Trial Outcomes & Findings for A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment (NCT NCT01448707)

NCT ID: NCT01448707

Last Updated: 2017-11-27

Results Overview

The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels \<50 copies/milliliters \[mL\] after 48 weeks of follow-up. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N\[t\]RTIs) not permitted by the trial protocol or plasma HIV-1 RNA assessment closest to target date of the analysis time point window (44-52 weeks) and next/confirmation of Plasma HIV-1 RNA in the analysis time point window above the threshold or discontinuation for any other reason.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 274 participants
• Primary outcome timeframe: Week 48
• Results posted on: 2017-11-27

Participant Flow

325 participants screened, among them 282 were eligible for run-in phase and among them 274 enrolled to the study. 1 randomized participant was not treated (274 participants were randomized).

Participant milestones

Measure	DRV/Rtv MONO Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.	DRV/Rtv + 2NRTIs Darunavir (DRV), ritonavir (rtv) and 2 N\[t\]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
Overall Study STARTED	137	136
Overall Study COMPLETED	119	118
Overall Study NOT COMPLETED	18	18

Reasons for withdrawal

Measure	DRV/Rtv MONO Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.	DRV/Rtv + 2NRTIs Darunavir (DRV), ritonavir (rtv) and 2 N\[t\]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
Overall Study Adverse Event	3	1
Overall Study Lost to Follow-up	2	6
Overall Study Withdrawal by Subject	6	7
Overall Study Other	7	4

Baseline Characteristics

A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment

Baseline characteristics by cohort

Measure	DRV/Rtv MONO n=137 Participants Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.	DRV/Rtv + 2NRTIs n=136 Participants Darunavir (DRV), ritonavir (rtv) and 2 N\[t\]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).	Total n=273 Participants Total of all reporting groups
Age, Continuous	44.6 years STANDARD_DEVIATION 11.21 • n=5 Participants	43.1 years STANDARD_DEVIATION 10.41 • n=7 Participants	43.9 years STANDARD_DEVIATION 10.82 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	21 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants	115 Participants n=7 Participants	226 Participants n=5 Participants
Region of Enrollment AUSTRIA	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment BELGIUM	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment DENMARK	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment FRANCE	16 participants n=5 Participants	12 participants n=7 Participants	28 participants n=5 Participants
Region of Enrollment GERMANY	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
Region of Enrollment HUNGARY	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment IRELAND	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment ISRAEL	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment ITALY	22 participants n=5 Participants	24 participants n=7 Participants	46 participants n=5 Participants
Region of Enrollment POLAND	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment SPAIN	17 participants n=5 Participants	23 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment SWEDEN	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment SWITZERLAND	10 participants n=5 Participants	5 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment UNITED KINGDOM	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.

The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 48 weeks of follow-up. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) not permitted by the trial protocol or plasma HIV-1 RNA assessment closest to target date of the analysis time point window (44-52 weeks) and next/confirmation of Plasma HIV-1 RNA in the analysis time point window above the threshold or discontinuation for any other reason.

Outcome measures

Measure	DRV/r n=137 Participants Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.	DRV/r + 2NRTIs n=136 Participants Darunavir (DRV) + ritonavir (rtv) + 2 N\[t\]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)	87.0 Percentage of Participants	95.0 Percentage of Participants

SECONDARY outcome

Timeframe: Week 96

Population: The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.

The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) not permitted by the trial protocol.

Outcome measures

Measure	DRV/r n=137 Participants Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.	DRV/r + 2NRTIs n=136 Participants Darunavir (DRV) + ritonavir (rtv) + 2 N\[t\]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)	75.2 Percentage of Participants	85.3 Percentage of Participants

SECONDARY outcome

Timeframe: Week 48 and 96

Population: The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.

The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 48 and 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch included is defined as all participants who discontinued randomized medication were followed up on their subsequent treatment.

Outcome measures

Measure	DRV/r n=137 Participants Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.	DRV/r + 2NRTIs n=136 Participants Darunavir (DRV) + ritonavir (rtv) + 2 N\[t\]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Virologic Response (FDA Snapshot, Switch Included) Week 48	93.0 Percentage of Participants	96.5 Percentage of Participants
Virologic Response (FDA Snapshot, Switch Included) Week 96	89.3 Percentage of Participants	89.9 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 48 and 96

Population: The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.

Change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Neurocognitive function will be measured by Hopkins Verbal Learning Test (verbal learning and memory), Colour Trail Test (psychomotor speed and cognitive flexibility) and Grooved Pegboard Test (psychomotor speed and fine motor function). Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP).

Outcome measures

Measure	DRV/r n=137 Participants Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.	DRV/r + 2NRTIs n=136 Participants Darunavir (DRV) + ritonavir (rtv) + 2 N\[t\]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Change From Baseline in Global Neurocognitive Performance z-Score Change at Week 48	0.39 Units on a Scale Standard Error 0.048	0.42 Units on a Scale Standard Error 0.057
Change From Baseline in Global Neurocognitive Performance z-Score Change at Week 96	0.63 Units on a Scale Standard Error 0.060	0.57 Units on a Scale Standard Error 0.057

SECONDARY outcome

Timeframe: Baseline up to Week 96 or early withdrawal

Population: The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.

Time (in days) it takes to show loss of response per time to loss of virologic response (TLOVR) algorithm: confirmed HIV-1 RNA >= 50 copies/mL or premature discontinuation.

Outcome measures

Measure	DRV/r n=137 Participants Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.	DRV/r + 2NRTIs n=136 Participants Darunavir (DRV) + ritonavir (rtv) + 2 N\[t\]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Time to Loss of Virologic Response	NA Days Full Range 19.92 The event occurred in less than 50 percent of the participants.	NA Days Full Range 18.88 The event occurred in less than 50 percent of the participants.

SECONDARY outcome

Timeframe: At Weeks 48 and 96

Population: The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.

The loss of treatment options of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96, as defined by treatment-emergent phenotypic drug resistance. Drug resistance is classified as: 1) Confirmed HIV RNA >= 400 copies/mL, 2) Post-baseline phenotypic data and 3) Phenotypic resistance to any of the drug classes (NRTI, NNRTI, or PI).

Outcome measures

Measure	DRV/r n=137 Participants Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.	DRV/r + 2NRTIs n=136 Participants Darunavir (DRV) + ritonavir (rtv) + 2 N\[t\]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance Phenotypic resistance to any of the drug classes	0 Participants	0 Participants
Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance Confirmed HIV RNA >= 400 copies/mL	1 Participants	2 Participants
Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance Post-baseline phenotypic data	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Over 48 and 96 Weeks

Population: The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.

The viral genotype of participants treated with DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Genotypic resistance (number of resistance mutations) at any time point when a participant had a confirmed plasma VL >400 copies/mL after randomization was performed per treatment group for the ITT population. Results were summarized based on individual treatment received: Darunavir resistance mutations, non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations, nucleoside reverse transcriptase inhibitor (NRTI) mutations, protease inhibitor (PI) resistance mutations, PR mutations, RT mutations, extended NNRTI mutations, primary PI mutations.

Outcome measures

Measure	DRV/r n=137 Participants Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.	DRV/r + 2NRTIs n=136 Participants Darunavir (DRV) + ritonavir (rtv) + 2 N\[t\]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Participans with HIV RNA >= 400 copies/mL	1 Participants	2 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of 0 Darunavir resistance mutations	2 Participants	1 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of 0 NNRTI mutations	2 Participants	0 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of 1 NNRTI mutations	0 Participants	1 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of 1 PI resistance mutations	1 Participants	0 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of 5 PI resistance mutations	0 Participants	1 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of 6 PI resistance mutations	1 Participants	0 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of 11 PR mutations	0 Participants	1 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of 15 PR mutations	1 Participants	0 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of 7 PR mutations	1 Participants	0 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of 14 RT mutations	1 Participants	0 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of 16 RT mutations	0 Participants	1 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of 33 RT mutations	1 Participants	0 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of extended 0 NNRTI mutations	2 Participants	0 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of extended 1 NNRTI mutations	0 Participants	1 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of primary 0 PI mutations	2 Participants	1 Participants
Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results Number of participants with no mutations	0 Participants	0 Participants

Adverse Events

DRV/Rtv MONO

Serious events: 18 serious events

Other events: 61 other events

Deaths: 0 deaths

DRV/Rtv + 2NRTIs

Serious events: 14 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure	DRV/Rtv MONO n=137 participants at risk Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.	DRV/Rtv + 2NRTIs n=136 participants at risk Darunavir (DRV), ritonavir (rtv) and 2 N\[t\]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
Blood and lymphatic system disorders Anaemia	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Blood and lymphatic system disorders Lymphadenopathy	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Cardiac disorders Cardiac Arrest	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Gastrointestinal disorders Anal Fistula	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
General disorders Pyrexia	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
General disorders Tenderness	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Immune system disorders Hypersensitivity	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Abscess	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Cellulitis	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Cytomegalovirus Infection	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Gastroenteritis Viral	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Groin Abscess	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Hepatitis B	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Hepatitis C	1.5% 2/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Meningitis	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Pharyngitis Bacterial	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Pyelonephritis	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Sepsis	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Shigella Infection	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Injury, poisoning and procedural complications Facial Bones Fracture	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Injury, poisoning and procedural complications Laceration	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Injury, poisoning and procedural complications Laryngeal Injury	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Injury, poisoning and procedural complications Post Lumbar Puncture Syndrome	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Injury, poisoning and procedural complications Radius Fracture	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital Warts	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's Disease	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse Large B-Cell Lymphoma	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Nervous system disorders Central Nervous System Lesion	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Nervous system disorders Encephalomyelitis	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Nervous system disorders Headache	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Nervous system disorders Ischaemic Stroke	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Nervous system disorders Lethargy	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Nervous system disorders Optic Neuritis	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Psychiatric disorders Alcoholism	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Psychiatric disorders Substance Abuse	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Renal and urinary disorders Calculus Urinary	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Renal and urinary disorders Renal Failure	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Renal and urinary disorders Urinary Retention	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal Obstruction	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Skin and subcutaneous tissue disorders Excessive Granulation Tissue	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash Pruritic	0.73% 1/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Skin and subcutaneous tissue disorders Skin Ulcer	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Surgical and medical procedures Gastrectomy	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Surgical and medical procedures Tonsillectomy	0.00% 0/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.74% 1/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.

Other adverse events

Measure	DRV/Rtv MONO n=137 participants at risk Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.	DRV/Rtv + 2NRTIs n=136 participants at risk Darunavir (DRV), ritonavir (rtv) and 2 N\[t\]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N\[t\]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
Gastrointestinal disorders Diarrhoea	13.1% 18/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	7.4% 10/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
General disorders Fatigue	5.1% 7/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	5.1% 7/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
General disorders Pyrexia	2.9% 4/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	5.1% 7/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Infections and infestations Nasopharyngitis	11.7% 16/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	8.1% 11/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Metabolism and nutrition disorders Hypercholesterolaemia	5.1% 7/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	0.00% 0/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	5.1% 7/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	5.1% 7/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back Pain	7.3% 10/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	2.9% 4/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Nervous system disorders Headache	5.8% 8/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	6.6% 9/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Psychiatric disorders Depression	2.9% 4/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	5.1% 7/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	5.8% 8/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	5.9% 8/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash	5.1% 7/137 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.	2.2% 3/136 • Baseline up to 96 weeks The Safety (SAF) population is the set of all participants who took at least one dose of study medication.

Additional Information

EMEA Medical Affairs Program Lead

Janssen Research & Development, LLC

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days. The sponsor will not mandate modifications to scientific content and does not have the right to suppress information.
• Publication restrictions are in place

Restriction type: OTHER