Trial Outcomes & Findings for Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir (NCT NCT00458302)

NCT ID: NCT00458302

Last Updated: 2012-12-19

Results Overview

Virological response is defined as the number of patients in the PP population with a plasma viral load \< 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure\* (referred to as a Switch Equals Failure analysis). \*Discontinuations and rechallenge with NRTIs are taken into account until Week 48

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 256 participants
• Primary outcome timeframe: Week 48
• Results posted on: 2012-12-19

Participant Flow

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Participant milestones

Measure	DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Overall Study STARTED	129	127
Overall Study COMPLETED	109	103
Overall Study NOT COMPLETED	20	24

Reasons for withdrawal

Measure	DRV/r+2NRTIs 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Overall Study Adverse Event	4	14
Overall Study Pregnancy	2	1
Overall Study Protocol Violation	0	2
Overall Study Withdrawal by Subject	6	4
Overall Study Inc/Exc Criteria Not Met	1	1
Overall Study Study Termination By Sponsor	1	0
Overall Study Lost to Follow-up	2	0
Overall Study Other	4	2

Baseline Characteristics

Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir

Baseline characteristics by cohort

Measure	DRV/r+2NRTIs n=129 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=127 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks	Total n=256 Participants Total of all reporting groups
Region of Enrollment RUSSIAN FEDERATION	9 participants n=5 Participants	2 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment SPAIN	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants
Region of Enrollment SWITZERLAND	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment UNITED KINGDOM	12 participants n=5 Participants	9 participants n=7 Participants	21 participants n=5 Participants
plasma viral load < 50	125 participants n=5 Participants	118 participants n=7 Participants	243 participants n=5 Participants
plasma viral load 50-400	4 participants n=5 Participants	7 participants n=7 Participants	11 participants n=5 Participants
plasma viral load 400-1000	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
plasma viral load > 1000	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
CD4+ cell count (absolute count)	579.0 cells/µl n=5 Participants	571.0 cells/µl n=7 Participants	573.5 cells/µl n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	128 Participants n=5 Participants	125 Participants n=7 Participants	253 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age Continuous	44.1 years STANDARD_DEVIATION 9.74 • n=5 Participants	43.4 years STANDARD_DEVIATION 9.14 • n=7 Participants	43.7 years STANDARD_DEVIATION 9.43 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	28 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	99 Participants n=7 Participants	206 Participants n=5 Participants
Region of Enrollment AUSTRIA	9 participants n=5 Participants	7 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment BELGIUM	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Region of Enrollment DENMARK	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants
Region of Enrollment GERMANY	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants
Region of Enrollment HUNGARY	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment ISRAEL	1 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment ITALY	11 participants n=5 Participants	5 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment POLAND	9 participants n=5 Participants	20 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment PORTUGAL	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: PP population: all randomised patients who took study drug, and who did not deviate from the protocol.This excludes 10 patients with major protocol deviations.

Virological response is defined as the number of patients in the PP population with a plasma viral load < 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 48

Outcome measures

Measure	DRV/r+2NRTIs n=123 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=123 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]	108 participants	106 participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.

Virological response is defined as the number of patients in the ITT population with a plasma viral load < 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until start of Week 48 window

Outcome measures

Measure	DRV/r+2NRTIs n=129 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=127 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]	110 participants	107 participants

SECONDARY outcome

Timeframe: Week 144

Population: PP population: all randomised subjects who took study drug, and who did not deviate from the protocol.This excludes 13 subjects with major protocol deviations.

Virological response is defined as the number of patients in the PP population with a plasma viral load < 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144

Outcome measures

Measure	DRV/r+2NRTIs n=121 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=122 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]	94 participants	88 participants

SECONDARY outcome

Timeframe: Week 144

Population: ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.

Virological response is defined as the number of patients in the ITT population with a plasma viral load < 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). All switches included means that all data even after any changes of treatment were kept. *Discontinuations and rechallenge with NRTIs are taken into account until start of Week 144 window.

Outcome measures

Measure	DRV/r+2NRTIs n=129 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=127 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144]	106 participants	106 participants

SECONDARY outcome

Timeframe: week 144

Population: PP population: all randomised patients who took study drug, and who did not deviate from the protocol. This excludes 13 patients with major protocol deviations.

Virological response is defined as the number of patients in the PP population with a plasma viral load < 200 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144

Outcome measures

Measure	DRV/r+2NRTIs n=121 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=122 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]	102 Participants	95 Participants

SECONDARY outcome

Timeframe: at week 4, 12, 24, 36, 48, 60, 72, 84, 96, 112, 128, 144

Population: ITT: all randomized patients who had at least 1 dose of study medication, regardless of their adherence to the protocol

The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.

Outcome measures

Measure	DRV/r+2NRTIs n=129 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=127 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Mean Change From Baseline in CD4+ Cell Count week 4	-16.9 number of cells/L (x10^6) Standard Error 15.7	-32.9 number of cells/L (x10^6) Standard Error 14.6
Mean Change From Baseline in CD4+ Cell Count week 12	-23.6 number of cells/L (x10^6) Standard Error 14.7	-20.7 number of cells/L (x10^6) Standard Error 15.2
Mean Change From Baseline in CD4+ Cell Count week 24	-5.4 number of cells/L (x10^6) Standard Error 14.6	-35.8 number of cells/L (x10^6) Standard Error 14.2
Mean Change From Baseline in CD4+ Cell Count week 36	-1.2 number of cells/L (x10^6) Standard Error 15.8	-21.1 number of cells/L (x10^6) Standard Error 14.3
Mean Change From Baseline in CD4+ Cell Count week 48	-19.0 number of cells/L (x10^6) Standard Error 14.7	-15.1 number of cells/L (x10^6) Standard Error 16.0
Mean Change From Baseline in CD4+ Cell Count week 60	-4.0 number of cells/L (x10^6) Standard Error 14.9	-2.3 number of cells/L (x10^6) Standard Error 14.4
Mean Change From Baseline in CD4+ Cell Count week 72	24.1 number of cells/L (x10^6) Standard Error 16.1	-12.3 number of cells/L (x10^6) Standard Error 14.3
Mean Change From Baseline in CD4+ Cell Count week 84	34.6 number of cells/L (x10^6) Standard Error 17.2	-3.7 number of cells/L (x10^6) Standard Error 15.0
Mean Change From Baseline in CD4+ Cell Count week 96	49.1 number of cells/L (x10^6) Standard Error 15.9	54.8 number of cells/L (x10^6) Standard Error 16.2
Mean Change From Baseline in CD4+ Cell Count week 112	106.0 number of cells/L (x10^6) Standard Error 16.7	87.5 number of cells/L (x10^6) Standard Error 16.2
Mean Change From Baseline in CD4+ Cell Count week 128	117.3 number of cells/L (x10^6) Standard Error 18.3	90.4 number of cells/L (x10^6) Standard Error 14.9
Mean Change From Baseline in CD4+ Cell Count week 144	99.3 number of cells/L (x10^6) Standard Error 15.7	94.9 number of cells/L (x10^6) Standard Error 15.0

SECONDARY outcome

Timeframe: at each visit from baseline to week 144

Population: ITT: all randomised patients who had at least 1 dose of study medication, regardless of their adherence to the protocol.

Number of patients with resistance mutations at any time point when a patient had a viral load > 50 copies/mL after randomization.

Outcome measures

Measure	DRV/r+2NRTIs n=129 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=127 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Resistance Determinations >= 1 HIV-1 RNA > 50 copies/mL	42 number of participants	48 number of participants
Resistance Determinations >= 1 successful genotype after baseline	23 number of participants	31 number of participants
Resistance Determinations >= 1 IAS-USA primary PI mutations	1 number of participants	1 number of participants
Resistance Determinations >= 1 DRV RAMs	0 number of participants	1 number of participants
Resistance Determinations NRTI RAMs	1 number of participants	0 number of participants
Resistance Determinations M184V mutation	1 number of participants	0 number of participants
Resistance Determinations no primary PI, DRV, NRTI or M184 V mutations	22 number of participants	30 number of participants

SECONDARY outcome

Timeframe: at baseline, week 48, 96 and 144

Population: ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

The FAHI is a validated health-related quality of life questionnaire. The questionnaire consist of 44 items and includes 5 functional scales (physical, social, emotional, functional and global well-being and cognitive function). Each item is assessing the impact of HIV on a scale from 0 (not at all) to 5 (very much).

Outcome measures

Measure	DRV/r+2NRTIs n=126 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=112 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score week 48	1.7 points on a scale Standard Error 1.7	1.7 points on a scale Standard Error 2.0
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score week 96	0.4 points on a scale Standard Error 1.6	3.5 points on a scale Standard Error 2.4
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score week 144	0.7 points on a scale Standard Error 1.7	3.1 points on a scale Standard Error 2.4

SECONDARY outcome

Timeframe: at baseline, week 48, 96 and 144

Population: ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

The FAHI cognitive function subscale. Each item is assessing the impact of HIV on cognitive function on a scale from 0 (not at all) to 5 (very much).

Outcome measures

Measure	DRV/r+2NRTIs n=127 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=115 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale week 48	0.1 points on a scale Standard Error 0.2	-0.1 points on a scale Standard Error 0.2
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale week 96	-0.1 points on a scale Standard Error 0.2	-0.1 points on a scale Standard Error 0.2
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale week 144	0.1 points on a scale Standard Error 0.2	-0.1 points on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: at baseline, week 48, 96 and 144

Population: ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

The FAHI emotional well-being subscale. Each item is assessing the impact of HIV on emotional well-being on a scale from 0 (not at all) to 5 (very much).

Outcome measures

Measure	DRV/r+2NRTIs n=128 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=118 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale week 48	0.1 points on a scale Standard Error 0.6	1.8 points on a scale Standard Error 0.7
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale week 96	1.0 points on a scale Standard Error 0.5	1.3 points on a scale Standard Error 0.7
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale week 144	1.4 points on a scale Standard Error 0.5	1.7 points on a scale Standard Error 0.7

SECONDARY outcome

Timeframe: at baseline, week 48, 96 and 144

Population: ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

The FAHI functional and global well-being subscale. Each item is assessing the impact of HIV on functional and global well-being on a scale from 0 (not at all) to 5 (very much).

Outcome measures

Measure	DRV/r+2NRTIs n=127 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=116 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale week 48	0.3 points on a scale Standard Error 0.8	-0.8 points on a scale Standard Error 0.7
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale week 96	-0.1 points on a scale Standard Error 0.7	0.4 points on a scale Standard Error 0.9
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale week 144	-0.6 points on a scale Standard Error 0.8	0.0 points on a scale Standard Error 1.0

SECONDARY outcome

Timeframe: at baseline, week 48, 96 and 144

Population: ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

The FAHI physical well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).

Outcome measures

Measure	DRV/r+2NRTIs n=128 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=118 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale week 48	0.6 points on a scale Standard Error 0.5	1.0 points on a scale Standard Error 0.8
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale week 96	0.4 points on a scale Standard Error 0.5	1.4 points on a scale Standard Error 0.9
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale week 144	0.0 points on a scale Standard Error 0.5	1.0 points on a scale Standard Error 0.8

SECONDARY outcome

Timeframe: at baseline, week 48, 96 and 144

Population: ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.

The FAHI social well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).

Outcome measures

Measure	DRV/r+2NRTIs n=126 Participants 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=115 Participants 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale week 48	0.4 points on a scale Standard Error 0.5	-0.2 points on a scale Standard Error 0.5
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale week 96	-0.6 points on a scale Standard Error 0.5	0.8 points on a scale Standard Error 0.6
Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale week 144	-0.3 points on a scale Standard Error 0.5	0.6 points on a scale Standard Error 0.6

Adverse Events

DRV/r+2NRTIs

Serious events: 14 serious events

Other events: 98 other events

Deaths: 0 deaths

DRV/r

Serious events: 14 serious events

Other events: 103 other events

Deaths: 0 deaths

Total

Serious events: 28 serious events

Other events: 201 other events

Deaths: 0 deaths

Serious adverse events

Measure	DRV/r+2NRTIs n=129 participants at risk 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=127 participants at risk 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks	Total n=256 participants at risk
Infections and infestations Gastroenteritis	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Infections and infestations Hepatitis A	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Infections and infestations Pneumonia	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Infections and infestations Respiratory Tract Infection	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Infections and infestations Subcutaneous Abscess	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Infections and infestations Bronchitis	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Infections and infestations Hepatitis C	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Infections and infestations Neurosyphilis	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	1.6% 2/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.78% 2/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Infections and infestations Secondary Syphilis	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Blood and lymphatic system disorders Anaemia	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Blood and lymphatic system disorders Thrombocytopenia	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's Disease	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue Neoplasm Malignant Stage Unspecified	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Nervous system disorders Convulsion	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Nervous system disorders Nervous System Disorder	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Cardiac disorders Acute Myocardial Infarction	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Gastrointestinal disorders Duodenal Ulcer	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Gastrointestinal disorders Dysphagia	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Gastrointestinal disorders Vomiting	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
General disorders Pyrexia	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.78% 2/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Investigations Aspartate Aminotransferase Increased	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Investigations Csf Pressure Decreased	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Investigations Lipase Increased	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Psychiatric disorders Somatoform Disorder	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Psychiatric disorders Psychotic Disorder	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	1.6% 2/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.78% 2/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Renal and urinary disorders Nephrolithiasis	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Surgical and medical procedures Cataract Operation	0.78% 1/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.00% 0/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Surgical and medical procedures Varicose Vein Operation	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Eye disorders Uveitis	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Hepatobiliary disorders Jaundice	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Injury, poisoning and procedural complications Incisional Hernia	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.39% 1/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.

Other adverse events

Measure	DRV/r+2NRTIs n=129 participants at risk 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks	DRV/r n=127 participants at risk 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks	Total n=256 participants at risk
Gastrointestinal disorders Diarrhoea	20.2% 26/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	20.5% 26/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	20.3% 52/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Gastrointestinal disorders Vomiting	7.0% 9/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	3.9% 10/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Gastrointestinal disorders Nausea	5.4% 7/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	3.9% 5/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	4.7% 12/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Infections and infestations Bronchitis	9.3% 12/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	7.9% 10/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	8.6% 22/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Infections and infestations Nasopharyngitis	7.8% 10/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	11.8% 15/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	9.8% 25/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Infections and infestations Respiratory Tract Infection	7.0% 9/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	0.79% 1/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	3.9% 10/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Infections and infestations Upper Respiratory Tract Infection	5.4% 7/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	9.4% 12/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	7.4% 19/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Renal and urinary disorders Haematuria	9.3% 12/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	5.5% 7/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	7.4% 19/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Renal and urinary disorders Leukocyturia	5.4% 7/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	4.7% 6/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	5.1% 13/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Nervous system disorders Headache	7.8% 10/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	9.4% 12/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	8.6% 22/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Vascular disorders Hypertension	7.0% 9/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	4.7% 6/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	5.9% 15/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 8/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	5.5% 7/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	5.9% 15/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Psychiatric disorders Depression	5.4% 7/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	9.4% 12/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	7.4% 19/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
General disorders Fatigue	4.7% 6/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	5.5% 7/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	5.1% 13/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Metabolism and nutrition disorders Hypercholesterolaemia	4.7% 6/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	15.0% 19/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	9.8% 25/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Musculoskeletal and connective tissue disorders Back Pain	3.1% 4/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	6.3% 8/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	4.7% 12/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Skin and subcutaneous tissue disorders Rash	3.1% 4/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	6.3% 8/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	4.7% 12/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.
Investigations Blood Cholesterol Increased	1.6% 2/129 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	5.5% 7/127 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.	3.5% 9/256 • Adverse events were collected for the duration of the study. Mean exposure at the time of primary analysis (Week 48) was 457.3 days for the overall study population (462.3 days for the DRV/r+2NRTIs group and 452.2 days for the DRV/r group). Adverse events were either reported by the subjects voluntarily or were obtained by means of interviewing subjects in a non-directed manner at study visits.

Additional Information

EMEA Medical Affairs Director Virology

Jan-Cilag Germany

Phone: +49 7624 907580

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor (SP) shall have the 1st right to present the Data without approval from the Principal Investigator (PI). If no publication is submitted by SP within 12 months after closure, or after SP confirms there will be no publication, the PI shall have the right to publish. Prior to submission, the PI will provide the SP with at least 45 days for review of a manuscript. If requested, the PI will withhold such publication for up to an additional 60 days to allow for filing of a patent application
• Publication restrictions are in place

Restriction type: OTHER