Trial Outcomes & Findings for TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients (NCT NCT00896051)
NCT ID: NCT00896051
Last Updated: 2013-09-30
Results Overview
The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Day -1 (Reference); Week 2 (Test)
Results posted on
2013-09-30
Participant Flow
Etravirine coadministered with 2 doses of atazanavir/low-dose ritonavir each combined with 1 nucleoside reverse transcriptase inhibitor was evaluated in human immunodeficiency virus - type 1 infected participants. The study was conducted between 25 June 2009 and 10 April 2012 and participants were recruited by 17 investigators in 4 countries.
Fifty (50) participants were enrolled in the study and received treatment with study drug during a 2-week Pre-treatment Period (Week -2 to Day -1) and a 48-week Treatment Period (Day 1 to Week 48). Efficacy data are reported for the 48-week Treatment Period.
Participant milestones
| Measure |
ATV/Rtv 300/100 mg (Treatment A)
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
|
ATV/Rtv 400/100 mg (Treatment B)
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
| Measure |
ATV/Rtv 300/100 mg (Treatment A)
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
|
ATV/Rtv 400/100 mg (Treatment B)
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Subject noncompliant
|
1
|
3
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
Baseline characteristics by cohort
| Measure |
ATV/Rtv 300/100 mg (Treatment A)
n=25 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
|
ATV/Rtv 400/100 mg (Treatment B)
n=25 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
41.2 years
STANDARD_DEVIATION 10.44 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 9.37 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 9.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day -1 (Pretreatment); Week 2 (Test)Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the PK parameter reported.
The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax).
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=21 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=19 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)
C0h, ng/ml (Reference, n=21; Test, n=19)
|
1339 ng/ml
Standard Deviation 1728
|
845.7 ng/ml
Standard Deviation 703.3
|
|
Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)
Cmin, ng/ml (Reference, n=20; Test, n=18)
|
1104 ng/ml
Standard Deviation 1511
|
758.6 ng/ml
Standard Deviation 610.5
|
|
Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)
Cmax, ng/ml (Reference, n=20; Test, n=19)
|
5652 ng/ml
Standard Deviation 2735
|
5232 ng/ml
Standard Deviation 2166
|
PRIMARY outcome
Timeframe: Day -1 (Pretreatment); Week 2 (Test)Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the PK parameter reported.
The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=19 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=18 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for AUC24hr)
|
60030 ng.h/mL
Standard Deviation 39690
|
55070 ng.h/mL
Standard Deviation 21860
|
PRIMARY outcome
Timeframe: Day -1 (Reference); Week 2 (Test)Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).
The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=21 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=20 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)
C0h, ng/ml (Reference, n=22; Test, n=20)
|
1898 ng/ml
Standard Deviation 2298
|
1545 ng/ml
Standard Deviation 1296
|
|
Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)
Cmin, ng/ml (Reference, n=21;Test, n=18)
|
1671 ng/ml
Standard Deviation 2310
|
1107 ng/ml
Standard Deviation 866.8
|
|
Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)
Cmax, ng/ml (Reference, n=22; Test, n=20)
|
6419 ng/ml
Standard Deviation 2853
|
6950 ng/ml
Standard Deviation 2693
|
PRIMARY outcome
Timeframe: Day -1 (Reference); Week 2 (Test)Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.
The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=21 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=19 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for AUC24hr)
|
74210 ng.h/mL
Standard Deviation 55480
|
72220 ng.h/mL
Standard Deviation 34600
|
PRIMARY outcome
Timeframe: Day -1 (Reference); Week 2 (Test)Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.
The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax).
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=21 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=19 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)
C0h, ng/ml (Reference, n=21; Test, n=19)
|
143.4 ng/ml
Standard Deviation 269.8
|
102.5 ng/ml
Standard Deviation 157.2
|
|
Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)
Cmin, ng/ml (Reference, n=20; Test, n=18)
|
60.42 ng/ml
Standard Deviation 73.17
|
43.97 ng/ml
Standard Deviation 36.29
|
|
Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)
Cmax, ng/ml (Reference, n=20; Test, n=19)
|
1834 ng/ml
Standard Deviation 1009
|
1740 ng/ml
Standard Deviation 1149
|
PRIMARY outcome
Timeframe: Day -1 (Reference); Week 2 (Test)Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.
The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=19 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=18 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for AUC24hr)
|
12560 ng.h/ml
Standard Deviation 6643
|
11120 ng.h/ml
Standard Deviation 6658
|
PRIMARY outcome
Timeframe: Day -1 (Reference); Week 2 (Test)Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.
The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=20 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=19 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)
C0h, ng/ml (Reference, n=22; Test, n=20)
|
109.2 ng/ml
Standard Deviation 94.50
|
163.4 ng/ml
Standard Deviation 240.2
|
|
Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)
Cmin, ng/ml
|
64.70 ng/ml
Standard Deviation 51.80
|
75.68 ng/ml
Standard Deviation 69.98
|
|
Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)
Cmax, ng/ml (Reference, n=22)
|
1882 ng/ml
Standard Deviation 1026
|
1847 ng/ml
Standard Deviation 859.9
|
PRIMARY outcome
Timeframe: Day -1 (Reference); Week 2 (Test)Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.
The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=20 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=19 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for AUC24hr)
|
13880 ng.h/ml
Standard Deviation 8198
|
13660 ng.h/ml
Standard Deviation 6778
|
PRIMARY outcome
Timeframe: Week 2Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.
The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin) and maximum plasma concentration (Cmax).
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=19 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=20 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)
C0h (Treatment B, n=19)
|
422.2 ng/ml
Standard Deviation 327.9
|
316.6 ng/ml
Standard Deviation 215.4
|
|
Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)
Cmin (Treatment A, n=16; Treatment B, n=18)
|
425.1 ng/ml
Standard Deviation 328.1
|
286.5 ng/ml
Standard Deviation 198.0
|
|
Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)
Cmax (Treatment A, n=18; Treatment B, n=18)
|
773.0 ng/ml
Standard Deviation 360.5
|
628.7 ng/ml
Standard Deviation 294.0
|
PRIMARY outcome
Timeframe: Week 2Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.
The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the area under the plasma concentration-time curve from time of intake to 12 hours after dosing (AUC12hr).
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=18 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=18 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Pharmacokinetic Results of Etravirine (ETR) (Results for AUC12hr)
|
7629 ng.h/mL
Standard Deviation 4213
|
5171 ng.h/mL
Standard Deviation 2695
|
PRIMARY outcome
Timeframe: Week 48Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).
The table below shows the percentage of participants wih undetectable plasma viral load (VL) values (\<50 copies/mL) at Week 48 using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their baseline value, thus resulting in a 0 change).
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Percentage of Participants With Undetectable Plasma Viral Load (VL) Values (<50 Copies/mL) at Week 48
|
50.0 Percentage of Participants
Interval 28.2 to 71.8
|
45.5 Percentage of Participants
Interval 45.5 to 67.8
|
SECONDARY outcome
Timeframe: Prebaseline, Baseline, Weeks 4, 12, 24, 48Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).
The table below shows the mean change from prebaseline over time in CD4+ cell count using the Non-Completing = Failure (NC=F) imputation method.
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Change From Prebaseline in CD4+ Cell Count Over Time
Week 12
|
31 CD4+ cell count
Standard Error 15.0
|
72 CD4+ cell count
Standard Error 23.5
|
|
Change From Prebaseline in CD4+ Cell Count Over Time
Baseline
|
16 CD4+ cell count
Standard Error 11.8
|
8 CD4+ cell count
Standard Error 18
|
|
Change From Prebaseline in CD4+ Cell Count Over Time
Week 4
|
55 CD4+ cell count
Standard Error 15.4
|
46 CD4+ cell count
Standard Error 27.4
|
|
Change From Prebaseline in CD4+ Cell Count Over Time
Week 24
|
54 CD4+ cell count
Standard Error 22.0
|
83 CD4+ cell count
Standard Error 23.2
|
|
Change From Prebaseline in CD4+ Cell Count Over Time
Week 48
|
105 CD4+ cell count
Standard Error 31.1
|
132 CD4+ cell count
Standard Error 32.6
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 48Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).
The table below shows the percentage of participants per time point with a virologic response defined as having a plasma viral load (VL) \<50 copies/mL, and with plasma VL \<400 copies/mL using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their Baseline value, thus resulting in a 0 change).
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
<50 copies/mL, Baseline
|
9.1 Percentage of Participants
|
9.1 Percentage of Participants
|
|
The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
<50 copies/mL, Week 4
|
31.8 Percentage of Participants
|
36.4 Percentage of Participants
|
|
The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
<50 copies/mL, Week 12
|
59.1 Percentage of Participants
|
59.1 Percentage of Participants
|
|
The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
<50 copies/mL, Week 24
|
63.6 Percentage of Participants
|
63.6 Percentage of Participants
|
|
The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
<50 copies/mL, Week 48
|
50.0 Percentage of Participants
|
45.5 Percentage of Participants
|
|
The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
<400 copies/mL, Baseline
|
40.9 Percentage of Participants
|
40.9 Percentage of Participants
|
|
The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
<400 copies/mL, Week 4
|
77.3 Percentage of Participants
|
77.3 Percentage of Participants
|
|
The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
<400 copies/mL, Week 12
|
68.2 Percentage of Participants
|
81.8 Percentage of Participants
|
|
The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
<400 copies/mL, Week 24
|
72.7 Percentage of Participants
|
72.7 Percentage of Participants
|
|
The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
<400 copies/mL, Week 48
|
50.0 Percentage of Participants
|
59.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 24, 48Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).
The table below shows the percentage of participants with a virologic response defined as a viral load \<50 Copies/mL and \<400 Copies/mL per time point calculated using the time to loss of virologic response (TLOVR) imputation method.
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
<400 copies/mL, Week 48
|
59.1 Percentage of Particpants
|
54.5 Percentage of Particpants
|
|
The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
<50 copies/mL, Baseline
|
9.1 Percentage of Particpants
|
4.5 Percentage of Particpants
|
|
The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
<50 copies/mL, Week 4
|
31.8 Percentage of Particpants
|
36.4 Percentage of Particpants
|
|
The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
<50 copies/mL, Week 12
|
59.1 Percentage of Particpants
|
54.5 Percentage of Particpants
|
|
The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
<50 copies/mL, Week 24
|
63.6 Percentage of Particpants
|
59.1 Percentage of Particpants
|
|
The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
<50 copies/mL, Week 48
|
45.5 Percentage of Particpants
|
50.0 Percentage of Particpants
|
|
The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
<400 copies/mL, Baseline
|
36.4 Percentage of Particpants
|
40.9 Percentage of Particpants
|
|
The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
<400 copies/mL, Week 4
|
77.3 Percentage of Particpants
|
77.3 Percentage of Particpants
|
|
The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
<400 copies/mL, Week 12
|
68.2 Percentage of Particpants
|
86.4 Percentage of Particpants
|
|
The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
<400 copies/mL, Week 24
|
68.2 Percentage of Particpants
|
68.2 Percentage of Particpants
|
SECONDARY outcome
Timeframe: Week 48Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).
The table below provides the results from the snapshot analysis method that includes the percentage of participants with virologic response (\<50 copies/mL), the percentage of participants who were virologic failures (VF) (\>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load \>50 copies/mL), and the percentage of participants with no viral load (VL) data available at Week 48.
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method
Virologic Response
|
50.0 Percentage of Participants
|
45.5 Percentage of Participants
|
|
The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method
Virologic Failure
|
31.8 Percentage of Participants
|
36.4 Percentage of Participants
|
|
The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method
No VL Data Available
|
18.2 Percentage of Participants
|
18.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Pre-Baseline, Baseline, Weeks 4, 12, 24, 48Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).
The table below shows the mean change from prebaseline over time in log10 (Copies/mL) plasma viral load using the Non-Completing = Failure (NC=F) imputation method.
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Change From Pre-Baseline in Log10 Viral Load Over Time
Baseline
|
-1.4 log10 (Copies/mL)
Standard Error 0.14
|
-1.4 log10 (Copies/mL)
Standard Error 0.18
|
|
Change From Pre-Baseline in Log10 Viral Load Over Time
Week 4
|
-1.9 log10 (Copies/mL)
Standard Error 0.18
|
-1.8 log10 (Copies/mL)
Standard Error 0.15
|
|
Change From Pre-Baseline in Log10 Viral Load Over Time
Week 12
|
-1.7 log10 (Copies/mL)
Standard Error 0.26
|
-2.0 log10 (Copies/mL)
Standard Error 0.23
|
|
Change From Pre-Baseline in Log10 Viral Load Over Time
Week 24
|
-1.8 log10 (Copies/mL)
Standard Error 0.24
|
-1.8 log10 (Copies/mL)
Standard Error 0.27
|
|
Change From Pre-Baseline in Log10 Viral Load Over Time
Week 48
|
-1.4 log10 (Copies/mL)
Standard Error 0.24
|
-1.4 log10 (Copies/mL)
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Prebaseline to Week 48Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).
The table below provides the time in days it took participants to reach a confirmed virologic response defined as a plasma viral load (VL) \<50 copies/mL, and plasma VL \<400 copies/mL analyzed according to the Time to Loss of Virologic Response (TLOVR) imputation method.
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Time to Confirmed Virologic Response
Plasma VL < 400 copies/mL
|
28.0 Days
95% Confidence Interval 5.02 • Interval 15.0 to 43.0
|
28.0 Days
95% Confidence Interval 6.47 • Interval 15.0 to 43.0
|
|
Time to Confirmed Virologic Response
Plasma VL < 50 copies/mL
|
71.0 Days
95% Confidence Interval 10.87 • Interval 44.0 to 129.0
|
76.0 Days
95% Confidence Interval 9.95 • Interval 42.0 to 99.0
|
SECONDARY outcome
Timeframe: Prebaseline to Week 48Population: The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).
The table below shows the number of days to virologic failure defined as a plasma viral load (VL) \> 50 copies/mL for participants who had been virologic responders (ie, having a plasma VL \<50, and \<400 copies/mL according to the time to loss of virologic response \[TLOVR\] imputation method). Time to virologic failure was the time to subsequent loss of virologic response, and the time was calculated from Prebaseline (Week -2). Participants who never achieved a virologic response were defined as nonresponders and counted as virologic failures on Day 1.
Outcome measures
| Measure |
ATV/Rtv 300/100 mg (Reference)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
|
ATV/Rtv 300/100 mg (Test)
n=22 Participants
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
|
|---|---|---|
|
Time to Virologic Failure
Virologic Responders (Plasma VL < 50 copies/mL)
|
318.0 Days
95% Confidence Interval 31.90 • Interval 78.0 to
The upper limit of the 95% CI could not be assessed because a sufficient number of participants did not experience virologic failure.
|
NA Days
95% Confidence Interval 22.46
Median cannot be assessed since less than 50% of participants experienced virologic failure.
|
|
Time to Virologic Failure
Virologic Responders (Plasma VL < 400 copies/mL)
|
NA Days
95% Confidence Interval 28.92
Median cannot be assessed since less than 50% of participants experienced virologic failure
|
NA Days
95% Confidence Interval 17.28
Median cannot be assessed since less than 50% of participants experienced virologic failure
|
Adverse Events
ATV/Rtv 300/100 mg (Treatment A)
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
ATV/Rtv 400/100 mg (Treatment B)
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ATV/Rtv 300/100 mg (Treatment A)
n=25 participants at risk
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
|
ATV/Rtv 400/100 mg (Treatment B)
n=25 participants at risk
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Infections and infestations
Gastroenteritis
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Infections and infestations
Meningitis aseptic
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Infections and infestations
Pneumonia
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Nervous system disorders
Headache
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
Other adverse events
| Measure |
ATV/Rtv 300/100 mg (Treatment A)
n=25 participants at risk
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
|
ATV/Rtv 400/100 mg (Treatment B)
n=25 participants at risk
Treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
12.0%
3/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Infections and infestations
Bronchitis
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Infections and infestations
Influenza
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
12.0%
3/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Infections and infestations
Sinusitis
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
12.0%
3/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Investigations
Blood bilirubin increased
|
12.0%
3/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Nervous system disorders
Headache
|
12.0%
3/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
12.0%
3/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Nervous system disorders
Neuropathy peripheral
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
5/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
16.0%
4/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.0%
3/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Gastrointestinal disorders
Nausea
|
16.0%
4/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
General disorders
Fatigue
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
General disorders
Pyrexia
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Hepatobiliary disorders
Jaundice
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Psychiatric disorders
Anxiety disorder
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Psychiatric disorders
Depression
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
0.00%
0/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.0%
1/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
8.0%
2/25 • Up to a maximum of 56 weeks.
To also include the safety data of 6 participants who discontinued during the Pretreatment Period, the safety analyses were performed on the ITT population defined as all participants who had at least 1 atazanavir (ATV)/low dose ritonavir (rtv) intake regardless of their compliance with the protocol (ie, the 'safety ITT population').
|
Additional Information
Senior Director
Tibotec
Phone: +32 (0) 14 641 265
Results disclosure agreements
- Principal investigator is a sponsor employee It is the policy of the sponsor not to allow investigators to publish their results or findings from the study 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