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Trial record 19 of 37 for:    " April 15, 2009":" May 15, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

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ClinicalTrials.gov Identifier: NCT00896051
Recruitment Status : Completed
First Posted : May 11, 2009
Results First Posted : September 30, 2013
Last Update Posted : September 30, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infections
Acquired Immunodeficiency Syndrome
Interventions Drug: Atazanavir (ATV) 300 mg
Drug: Atazanavir (ATV) 400 mg
Drug: Ritonavir (rtv) 100 mg
Drug: Nucleo(side)/(tide) reverse transcriptase inhibitors (NRTIs)
Drug: Etravirine (ETR) 200 mg
Drug: Tenofovir disoproxil fumarate (TDF) 300 mg
Enrollment 50
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 25 25
Completed 15 16
Not Completed 10 9
Reason Not Completed
Adverse Event             2             1
Lost to Follow-up             3             2
Withdrawal by Subject             3             2
Subject noncompliant             1             3
Not specified             1             1
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
1
   4.0%
1
   2.0%
Between 18 and 65 years
25
 100.0%
24
  96.0%
49
  98.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
41.2  (10.44) 39.8  (9.37) 40.5  (9.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
12
  48.0%
13
  52.0%
25
  50.0%
Male
13
  52.0%
12
  48.0%
25
  50.0%
1.Primary Outcome
Title Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)
Hide Description 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).
Time Frame Day -1 (Pretreatment); Week 2 (Test)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ATV/Rtv 300/100 mg (Reference) ATV/Rtv 300/100 mg (Test)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: ng/ml
C0h, ng/ml (Reference, n=21; Test, n=19) 1339  (1728) 845.7  (703.3)
Cmin, ng/ml (Reference, n=20; Test, n=18) 1104  (1511) 758.6  (610.5)
Cmax, ng/ml (Reference, n=20; Test, n=19) 5652  (2735) 5232  (2166)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ATV/Rtv 300/100 mg (Reference), ATV/Rtv 300/100 mg (Test)
Comments Parameter: minimum plasma concentration (Cmin)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear mixed effects model
Comments A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.
Method of Estimation Estimation Parameter Least Squares (LS) Means Ratio
Estimated Value 0.82
Confidence Interval (2-Sided) 90%
0.55 to 1.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ATV/Rtv 300/100 mg (Reference), ATV/Rtv 300/100 mg (Test)
Comments Parameter: maximum plasma concentration (Cmax)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear mixed effects model
Comments A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.
Method of Estimation Estimation Parameter Least Squares (LS) Mean Ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 90%
0.80 to 1.16
Estimation Comments [Not Specified]
2.Primary Outcome
Title Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for AUC24hr)
Hide Description 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).
Time Frame Day -1 (Pretreatment); Week 2 (Test)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ATV/Rtv 300/100 mg (Reference) ATV/Rtv 300/100 mg (Test)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
60030  (39690) 55070  (21860)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ATV/Rtv 300/100 mg (Reference), ATV/Rtv 300/100 mg (Test)
Comments Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear mixed effects model
Comments linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.
Method of Estimation Estimation Parameter Least Squares (LS) Means Ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 90%
0.76 to 1.22
Estimation Comments [Not Specified]
3.Primary Outcome
Title Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)
Hide Description 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).
Time Frame Day -1 (Reference); Week 2 (Test)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title ATV/Rtv 300/100 mg (Reference) ATV/Rtv 400/100 mg (Test)
Hide Arm/Group Description:
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.
Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
Overall Number of Participants Analyzed 21 20
Mean (Standard Deviation)
Unit of Measure: ng/ml
C0h, ng/ml (Reference, n=22; Test, n=20) 1898  (2298) 1545  (1296)
Cmin, ng/ml (Reference, n=21;Test, n=18) 1671  (2310) 1107  (866.8)
Cmax, ng/ml (Reference, n=22; Test, n=20) 6419  (2853) 6950  (2693)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ATV/Rtv 300/100 mg (Reference), ATV/Rtv 400/100 mg (Test)
Comments Parameter: Minimum plasma concentration (Cmin)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear mixed effects model
Comments A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.
Method of Estimation Estimation Parameter Least Squares (LS) Means Ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 90%
0.63 to 1.33
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ATV/Rtv 300/100 mg (Reference), ATV/Rtv 400/100 mg (Test)
Comments Parameter: maximum plasma concentration (Cmax)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Linear mixed effects model
Comments A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.
Method of Estimation Estimation Parameter Least Squares (LS) Means Ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 90%
0.86 to 1.27
Estimation Comments [Not Specified]
4.Primary Outcome
Title Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for AUC24hr)
Hide Description 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).
Time Frame Day -1 (Reference); Week 2 (Test)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ATV/Rtv 300/100 mg (Reference) ATV/Rtv 300/100 mg (Test)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
74210  (55480) 72220  (34600)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ATV/Rtv 300/100 mg (Reference), ATV/Rtv 300/100 mg (Test)
Comments Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Llinear mixed effects model
Comments A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.
Method of Estimation Estimation Parameter Least Squares (LS) Means Ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 90%
0.81 to 1.21
Estimation Comments [Not Specified]
5.Primary Outcome
Title Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)
Hide Description 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).
Time Frame Day -1 (Reference); Week 2 (Test)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ATV/Rtv 300/100 mg (Reference) ATV/Rtv 300/100 mg (Test)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: ng/ml
C0h, ng/ml (Reference, n=21; Test, n=19) 143.4  (269.8) 102.5  (157.2)
Cmin, ng/ml (Reference, n=20; Test, n=18) 60.42  (73.17) 43.97  (36.29)
Cmax, ng/ml (Reference, n=20; Test, n=19) 1834  (1009) 1740  (1149)
6.Primary Outcome
Title Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for AUC24hr)
Hide Description 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).
Time Frame Day -1 (Reference); Week 2 (Test)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ATV/Rtv 300/100 mg (Reference) ATV/Rtv 300/100 mg (Test)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: ng.h/ml
12560  (6643) 11120  (6658)
7.Primary Outcome
Title Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)
Hide Description 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).
Time Frame Day -1 (Reference); Week 2 (Test)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ATV/Rtv 300/100 mg (Reference) ATV/Rtv 400/100 mg (Test)
Hide Arm/Group Description:
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.
Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks (Day 1 to Week 48). Pharmacokinetic results for rtv provided in the table below are at Week 2.
Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: ng/ml
C0h, ng/ml (Reference, n=22; Test, n=20) 109.2  (94.50) 163.4  (240.2)
Cmin, ng/ml 64.70  (51.80) 75.68  (69.98)
Cmax, ng/ml (Reference, n=22) 1882  (1026) 1847  (859.9)
8.Primary Outcome
Title Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for AUC24hr)
Hide Description 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).
Time Frame Day -1 (Reference); Week 2 (Test)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ATV/Rtv 300/100 mg (Reference) ATV/Rtv 300/100 mg (Test)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: ng.h/ml
13880  (8198) 13660  (6778)
9.Primary Outcome
Title Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)
Hide Description 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).
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Hide Arm/Group Description:
Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: ng/ml
C0h (Treatment B, n=19) 422.2  (327.9) 316.6  (215.4)
Cmin (Treatment A, n=16; Treatment B, n=18) 425.1  (328.1) 286.5  (198.0)
Cmax (Treatment A, n=18; Treatment B, n=18) 773.0  (360.5) 628.7  (294.0)
10.Primary Outcome
Title Pharmacokinetic Results of Etravirine (ETR) (Results for AUC12hr)
Hide Description 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).
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Hide Arm/Group Description:
Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
7629  (4213) 5171  (2695)
11.Primary Outcome
Title Percentage of Participants With Undetectable Plasma Viral Load (VL) Values (<50 Copies/mL) at Week 48
Hide Description 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).
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Hide Arm/Group Description:
Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
50.0
(28.2 to 71.8)
45.5
(45.5 to 67.8)
12.Secondary Outcome
Title Change From Prebaseline in CD4+ Cell Count Over Time
Hide Description The table below shows the mean change from prebaseline over time in CD4+ cell count using the Non-Completing = Failure (NC=F) imputation method.
Time Frame Prebaseline, Baseline, Weeks 4, 12, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Hide Arm/Group Description:
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: CD4+ cell count
Baseline 16  (11.8) 8  (18)
Week 4 55  (15.4) 46  (27.4)
Week 12 31  (15.0) 72  (23.5)
Week 24 54  (22.0) 83  (23.2)
Week 48 105  (31.1) 132  (32.6)
13.Secondary Outcome
Title The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
Hide Description 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).
Time Frame Baseline, Weeks 4, 12, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Hide Arm/Group Description:
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: Percentage of Participants
<50 copies/mL, Baseline 9.1 9.1
<50 copies/mL, Week 4 31.8 36.4
<50 copies/mL, Week 12 59.1 59.1
<50 copies/mL, Week 24 63.6 63.6
<50 copies/mL, Week 48 50.0 45.5
<400 copies/mL, Baseline 40.9 40.9
<400 copies/mL, Week 4 77.3 77.3
<400 copies/mL, Week 12 68.2 81.8
<400 copies/mL, Week 24 72.7 72.7
<400 copies/mL, Week 48 50.0 59.1
14.Secondary Outcome
Title The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
Hide Description 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.
Time Frame Baseline, Weeks 4, 12, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment A)
Hide Arm/Group Description:
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: Percentage of Particpants
<50 copies/mL, Baseline 9.1 4.5
<50 copies/mL, Week 4 31.8 36.4
<50 copies/mL, Week 12 59.1 54.5
<50 copies/mL, Week 24 63.6 59.1
<50 copies/mL, Week 48 45.5 50.0
<400 copies/mL, Baseline 36.4 40.9
<400 copies/mL, Week 4 77.3 77.3
<400 copies/mL, Week 12 68.2 86.4
<400 copies/mL, Week 24 68.2 68.2
<400 copies/mL, Week 48 59.1 54.5
15.Secondary Outcome
Title The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method
Hide Description 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.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Hide Arm/Group Description:
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: Percentage of Participants
Virologic Response 50.0 45.5
Virologic Failure 31.8 36.4
No VL Data Available 18.2 18.2
16.Secondary Outcome
Title Change From Pre-Baseline in Log10 Viral Load Over Time
Hide Description 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.
Time Frame Pre-Baseline, Baseline, Weeks 4, 12, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Hide Arm/Group Description:
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: log10 (Copies/mL)
Baseline -1.4  (0.14) -1.4  (0.18)
Week 4 -1.9  (0.18) -1.8  (0.15)
Week 12 -1.7  (0.26) -2.0  (0.23)
Week 24 -1.8  (0.24) -1.8  (0.27)
Week 48 -1.4  (0.24) -1.4  (0.29)
17.Secondary Outcome
Title Time to Confirmed Virologic Response
Hide Description 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.
Time Frame Prebaseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Hide Arm/Group Description:
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
Overall Number of Participants Analyzed 22 22
Median (95% Confidence Interval)
Unit of Measure: Days
Plasma VL < 50 copies/mL
71.0
(44.0 to 129.0)
76.0
(42.0 to 99.0)
Plasma VL < 400 copies/mL
28.0
(15.0 to 43.0)
28.0
(15.0 to 43.0)
18.Secondary Outcome
Title Time to Virologic Failure
Hide Description 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.
Time Frame Prebaseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Hide Arm/Group Description:
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
Treatment-experienced 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 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
Overall Number of Participants Analyzed 22 22
Median (95% Confidence Interval)
Unit of Measure: Days
Virologic Responders (Plasma VL < 50 copies/mL)
318.0 [1] 
(78.0 to NA)
NA [2] 
(NA to NA)
Virologic Responders (Plasma VL < 400 copies/mL)
NA [3] 
(NA to NA)
NA [3] 
(NA to NA)
[1]
The upper limit of the 95% CI could not be assessed because a sufficient number of participants did not experience virologic failure.
[2]
Median cannot be assessed since less than 50% of participants experienced virologic failure.
[3]
Median cannot be assessed since less than 50% of participants experienced virologic failure
Time Frame Up to a maximum of 56 weeks.
Adverse Event Reporting Description 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').
 
Arm/Group Title ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/25 (16.00%)   2/25 (8.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/25 (4.00%)  0/25 (0.00%) 
Infections and infestations     
Gastroenteritis * 1  1/25 (4.00%)  0/25 (0.00%) 
Meningitis aseptic * 1  1/25 (4.00%)  0/25 (0.00%) 
Pneumonia * 1  1/25 (4.00%)  1/25 (4.00%) 
Sinusitis * 1  1/25 (4.00%)  0/25 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose * 1  1/25 (4.00%)  0/25 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bowen's disease * 1  0/25 (0.00%)  1/25 (4.00%) 
Metastatic malignant melanoma * 1  1/25 (4.00%)  0/25 (0.00%) 
Nervous system disorders     
Headache * 1  0/25 (0.00%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/25 (4.00%)  0/25 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ATV/Rtv 300/100 mg (Treatment A) ATV/Rtv 400/100 mg (Treatment B)
Affected / at Risk (%) Affected / at Risk (%)
Total   21/25 (84.00%)   15/25 (60.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/25 (0.00%)  2/25 (8.00%) 
Diarrhoea * 1  2/25 (8.00%)  2/25 (8.00%) 
Nausea * 1  4/25 (16.00%)  1/25 (4.00%) 
Vomiting * 1  2/25 (8.00%)  0/25 (0.00%) 
General disorders     
Fatigue * 1  2/25 (8.00%)  1/25 (4.00%) 
Pyrexia * 1  2/25 (8.00%)  0/25 (0.00%) 
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  3/25 (12.00%)  0/25 (0.00%) 
Jaundice * 1  2/25 (8.00%)  2/25 (8.00%) 
Infections and infestations     
Bronchitis * 1  2/25 (8.00%)  1/25 (4.00%) 
Influenza * 1  2/25 (8.00%)  3/25 (12.00%) 
Sinusitis * 1  2/25 (8.00%)  0/25 (0.00%) 
Upper respiratory tract infection * 1  2/25 (8.00%)  3/25 (12.00%) 
Investigations     
Blood bilirubin increased * 1  3/25 (12.00%)  2/25 (8.00%) 
Nervous system disorders     
Headache * 1  3/25 (12.00%)  3/25 (12.00%) 
Neuropathy peripheral * 1  2/25 (8.00%)  0/25 (0.00%) 
Psychiatric disorders     
Anxiety disorder * 1  2/25 (8.00%)  0/25 (0.00%) 
Depression * 1  2/25 (8.00%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  5/25 (20.00%)  4/25 (16.00%) 
Oropharyngeal pain * 1  2/25 (8.00%)  1/25 (4.00%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  0/25 (0.00%)  2/25 (8.00%) 
Rash * 1  3/25 (12.00%)  1/25 (4.00%) 
Rash maculo-papular * 1  1/25 (4.00%)  2/25 (8.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Director
Organization: Tibotec
Phone: +32 (0) 14 641 265
Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT00896051     History of Changes
Other Study ID Numbers: CR016045
TMC125-TiDP2-C238 ( Other Identifier: Janssen R&D Ireland )
First Submitted: May 7, 2009
First Posted: May 11, 2009
Results First Submitted: April 10, 2013
Results First Posted: September 30, 2013
Last Update Posted: September 30, 2013