Comparative Study of Three NNRTI-Sparing HAART Regimens

The ARDENT Study: Atazanavir, Raltegravir, or Darunavir With Emtricitabine/Tenofovir for Naive Treatment

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00811954

Enrollment

1814

Registered

2008-12-19

Start date

2009-05-31

Completion date

2013-06-30

Last updated

2014-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

Treatment naive, Treatment inexperienced

Brief summary

The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected patients who have never received anti-HIV therapy be treated with a triple drug regimen. The most commonly prescribed and successful regimen contains the medication efavirenz (EFV). However, this regimen may not be an option for everyone, hence alternative regimens are needed. This study was designed to look at how well different combinations of anti-HIV drugs work to decrease the amount of HIV in the blood (viral load) of and allow immune system recovery in people who have never received anti-HIV therapy. This study also examined drug tolerability and safety for the various drug combinations.

Detailed description

Of the five anti-HIV drug classes, four were recommended as first-line regimens for patients who have never received anti-HIV treatment before (treatment naive): nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), Integrase Inhibitors (INIs) and protease inhibitors (PIs). The U.S. Department of Health and Human Services (HHS) guidelines recommend that treatment-naive HIV infected patients be treated with a triple drug regimen that includes 2 NRTIs + 1 NNRTI, 2 NRTIs + INI, or 2 NRTIs + 1 PI as their initial treatment regimen. According to data, an efavirenz (EFV)-containing regimen (2 NRTIs + 1 NNRTI, with EFVas the NNRTI) requires fewer pills for the patient, has mild and few side effects, and is more effective in reducing viral load than other regimens, making it the preferred choice for most patients. However, for some patients, an EFV-containing regimen is not feasible due to side effects, acquired NNRTI-resistant HIV virus, or other undesirable effects. For these patients, it is necessary to find alternative regimens with comparable safety and efficacy. This study examined how well different combinations of anti-HIV drugs work, including safety and drug tolerability for various combinations. This was a phase III, prospective, randomized study. Participants was randomly assigned to one of three different groups (treatment arms)-A, B, or C -each representing a different drug combination regimen, none of which contained an NNRTI. Arm A: Atazanavir (ATV) + Ritonavir (RTV) + Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) Arm B: Raltegravir (RAL) + FTC/TDF Arm C: Darunavir (DRV) + RTV + FTC/TDF The duration of this study was between 96 and 192 weeks, depending on when the participant enrolled. There were a total of 1,809 participants, approximately 600 per treatment arm. Screening and pre-entry evaluations must occur prior to the participant starting any study medication, treatments, or interventions. Participants were randomly assigned to their treatment groups at the entry visit and must begin treatment within 72 hours of randomization. Participants was told which group they were in and what medications they were administered. The study drugs were distributed at entry. All drugs were provided by the study with the exception of RTV, which would have to be obtained through the participant's primary care physician (Group A or C). If a participant was unable to tolerate any of the study medications during the course of the study then their doctor could switch them to another regimen. During the study, participants was asked to return to the clinic at Weeks 4, 8, 16, 24, 36, and 48 and then every 16 weeks until the end of the study. They were also contacted by telephone during Week 2 to check on their status. Visits were last about 1 hour. At most visits, participants had a physical exam and answered questions about any medications they were taken. Additionally, participants completed questionnaires addressing their smoking and alcohol habits, had blood drawn, and were asked to give urine samples. At some visits, participants had to come to the clinic without having eaten for 8 hours. If the participant was female and able to become pregnant, a pregnancy test might be given at any visit if pregnancy was suspected. Some participants of A5257 were asked to participate in an optional metabolic substudy A5260s. This substudy took place at only some study sites and continued last up to 144 weeks, including time on A5257. The primary focus of this substudy was to examine carotid artery intima-media thickness (CIMT) as it relates to both RTV- and RAL-containing regimens. Randomization, stratification, treatment assignments, and study visits were as per A5257.

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).

DRUGRaltegravir

400 mg taken orally twice daily. An integrase inhibitor (INI).

DRUGDarunavir

800 mg taken orally once daily. A protease inhibitor (PI).

DRUGRitonavir

100 mg taken orally once daily. A protease inhibitor (PI).

DRUGAtazanavir

300 mg taken orally once daily. A protease inhibitor (PI).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* HIV-1 infected * No evidence of any exclusionary mutations defined as any major NRTI or PI resistance-associated mutation on any genotype or evidence of significant NRTI or PI resistance on any phenotype performed at any time prior to study entry. NNRTI-associated resistance mutations are not excluded. More information on this criterion can be found in the study protocol. * No prior anti-HIV therapy. More information on this criterion can be found in the study protocol. * Viral load is 1000 copies/mL or higher, as measured within 90 days prior to study entry * Certain laboratory values obtained within 60 days prior to study entry * Ability to obtain RTV by prescription * Completed cardiovascular risk assessment. More information on this criterion can be found in the study protocol. * Must agree to use acceptable forms of contraception while receiving study drugs and for 6 weeks after stopping the medications. More information on this criterion is available in the protocol. * Negative pregnancy test within 72 hours before initiating antiretroviral medication * Participating in research at any AIDS Clinical Trial Group (ACTG) clinical research site or select International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) group sites * Ability and willingness of subject or legal guardian/representative to give written informed consent

Exclusion criteria

* Use of immunomodulators, HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Those using stable physiologic glucocorticoid doses, a short course of pharmacologic glucocorticoid, corticosteroids for acute therapy treating an opportunistic infection, inhaled or topical corticosteroids, or granulocyte-colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) will not be excluded. * Known allergy or sensitivity to study drugs or their ingredients. A history of sulfa allergy is not excluded. * Any condition that, in the opinion of the investigator, would compromise the participant's ability to participate in the study * Serious illness requiring systemic treatment and/or hospitalization until participant either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 7 days prior to study entry * Requirement for any current medications that are prohibited with any study drugs * Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness * Any prior use of entecavir for treatment of hepatitis B for greater than 8 weeks while the participant was known to be HIV infected * Presence of decompensated cirrhosis * Pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame	Description
Cumulative Probability of First Virologic Failure by Week 96	From study entry to week 96	The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96. Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA \>1000 copies/mL at or after week 16 and before week 24, or \>200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry.
Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96	From study entry to week 96	The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date.

Secondary

Measure	Time frame	Description
Presence of Mutations Associated With NRTI Resistance	At the virologic failure at any time throughout the study (up to 213 weeks)	The number of participants with NRTI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.
Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance	At the virologic failure at any time throughout the study (up to 213 weeks)	The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.
Presence of Mutations Associated With INI Resistance	At the virologic failure at any time throughout the study (up to 213 weeks)	The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.
CD4+ T-cell Count	At Weeks 24, 48, 96, and 144	The absolute levels of CD4+ T-cell counts (cells/mm3)
CD4+ T-cell Count Changes From Baseline	Study entry to weeks 24, 48, 96, and 144	Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count
Incidence of Death or AIDS Defining Events (CDC Category C)	Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable	The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.
Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD)	Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable	The incidence of targeted serious non-AIDS defining events was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.
Cumulative Incidence of First Adverse Event by Week 96	From study entry to week 96	The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event. The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade \>3 after week 48, and laboratory values grade \>3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up.
Change in Fasting HDL Cholesterol Level From Baseline	Study entry to weeks 48, 96, and 144	Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol.
Change in Fasting Triglycerides Level From Baseline	Study entry to weeks 48, 96, and 144	Only fasting results are included. Change was calculated as the fasting triglycerides at week (48, 96, and 144) minus the baseline fasting triglycerides.
Change in Fasting Plasma Glucose Level From Baseline	Study entry to weeks 48, 96, and 144	Only fasting results are included. Change was calculated as the fasting plasma glucose at week (48, 96, and 144) minus the baseline fasting plasma glucose.
Change in Framingham 10-year Risk of MI or Coronary Death From Baseline	Study entry to weeks 48, 96, and 144	Only risk score estimated with fasting lipid results were included. Change was calculated as the Framingham 10-year risk of MI or coronary death at week (48, 96, and 144) minus the baseline Framingham 10-year risk of MI or coronary death. Framingham 10-year risk of MI or coronary death was calculated using Hear Coronary Heart Disease (10-year risk) found at https://www.framinghamheartstudy.org/risk-functions/coronary-heart-disease/hard-10-year-risk.php. Framingham 10-year risk of MI or coronary death was calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, systolic blood pressure, and treatment for hypertension. The Framingham 10-year risk of MI or coronary death was calculated as: for males: \<0 point (\<1 percent risk) up to ≥17 points (≥30 percent risk); whereas for females: \<9 points (\<1 percent risk) up to ≥25 points (≥30 percent risk). Higher scores indicate high cardiovascular risk.
Change in Waist Circumference From Baseline	Study entry to weeks 48, 96, and 144	Change was calculated as the waist circumference (based on mid-waist circumference) at week (48, 96, and 144) minus the baseline waist circumference.
Change in Waist:Height Ratio From Baseline	Study entry to weeks 48, 96, and 144	Change was calculated as the waist:height ratio at week (48, 96, and 144) minus the baseline waist:height ratio.
Self-reported Adherence	At Weeks 4, 24, 48, 96, and 144	Self-reported percentage of anti-HIV medications participant had taken during the last month at weeks 4, 24, 48, 96, and 144.
Change in Fasting Total Cholesterol Level From Baseline	Study entry to weeks 48, 96, and 144	Only fasting results are included. Change was calculated as the fasting total cholesterol at week (48, 96, and 144) minus the baseline fasting total cholesterol.
Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96	From study entry to week 96	The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96. A composite TLOVR endpoint defined in the CDER of the FDA document Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf. If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels \>200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit.

Countries

Puerto Rico, United States

Participant flow

Recruitment details

Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between May 22, 2009 (date first subject was randomized) and June 9, 2011 (date last subject was randomized).

Pre-assignment details

1814 were randomized 1:1:1 to treatment arms A, B, and C. Results reported for 1809 eligible participants; 5 were subsequently found ineligible and excluded from all analyses.

Participants by arm

Arm	Count
Arm A: 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)	605
Arm B: 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)	603
Arm C: 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)	601
Total	1,809

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Complete Protocol: No follow-up	0	0	1
Overall Study	Death	10	6	13
Overall Study	Lost to Follow-up	29	23	34
Overall Study	Not able to get to clinic	28	35	30
Overall Study	Not willing to adhere to requirements	12	2	16
Overall Study	Severe Debilitation	2	0	1
Overall Study	Site Closure	4	0	1
Overall Study	Withdraw consent prior study completion	4	6	5

Baseline characteristics

Characteristic	Arm A: ATV/RTV + FTC/TDF	Arm B: RAL + FTC/TDF	Arm C: DRV/RTV + FTC/TDF	Total
Age, Categorical <=18 years	2 Participants	2 Participants	2 Participants	6 Participants
Age, Categorical >=65 years	6 Participants	3 Participants	4 Participants	13 Participants
Age, Categorical Between 18 and 65 years	597 Participants	598 Participants	595 Participants	1790 Participants
Age, Continuous	38 years STANDARD_DEVIATION 11	37 years STANDARD_DEVIATION 11	38 years STANDARD_DEVIATION 11	37 years STANDARD_DEVIATION 11
CD4+ T-cell count	309 cells/mm^3 STANDARD_DEVIATION 189	306 cells/mm^3 STANDARD_DEVIATION 199	310 cells/mm^3 STANDARD_DEVIATION 189	308 cells/mm^3 STANDARD_DEVIATION 192
HIV-1 RNA	4.6 log10 copies/mL STANDARD_DEVIATION 0.7	4.6 log10 copies/mL STANDARD_DEVIATION 0.7	4.6 log10 copies/mL STANDARD_DEVIATION 0.7	4.6 log10 copies/mL STANDARD_DEVIATION 0.7
Race/Ethnicity, Customized American Indian, Alaskan Native	2 participants	2 participants	2 participants	6 participants
Race/Ethnicity, Customized Asian, Pacific Islander	11 participants	13 participants	6 participants	30 participants
Race/Ethnicity, Customized Black Non-Hispanic	252 participants	254 participants	251 participants	757 participants
Race/Ethnicity, Customized Hispanic (Regardless of Race)	125 participants	117 participants	148 participants	390 participants
Race/Ethnicity, Customized More than one race	2 participants	3 participants	2 participants	7 participants
Race/Ethnicity, Customized Unknown/missing	1 participants	2 participants	1 participants	4 participants
Race/Ethnicity, Customized White Non-Hispanic	212 participants	212 participants	191 participants	615 participants
Sex: Female, Male Female	144 Participants	148 Participants	143 Participants	435 Participants
Sex: Female, Male Male	461 Participants	455 Participants	458 Participants	1374 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	565 / 605	516 / 603	532 / 601
serious Total, serious adverse events	139 / 605	126 / 603	125 / 601

Outcome results

Primary

Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96

The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date.

Time frame: From study entry to week 96

Population: Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.

Arm	Measure	Value (NUMBER)
Arm A: ATV/RTV + FTC/TDF	Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96	14 cumulative events per 100 persons
Arm B: RAL + FTC/TDF	Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96	1 cumulative events per 100 persons
Arm C: DRV/RTV + FTC/TDF	Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96	5 cumulative events per 100 persons

Comparison: Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.97.5% CI: [9.4, 16.1]

Comparison: Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm C and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm C - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.97.5% CI: [1.4, 5.8]

Comparison: Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm C) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm C) in 96 week probability of tolerability failure with 97.5% confidence interval.97.5% CI: [5.5, 12.9]

Primary

Cumulative Probability of First Virologic Failure by Week 96

The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96. Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA \>1000 copies/mL at or after week 16 and before week 24, or \>200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry.

Time frame: From study entry to week 96

Population: Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.

Arm	Measure	Value (NUMBER)
Arm A: ATV/RTV + FTC/TDF	Cumulative Probability of First Virologic Failure by Week 96	13 cumulative probability per 100 persons
Arm B: RAL + FTC/TDF	Cumulative Probability of First Virologic Failure by Week 96	10 cumulative probability per 100 persons
Arm C: DRV/RTV + FTC/TDF	Cumulative Probability of First Virologic Failure by Week 96	15 cumulative probability per 100 persons

Comparison: Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.97.5% CI: [-0.7, 7.4]

Comparison: Treatment comparison was made using the difference (arm C - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.97.5% CI: [1.3, 9.9]

Comparison: Treatment comparison was made using the difference (arm A - arm C) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.97.5% CI: [-6.7, 2.3]

Secondary

CD4+ T-cell Count

The absolute levels of CD4+ T-cell counts (cells/mm3)

Time frame: At Weeks 24, 48, 96, and 144

Population: Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.

Arm	Measure	Group	Value (MEAN)
Arm A: ATV/RTV + FTC/TDF	CD4+ T-cell Count	week 24 (nA=582, nB=574, nC=579)	462 cells/mm^3
Arm A: ATV/RTV + FTC/TDF	CD4+ T-cell Count	week 48 (nA=564, nB=565, nC=559)	524 cells/mm^3
Arm A: ATV/RTV + FTC/TDF	CD4+ T-cell Count	week 96 (nA=523, nB=541, nC=525)	587 cells/mm^3
Arm A: ATV/RTV + FTC/TDF	CD4+ T-cell Count	week 144 (nA=395, nB=418, nC=394)	622 cells/mm^3
Arm B: RAL + FTC/TDF	CD4+ T-cell Count	week 144 (nA=395, nB=418, nC=394)	631 cells/mm^3
Arm B: RAL + FTC/TDF	CD4+ T-cell Count	week 24 (nA=582, nB=574, nC=579)	460 cells/mm^3
Arm B: RAL + FTC/TDF	CD4+ T-cell Count	week 96 (nA=523, nB=541, nC=525)	596 cells/mm^3
Arm B: RAL + FTC/TDF	CD4+ T-cell Count	week 48 (nA=564, nB=565, nC=559)	526 cells/mm^3
Arm C: DRV/RTV + FTC/TDF	CD4+ T-cell Count	week 144 (nA=395, nB=418, nC=394)	596 cells/mm^3
Arm C: DRV/RTV + FTC/TDF	CD4+ T-cell Count	week 48 (nA=564, nB=565, nC=559)	509 cells/mm^3
Arm C: DRV/RTV + FTC/TDF	CD4+ T-cell Count	week 96 (nA=523, nB=541, nC=525)	564 cells/mm^3
Arm C: DRV/RTV + FTC/TDF	CD4+ T-cell Count	week 24 (nA=582, nB=574, nC=579)	457 cells/mm^3

Secondary

CD4+ T-cell Count Changes From Baseline

Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count

Time frame: Study entry to weeks 24, 48, 96, and 144

Arm	Measure	Group	Value (MEAN)
Arm A: ATV/RTV + FTC/TDF	CD4+ T-cell Count Changes From Baseline	week 24 (nA=582, nB=574, nC=579)	157 cells/mm^3
Arm A: ATV/RTV + FTC/TDF	CD4+ T-cell Count Changes From Baseline	week 96 (nA=523, nB=541, nC=525)	284 cells/mm^3
Arm A: ATV/RTV + FTC/TDF	CD4+ T-cell Count Changes From Baseline	week 48 (nA=564, nB=565, nC=559)	218 cells/mm^3
Arm A: ATV/RTV + FTC/TDF	CD4+ T-cell Count Changes From Baseline	week 144 (nA=395, nB=418, nC=394)	324 cells/mm^3
Arm B: RAL + FTC/TDF	CD4+ T-cell Count Changes From Baseline	week 24 (nA=582, nB=574, nC=579)	153 cells/mm^3
Arm B: RAL + FTC/TDF	CD4+ T-cell Count Changes From Baseline	week 144 (nA=395, nB=418, nC=394)	325 cells/mm^3
Arm B: RAL + FTC/TDF	CD4+ T-cell Count Changes From Baseline	week 96 (nA=523, nB=541, nC=525)	288 cells/mm^3
Arm B: RAL + FTC/TDF	CD4+ T-cell Count Changes From Baseline	week 48 (nA=564, nB=565, nC=559)	218 cells/mm^3
Arm C: DRV/RTV + FTC/TDF	CD4+ T-cell Count Changes From Baseline	week 144 (nA=395, nB=418, nC=394)	288 cells/mm^3
Arm C: DRV/RTV + FTC/TDF	CD4+ T-cell Count Changes From Baseline	week 96 (nA=523, nB=541, nC=525)	256 cells/mm^3
Arm C: DRV/RTV + FTC/TDF	CD4+ T-cell Count Changes From Baseline	week 48 (nA=564, nB=565, nC=559)	201 cells/mm^3
Arm C: DRV/RTV + FTC/TDF	CD4+ T-cell Count Changes From Baseline	week 24 (nA=582, nB=574, nC=579)	147 cells/mm^3

Secondary

Change in Fasting HDL Cholesterol Level From Baseline

Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol.