non-Hispanic 53 43 48 144
Black Non-Hispanic 34 34 37 105
Hispanic (Regardless of Race) 20 20 25 65
Asian, Pacific Islander 2 5 1 8
American Indian, Alaskan Native 0 2 1 3
More than one race 0 1 1 2
Unknown/missing 0 1 0 1
[1]
Measure Description: Race/Ethnicity was collected prior to study entry.
HIV-1 RNA   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 109 participants 106 participants 113 participants 328 participants
4.6
(4.0 to 5.1)
4.5
(4.1 to 5.1)
4.5
(4.0 to 4.9)
4.5
(4.0 to 5.1)
[1]
Measure Description: HIV-1 RNA was calculated as the geometric mean of the two most recent HIV-1 RNA (log 10 copies/mL) obtained on or before study entry. In the event that these two values differed by more than 1 log10 copy/mL, the outlying value (based on review of all HIV-1 RNA levels available prior to study entry by the study virologist) was excluded with the baseline level determined by the remaining sample. Note that screening HIV-1 RNA values were not used in the calculation of baseline HIV-1 RNA levels.
CD4+ T-cell count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3]
Number Analyzed 109 participants 106 participants 113 participants 328 participants
350
(211 to 461)
343
(185 to 445)
355
(207 to 461)
349
(203 to 455)
[1]
Measure Description: CD4+ T-cell counts were calculated as the mean of the two most recent values available on or before study entry.
1.Primary Outcome
Title Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 109 106 113
Mean (95% Confidence Interval)
Unit of Measure: micron/year
8.2
(5.6 to 10.8)
10.7
(9.2 to 12.2)
12.9
(10.3 to 15.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: ATV/RTV + FTC/TDF, Cohort C: DRV/RTV + FTC/TDF
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments Inference was assessed against a type I error of 2.5% to account for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in annual rate of change
Estimated Value -4.7
Confidence Interval (2-Sided) 97.5%
-8.9 to -0.4
Estimation Comments The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort C: DRV/RTV + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: ATV/RTV + FTC/TDF, Cohort B: RAL + FTC/TDF
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments Inference was assessed against a type I error of 2.5% to account for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in annual rate of change
Estimated Value -2.8
Confidence Interval (2-Sided) 97.5%
-7.0 to 1.5
Estimation Comments The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort B: RAL + FTC/TDF, Cohort C: DRV/RTV + FTC/TDF
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments Inference was assessed against a type I error of 2.5% to account for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in annual rate of change
Estimated Value 1.9
Confidence Interval (2-Sided) 97.5%
-2.4 to 6.2
Estimation Comments The difference in the rate of CIMT change (Cohort C: DRV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.
2.Primary Outcome
Title Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 103 102 107
Median (Inter-Quartile Range)
Unit of Measure: percent
-0.05
(-1.51 to 1.60)
-0.27
(-1.61 to 1.55)
0.15
(-1.39 to 1.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: ATV/RTV + FTC/TDF, Cohort C: DRV/RTV + FTC/TDF
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments Inference was assessed against a type I error of 2.5% to account for multiple comparisons.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change
Estimated Value 0.24
Confidence Interval (2-Sided) 97.5%
-0.63 to 1.11
Estimation Comments The difference in change in relative FMD (Cohort A: ATV/RTV+FTC/TDF - Cohort C: DRV/RTV+FTC/TDF); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: ATV/RTV + FTC/TDF, Cohort B: RAL + FTC/TDF, Cohort C: DRV/RTV + FTC/TDF
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments Inference was assessed against a type I error of 2.5% to account for multiple comparisons.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Change (%)
Estimated Value -0.21
Confidence Interval (2-Sided) 97.5%
-0.98 to 0.55
Estimation Comments The difference in change in relative FMD (Cohort B - Cohort A and C); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.
3.Secondary Outcome
Title Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 103 102 107
Mean (95% Confidence Interval)
Unit of Measure: percent
Change from study entry to week 4
-0.04
(-0.54 to 0.46)
0.22
(-0.36 to 0.81)
-0.15
(-0.65 to 0.34)
Change from study entry to week 48
-0.04
(-0.60 to 0.52)
-0.08
(-0.73 to 0.58)
-0.11
(-0.71 to 0.49)
4.Secondary Outcome
Title Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 103 102 107
Mean (Standard Deviation)
Unit of Measure: mm
Change from study entry to week 4 0.002  (0.100) 0.012  (0.105) -0.005  (0.102)
Change from study entry to week 24 -0.002  (0.103) -0.004  (0.101) 0.008  (0.116)
Change from study entry to week 48 0.002  (0.111) 0.005  (0.120) -0.001  (0.119)
5.Secondary Outcome
Title Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 98 94 96
Median (Inter-Quartile Range)
Unit of Measure: percent
-3.7
(-5.7 to -1.4)
-2.2
(-4.5 to 0.4)
-3.3
(-5.2 to -0.9)
6.Secondary Outcome
Title Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 99 94 96
Median (Inter-Quartile Range)
Unit of Measure: percent
-4.0
(-6.5 to -0.3)
-1.6
(-3.6 to 0.9)
-3.1
(-5.2 to -0.8)
7.Secondary Outcome
Title Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 98 94 97
Median (Inter-Quartile Range)
Unit of Measure: percent
-1.9
(-3.7 to -1.0)
-0.9
(-2.7 to 0.6)
-1.0
(-2.3 to 0.5)
8.Secondary Outcome
Title Percent Change in Total Limb Fat From Study Entry to Week 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 98 94 97
Median (Inter-Quartile Range)
Unit of Measure: percent
9.8
(-3.7 to 21.3)
6.3
(-7.5 to 27.7)
7.9
(-5.8 to 22.9)
9.Secondary Outcome
Title Percent Change in Trunk Fat From Study Entry to Week 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 98 94 97
Median (Inter-Quartile Range)
Unit of Measure: percent
10.8
(-3.4 to 27.7)
13.5
(-5.3 to 38.3)
9.7
(-3.7 to 33.6)
10.Secondary Outcome
Title Percent Change in Lean Mass From Study Entry to Week 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 98 94 97
Median (Inter-Quartile Range)
Unit of Measure: percent
1.8
(-1.2 to 4.7)
1.7
(-1.8 to 5.0)
0.1
(-2.1 to 2.8)
11.Secondary Outcome
Title Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 97 95 94
Median (Inter-Quartile Range)
Unit of Measure: percent
10.7
(-12.0 to 50.2)
16.2
(-7.9 to 43.3)
9.5
(-8.7 to 37.8)
12.Secondary Outcome
Title Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 97 95 94
Median (Inter-Quartile Range)
Unit of Measure: percent
10.3
(-5.9 to 26.5)
11.8
(-6.5 to 36.1)
11.4
(-7.9 to 33.4)
13.Secondary Outcome
Title CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 109 106 113
Median (Inter-Quartile Range)
Unit of Measure: cell/mm^3
Study Entry
350
(211 to 461)
343
(185 to 445)
355
(207 to 461)
Week 24
509
(356 to 653)
445
(348 to 610)
464
(299 to 592)
Week 48
573
(414 to 716)
496
(367 to 689)
528
(355 to 627)
Week 96
634
(452 to 768)
569
(416 to 717)
567
(417 to 749)
Week 144
658
(478 to 834)
613
(437 to 801)
560
(431 to 756)
14.Secondary Outcome
Title Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 107 99 108
Median (Inter-Quartile Range)
Unit of Measure: cell/mm^3
Change from study entry to week 24
161
(91 to 252)
133
(63 to 216)
118
(33 to 203)
Change from study entry to week 48
209
(138 to 319)
191
(89 to 311)
194
(76 to 276)
Change from study entry to week 96
280
(180 to 390)
247
(107 to 343)
248
(124 to 341)
Change from study entry to week 144
305
(209 to 426)
279
(142 to 400)
227
(115 to 391)
15.Secondary Outcome
Title Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 109 105 112
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Change from study entry to week 4
4
(-11 to 19)
-7
(-25 to 9)
3
(-13 to 21)
Change from study entry to week 24
9
(-8 to 24)
-4
(-23 to 14)
7
(-6 to 33)
Change from study entry to week 48
8
(-8 to 26)
-1
(-24 to 24)
12
(-7 to 31)
Change from study entry to week 96
12
(-6 to 32)
1
(-16 to 23)
14
(-8 to 38)
16.Secondary Outcome
Title Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 109 105 112
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Change from study entry to week 4
14
(-19 to 50)
-12
(-41 to 11)
15
(-7 to 43)
Change from study entry to week 24
6
(-20 to 39)
-16
(-48 to 4)
2
(-19 to 46)
Change from study entry to week 48
9
(-22 to 50)
-13
(-40 to 13)
8
(-18 to 41)
Change from study entry to week 96
10
(-29 to 45)
-7
(-28 to 19)
0
(-27 to 28)
17.Secondary Outcome
Title Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 109 105 112
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Change from study entry to week 4
-1
(-6 to 6)
-2
(-6 to 4)
-3
(-7 to 2)
Change from study entry to week 24
3
(-3 to 10)
3
(-4 to 7)
0
(-5 to 9)
Change from study entry to week 48
2
(-5 to 10)
2
(-3 to 10)
1
(-3 to 6)
Change from study entry to week 96
4
(-3 to 10)
4
(-2 to 10)
4
(-3 to 9)
18.Secondary Outcome
Title Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 108 104 110
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Change from study entry to week 4
0
(-12 to 11)
-3
(-17 to 10)
1
(-6 to 17)
Change from study entry to week 24
2
(-15 to 16)
-2
(-16 to 14)
3
(-8 to 24)
Change from study entry to week 48
1
(-12 to 17)
-1
(-16 to 21)
5
(-8 to 19)
Change from study entry to week 96
2
(-11 to 20)
-1
(-15 to 18)
6
(-8 to 31)
19.Secondary Outcome
Title Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 109 105 112
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Change from study entry to week 4
3
(-2 to 8)
3
(-2 to 8)
2
(-3 to 7)
Change from study entry to week 24
4
(-1 to 8)
4
(0 to 10)
4
(-3 to 8)
Change from study entry to week 48
4
(-2 to 14)
4
(-2 to 10)
2
(-5 to 7)
Change from study entry to week 96
3
(-2 to 10)
6
(2 to 13)
2
(-2 to 8)
20.Secondary Outcome
Title Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 109 105 112
Median (Inter-Quartile Range)
Unit of Measure: uIU/dL
Change from study entry to week 4
4.0
(1.0 to 8.0)
3.0
(0.0 to 6.0)
3.0
(0.0 to 5.0)
Change from study entry to week 24
4.0
(1.0 to 8.0)
3.0
(1.0 to 5.0)
2.0
(0.0 to 6.0)
Change from study entry to week 48
4.0
(0.0 to 9.0)
3.0
(0.0 to 7.0)
3.0
(0.0 to 5.0)
Change from study entry to week 96
3.5
(0.0 to 8.0)
3.0
(0.0 to 6.0)
2.0
(0.0 to 6.0)
21.Secondary Outcome
Title Fold Change in D-dimer From Study Entry to Weeks 48 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 108 105 110
Median (Inter-Quartile Range)
Unit of Measure: Fold change
Fold change from study entry to week 48
0.57
(0.31 to 1.00)
0.73
(0.40 to 1.43)
0.65
(0.35 to 1.00)
Fold change from study entry to week 96
0.52
(0.26 to 1.00)
0.72
(0.44 to 1.15)
0.65
(0.29 to 1.53)
22.Secondary Outcome
Title Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 109 106 109
Median (Inter-Quartile Range)
Unit of Measure: Fold change
Fold change from study entry to week 48
0.75
(0.44 to 1.54)
0.88
(0.40 to 1.75)
0.78
(0.32 to 1.54)
Fold change from study entry to week 96
0.85
(0.45 to 1.64)
0.78
(0.32 to 1.54)
1.31
(0.65 to 2.60)
23.Secondary Outcome
Title Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 109 106 109
Median (Inter-Quartile Range)
Unit of Measure: Fold change
Fold change from study entry to week 48
0.62
(0.39 to 1.16)
0.71
(0.51 to 1.23)
0.75
(0.46 to 1.37)
Fold change from study entry to week 96
0.89
(0.56 to 1.45)
0.82
(0.51 to 1.34)
0.89
(0.58 to 1.65)
24.Secondary Outcome
Title Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 108 106 108
Median (Inter-Quartile Range)
Unit of Measure: Fold change
Fold change from study entry to week 48
1.01
(0.90 to 1.14)
0.91
(0.78 to 1.07)
1.00
(0.83 to 1.13)
Fold change from study entry to week 96
0.98
(0.83 to 1.18)
0.90
(0.76 to 1.02)
0.98
(0.79 to 1.17)
25.Secondary Outcome
Title Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 104 101 102
Median (Inter-Quartile Range)
Unit of Measure: Fold change
Fold change from study entry to week 48
0.54
(0.44 to 0.71)
0.62
(0.48 to 0.78)
0.61
(0.49 to 0.78)
Fold change from study entry to week 96
0.51
(0.40 to 0.66)
0.56
(0.43 to 0.72)
0.58
(0.44 to 0.80)
26.Secondary Outcome
Title Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 101 95 101
Median (Inter-Quartile Range)
Unit of Measure: Fold change
Fold change from study entry to week 24
0.49
(0.35 to 0.70)
0.51
(0.37 to 0.68)
0.52
(0.40 to 0.79)
Fold change from study entry to week 96
0.38
(0.24 to 0.55)
0.34
(0.23 to 0.54)
0.37
(0.25 to 0.56)
27.Secondary Outcome
Title Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description:

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)

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)

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)

Overall Number of Participants Analyzed 101 95 101
Median (Inter-Quartile Range)
Unit of Measure: Fold change
Fold change from study entry to week 24
0.51
(0.39 to 0.63)
0.56
(0.46 to 0.71)
0.59
(0.39 to 0.74)
Fold change from study entry to week 96
0.35
(0.27 to 0.50)
0.36
(0.24 to 0.46)
0.38
(0.22 to 0.56)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not collected in this study. Please refer to the ACTG A5257 study (NCT00811954) ClinicalTrials.gov records for all adverse event summaries.
 
Arm/Group Title Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Hide Arm/Group Description

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)

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)

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)

All-Cause Mortality
Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort A: ATV/RTV + FTC/TDF Cohort B: RAL + FTC/TDF Cohort C: DRV/RTV + FTC/TDF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Publications of Results:
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00851799     History of Changes
Other Study ID Numbers: ACTG A5260s
1U01AI068636 ( U.S. NIH Grant/Contract )
ACTG A5257 metabolic substudy
First Submitted: February 24, 2009
First Posted: February 26, 2009
Results First Submitted: November 4, 2015
Results First Posted: January 13, 2016
Last Update Posted: January 13, 2016