Trial Outcomes & Findings for A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN) (NCT NCT00524368)

Last Updated: 2013-02-15

Results Overview

The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

590 participants

Primary outcome timeframe

48 Weeks

Results posted on

2013-02-15

Participant Flow

One hundred thirteen investigators in 21 countries participated in this study.

In total 1092 participants were screened, of which 590 participants were randomly assigned and treated (294 participants were treated with DRV/rtv 800/100 mg once daily, and 296 participants with DRV/rtv 600/100 mg twice daily.

Participant milestones

Participant milestones
Measure	DRV/Rtv 800/100 mg Once Daily Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Study STARTED	294	296
Overall Study COMPLETED	253	248
Overall Study NOT COMPLETED	41	48

Reasons for withdrawal

Reasons for withdrawal
Measure	DRV/Rtv 800/100 mg Once Daily Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Overall Study Adverse Event	10	12
Overall Study Lost to Follow-up	9	13
Overall Study Withdrawal by Subject	4	5
Overall Study Non-compliant	8	9
Overall Study Reached a Virologic Endpoint	3	2
Overall Study Sponsor's Decision	2	0
Overall Study Ineligible to Continue the study	2	5
Overall Study Other	3	2

Baseline Characteristics

A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily	Total n=590 Participants Total of all reporting groups
Age Continuous	40.2 years STANDARD_DEVIATION 9.09 • n=5 Participants	40.7 years STANDARD_DEVIATION 9.50 • n=7 Participants	40.5 years STANDARD_DEVIATION 9.29 • n=5 Participants
Sex: Female, Male Female	115 Participants n=5 Participants	98 Participants n=7 Participants	213 Participants n=5 Participants
Sex: Female, Male Male	179 Participants n=5 Participants	198 Participants n=7 Participants	377 Participants n=5 Participants
Age (years) (categorical) Age <= 30	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants
Age (years) (categorical) 30 < Age <= 45	180 participants n=5 Participants	169 participants n=7 Participants	349 participants n=5 Participants
Age (years) (categorical) 45 < Age <= 55	64 participants n=5 Participants	72 participants n=7 Participants	136 participants n=5 Participants
Age (years) (categorical) 55 < Age <= 65	14 participants n=5 Participants	18 participants n=7 Participants	32 participants n=5 Participants
Age (years) (categorical) Age > 65	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Hepatitis B or C Co-infection Status Negative	267 participants n=5 Participants	255 participants n=7 Participants	522 participants n=5 Participants
Hepatitis B or C Co-infection Status Positive	25 participants n=5 Participants	37 participants n=7 Participants	62 participants n=5 Participants
Hepatitis B or C Co-infection Status Unknown	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.

Outcome measures

Outcome measures
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm	212 Participants	210 Participants

SECONDARY outcome

Timeframe: 48 weeks

Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48.

Outcome measures

Outcome measures
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)	226 Participants	227 Participants

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome measures
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Change in log10 Viral Load From Baseline at Week 48 Log10 Viral Load at baseline	4.23 log10 copies/mL Interval 1.73 to 6.43	4.134 log10 copies/mL Interval 1.69 to 5.98
Change in log10 Viral Load From Baseline at Week 48 Log10 Viral Load change from baseline at Week 48	-2.11 log10 copies/mL Interval -4.7 to 2.0	-2.13 log10 copies/mL Interval -4.2 to 2.4

SECONDARY outcome

Timeframe: 48 weeks

Time (in weeks) to achieve viral load less than 50 copies/mL by the participants.

Outcome measures

Outcome measures
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Time to Reach First Virologic Response	85 Days Interval 71.0 to 86.0	85 Days Interval 83.0 to 85.0

SECONDARY outcome

Timeframe: 48 weeks

Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants.

Outcome measures

Outcome measures
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Time to Loss of Virologic Response	250.235 Days Standard Error 6.598	281.743 Days Standard Error 7.47

SECONDARY outcome

Timeframe: 48 weeks

Population: Intention To Treat (ITT) population: Observed cases

Outcome measures

Outcome measures
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks	-1.77 log10 copies/mL Standard Error 0.051	-1.74 log10 copies/mL Standard Error 0.051

SECONDARY outcome

Timeframe: 48 Weeks

Population: Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.

CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm.

Outcome measures

Outcome measures
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Change in CD4+ Cell Count From Baseline Value at Baseline	219 10e6/l Interval 24.0 to 1306.0	236 10e6/l Interval 44.0 to 864.0
Change in CD4+ Cell Count From Baseline CD4+ cell count change from baseline at Week 48	100 10e6/l Interval -242.0 to 808.0	94 10e6/l Interval -239.0 to 639.0

SECONDARY outcome

Timeframe: 48 weeks

The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening.

Outcome measures

Outcome measures
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score FAHI score at baseline	129 Scores on a scale Interval 31.0 to 175.0	123.5 Scores on a scale Interval 33.0 to 174.0
Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score Change from baseline in FAHI score at Week 48	2.5 Scores on a scale Interval -74.0 to 81.0	0.0 Scores on a scale Interval -75.0 to 81.0

SECONDARY outcome

Timeframe: 48 weeks

Population: Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.

Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days.

Outcome measures

Outcome measures
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 Adherent	67.4 Percentage of participants	60.3 Percentage of participants
Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48 Non-adherent	32.6 Percentage of participants	39.7 Percentage of participants

SECONDARY outcome

Timeframe: 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48.

Population: Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.

Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.

Outcome measures

Outcome measures
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv Population Pharmacokinetic Estimates of DRV	87788 ng*h/mL Interval 45456.0 to 236920.0	109401 ng*h/mL Interval 48934.0 to 323820.0
Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv Population Pharmacokinetic Estimates of rtv	5776 ng*h/mL Interval 1801.0 to 39027.0	12588 ng*h/mL Interval 3404.0 to 44762.0

SECONDARY outcome

Timeframe: 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48

Population: Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.

Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.

Outcome measures

Outcome measures
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Predose Plasma Concentration (C0h) of DRV and Rtv. Population Pharmacokinetic Estimates of DRV	1896 ng/mL Interval 184.0 to 7881.0	3197 ng/mL Interval 250.0 to 11865.0
Predose Plasma Concentration (C0h) of DRV and Rtv. Population Pharmacokinetic Estimates of rtv	59 ng/mL Interval 6.0 to 1049.0	307 ng/mL Interval 41.0 to 1657.0

SECONDARY outcome

Timeframe: 48 weeks

Population: Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.

Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint.

Outcome measures

Outcome measures
Measure	DRV/Rtv 800/100 mg Once Daily n=294 Participants Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 Participants One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Number of Participants Developing Mutations at Endpoint DRV resistance-associated mutation (RAM)	1 Participants	0 Participants
Number of Participants Developing Mutations at Endpoint Primary (major) protease inhibitor (PI) mutations	1 Participants	0 Participants
Number of Participants Developing Mutations at Endpoint Protease inhibitor (PI) RAMs	7 Participants	4 Participants
Number of Participants Developing Mutations at Endpoint Nucleoside reverse transcriptase inhibitor RAMs	4 Participants	3 Participants

Adverse Events

DRV/Rtv 800/100 mg Once Daily

Serious events: 16 serious events

Other events: 134 other events

Deaths: 0 deaths

DRV/Rtv 600/100 mg Twice Daily

Serious events: 27 serious events

Other events: 147 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DRV/Rtv 800/100 mg Once Daily n=294 participants at risk Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 participants at risk One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Infections and infestations Pneumonia	1.0% 3/294 • 52 weeks	1.0% 3/296 • 52 weeks
Infections and infestations Dermo-hypodermitis	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Infections and infestations Escherichia urinary tract infection	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Infections and infestations Gastroenteritis cryptosporidial	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Infections and infestations Lung infection	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Infections and infestations Mastoiditis	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Infections and infestations Peritonitis bacterial	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Infections and infestations Sepsis	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Infections and infestations Toxoplasmosis	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Infections and infestations Appendicitis	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Infections and infestations Bronchopneumonia	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Infections and infestations Extrapulmonary tuberculosis	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Infections and infestations Infected cyst	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Infections and infestations Influenza	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Infections and infestations Lobar pneumonia	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Infections and infestations Malaria	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/294 • 52 weeks	0.68% 2/296 • 52 weeks
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Respiratory, thoracic and mediastinal disorders Pulmonary bulla	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Blood and lymphatic system disorders Anaemia	0.00% 0/294 • 52 weeks	0.68% 2/296 • 52 weeks
Blood and lymphatic system disorders Bicytopenia	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Blood and lymphatic system disorders Lymphadenopathy	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Renal and urinary disorders Calculus ureteric	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Renal and urinary disorders Nephrolithiasis	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Renal and urinary disorders Renal failure acute	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Cardiac disorders Cardiac failure congestive	0.00% 0/294 • 52 weeks	0.68% 2/296 • 52 weeks
Cardiac disorders Atrioventricular block first degree	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Cardiac disorders Sinus bradycardia	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Cardiac disorders Cardio-respiratory arrest	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Hepatobiliary disorders Bile duct obstruction	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Hepatobiliary disorders Hepatitis	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Injury, poisoning and procedural complications Concussion	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Injury, poisoning and procedural complications Drug toxicity	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Injury, poisoning and procedural complications Skin laceration	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Injury, poisoning and procedural complications Whiplash injury	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Injury, poisoning and procedural complications Overdose	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Injury, poisoning and procedural complications Post procedural bile leak	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Psychiatric disorders Anxiety	0.00% 0/294 • 52 weeks	0.68% 2/296 • 52 weeks
Psychiatric disorders Abnormal behaviour	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Psychiatric disorders Suicidal ideation	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Psychiatric disorders Suicide attempt	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Gastrointestinal disorders Abdominal pain	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Gastrointestinal disorders Vomiting	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
General disorders Drug interaction	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
General disorders Pyrexia	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Investigations Weight decreased	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Nervous system disorders Carpal tunnel syndrome	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Nervous system disorders Carotid artery aneurysm	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Skin and subcutaneous tissue disorders Angiodermatitis	0.00% 0/294 • 52 weeks	0.34% 1/296 • 52 weeks
Eye disorders Retinal detachment	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Reproductive system and breast disorders Vulval ulceration	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Surgical and medical procedures Intervertebral disc operation	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks
Vascular disorders Deep vein thrombosis	0.34% 1/294 • 52 weeks	0.00% 0/296 • 52 weeks

Other adverse events

Other adverse events
Measure	DRV/Rtv 800/100 mg Once Daily n=294 participants at risk Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily	DRV/Rtv 600/100 mg Twice Daily n=296 participants at risk One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
Gastrointestinal disorders Diarrhoea	14.3% 42/294 • 52 weeks	22.3% 66/296 • 52 weeks
Gastrointestinal disorders Nausea	12.9% 38/294 • 52 weeks	14.2% 42/296 • 52 weeks
Gastrointestinal disorders Vomiting	4.4% 13/294 • 52 weeks	8.4% 25/296 • 52 weeks
Infections and infestations Nasopharyngitis	6.5% 19/294 • 52 weeks	6.4% 19/296 • 52 weeks
Infections and infestations Influenza	5.8% 17/294 • 52 weeks	6.1% 18/296 • 52 weeks
Infections and infestations Upper respiratory tract infection	5.8% 17/294 • 52 weeks	6.1% 18/296 • 52 weeks
Infections and infestations Bronchitis	5.4% 16/294 • 52 weeks	3.7% 11/296 • 52 weeks
Nervous system disorders Headache	6.8% 20/294 • 52 weeks	6.8% 20/296 • 52 weeks
Skin and subcutaneous tissue disorders Rash	5.1% 15/294 • 52 weeks	4.7% 14/296 • 52 weeks
Musculoskeletal and connective tissue disorders Back pain	5.4% 16/294 • 52 weeks	3.7% 11/296 • 52 weeks

Additional Information

Medical Leader

Tibotec Pharmaceuticals, Ireland

Phone: +32 015 461 497

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor will not unreasonably withhold consent to publish the data generated in this trial. However, it is the policy of the Sponsor not to allow the investigators to publish their results or findings prior to the Sponsor's publication of the overall trial results. The investigator agrees that before he/she publishes any results of this trial, he/she shall allow at least 45 days for the Sponsor to review the prepublication manuscript prior to submission of the manuscript to the publisher.
Publication restrictions are in place

Restriction type: OTHER