ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00823979
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : January 16, 2009
Results First Posted : March 14, 2014
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition HIV-1
Interventions Drug: UK-453,061 Dose 1
Drug: UK-453,061 Dose 2
Drug: Etravirine
Enrollment 105
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily. Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily. Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Period Title: Overall Study
Started 35 35 35
Treated 31 32 34
Completed 6 3 11
Not Completed 29 32 24
Reason Not Completed
Lack of Efficacy             13             16             9
Lost to Follow-up             2             1             0
Withdrawal by Subject             2             3             2
Protocol Violation             1             1             0
Pregnancy             0             1             0
Adverse Event             0             2             4
Other             2             0             1
Randomized but not Treated             4             3             1
Study Terminated by Sponsor             5             5             7
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg Total
Hide Arm/Group Description Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily. Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily. Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily. Total of all reporting groups
Overall Number of Baseline Participants 31 32 34 97
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) population included all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 32 participants 34 participants 97 participants
41.1  (8.9) 40.0  (8.7) 41.9  (9.1) 41.0  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 34 participants 97 participants
Female
15
  48.4%
18
  56.3%
18
  52.9%
51
  52.6%
Male
16
  51.6%
14
  43.8%
16
  47.1%
46
  47.4%
1.Primary Outcome
Title Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24
Hide Description Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants who died, discontinued, lost to follow-up, switched/changed dose of anti-retro viral (ARV) drug not allowed by protocol, had missing plasma HIV-1 RNA data at 24 weeks were considered to have plasma HIV-1 RNA >=50 copies/mL and were referred to as failure.
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description:
Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Overall Number of Participants Analyzed 31 32 34
Measure Type: Number
Unit of Measure: percentage of participants
48.4 43.8 67.6
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96
Hide Description Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).
Time Frame Weeks 48, 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants who died, discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 48, 96 weeks were considered to have plasma HIV-1 RNA >=50 copies/mL and were referred to as failure. n=participants evaluable at specified time point for each arm group, respectively.
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description:
Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Overall Number of Participants Analyzed 31 32 34
Measure Type: Number
Unit of Measure: percentage of participants
Week 48 (n=31, 32, 34) 41.9 31.3 61.8
Week 96 (n=28, 28, 27) 25.0 14.3 37.0
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96
Hide Description Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).
Time Frame Week 24, 48, 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants who died,discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 24, 48, 96 weeks were considered to have plasma HIV-1 RNA >=400 copies/mL and referred to as failure. n=participants evaluable at specified time point for each arm group, respectively.
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description:
Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Overall Number of Participants Analyzed 31 32 34
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 (n=31, 32, 34) 54.8 50.0 79.4
Week 48 (n=31, 32, 34) 41.9 34.4 70.6
Week 96 (n=28, 28, 27) 25.0 14.3 37.0
4.Secondary Outcome
Title Change From Baseline in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96
Hide Description Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5). For the log10 scale, all the HIV-1 RNA levels were log10 transformed prior to the average calculations. Baseline value calculated as average of measurements collected prior to and including Day 1 pre-dose.
Time Frame Baseline, Week 24, 48, 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation is missing: last observation carried forward (LOCF) imputation used; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description:
Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Overall Number of Participants Analyzed 31 32 34
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
Baseline 4.28  (0.99) 4.76  (0.82) 4.59  (0.79)
Change at Week 24 -1.53  (1.58) -1.89  (1.46) -2.32  (1.21)
Change at Week 48 -1.30  (1.64) -1.08  (1.48) -2.06  (1.42)
Change at Week 96 -0.69  (1.39) -0.36  (1.00) -0.96  (1.49)
5.Secondary Outcome
Title Time-Averaged Difference (TAD) in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96
Hide Description TAD was calculated as (area under the curve of HIV-1 RNA levels [log10 copies/mL] from baseline to the time point of interest divided by time period in weeks) minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value calculated as average of measurements collected at prior to and including Day 1 pre-dose. Due to early termination of the study decision was made not to derive TAD results for Week 96.
Time Frame Week 24, 48, 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participant discontinued before a visit of interest: TAD imputed as zero; not discontinued but observation was missing at visit: TAD to the last non-missing timepoint; not discontinued and missing values between baseline and visit: ignore missing values; missing baseline or no HIV-1 RNA level assessment: TAD imputed as zero.
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description:
Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Overall Number of Participants Analyzed 31 32 34
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
Week 24 -1.46  (1.12) -1.72  (1.11) -2.10  (0.92)
Week 48 -1.28  (1.39) -1.19  (1.35) -1.89  (1.27)
6.Secondary Outcome
Title Percentage of Participants With Response as Determined by the Time to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96
Hide Description TLOVR50 response (50 denotes lower limit of quantification [LLOQ] of assay=50 copies/mL): compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; new ARV drug; met treatment failure [TF] criteria). TF: an increase of at least (>=)3 times the baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level <50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (>50 copies/mL); HIV-1 RNA <1 log10 decrease from baseline at Week 4 or thereafter. TF were confirmed by second measurement >=14 days after first. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.
Time Frame Week 24, 48, 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT.Participants who died,discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 24,48 weeks were considered to have plasma HIV-1 RNA>=50 copies/mL;were referred as failure. Due to early termination of study,decision was made not to derive TLOVR50 responder analysis for Week 96.
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description:
Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Overall Number of Participants Analyzed 31 32 34
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 48.4 43.8 67.6
Week 48 41.9 28.1 55.9
7.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4 (CD4+) Absolute Lymphocyte Counts at Week 24, 48 and 96
Hide Description Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.
Time Frame Baseline, Week 24, 48, 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug. Missing values were imputed using LOCF. Participants with missing baseline or no CD4+ count available on treatment imputed as no or zero change from baseline.
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description:
Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Overall Number of Participants Analyzed 31 32 34
Mean (Standard Deviation)
Unit of Measure: cells per microliter (cells/mcL)
Baseline 247  (143) 259  (187) 227  (146)
Change at Week 24 98  (140) 66  (111) 110  (108)
Change at Week 48 122  (148) 74  (128) 128  (127)
Change at Week 96 148  (177) 89  (152) 184  (197)
8.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4 (CD4+) Percentage Lymphocyte Counts at Week 24, 48, 96
Hide Description Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.
Time Frame Baseline, Week 24, 48, 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study drug. Missing values were imputed using LOCF. Participants with missing baseline or no CD4+ count available on treatment imputed as no or zero change from baseline.
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description:
Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Overall Number of Participants Analyzed 31 32 34
Mean (Standard Deviation)
Unit of Measure: percentage of total lymphocytes
Baseline 16.1  (8.7) 15.0  (8.8) 14.6  (8.3)
Change at Week 24 3.0  (4.0) 3.7  (3.6) 3.7  (3.2)
Change at Week 48 4.6  (5.3) 4.0  (4.1) 4.4  (3.8)
Change at Week 96 5.4  (6.1) 4.2  (4.9) 6.2  (6.2)
9.Secondary Outcome
Title Number of Participants With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Resistance-Associated Mutations (RAMs) and/or Phenotypic Susceptibility at Time of Treatment Failure Through Week 48
Hide Description Genotypic and phenotypic resistance to NNRTIs based on International Acquired Immunodeficiency Syndrome (AIDS) Society, United States of America (IAS-USA) RAM guidelines were evaluated using Monogram Biosciences PhenoSenseGT Assay at Baseline. This was then repeated for all participants with HIV-1 viral load >500 copies/mL at treatment failure, up to Week 48.
Time Frame Baseline through Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Virology analysis set included a subset of participants from TLOVR50 failures who had valid genotypic or phenotypic susceptibility testing result and with plasma HIV-1 RNA >500 copies/mL at baseline and treatment failure.
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description:
Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Overall Number of Participants Analyzed 12 16 4
Measure Type: Number
Unit of Measure: participants
5 3 1
10.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities
Hide Description Laboratory analysis included blood chemistry, hematology and urinalysis.
Time Frame Baseline up to Week 48 or early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description:
Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Overall Number of Participants Analyzed 29 31 34
Measure Type: Number
Unit of Measure: participants
27 30 33
11.Secondary Outcome
Title Population Pharmacokinetics (PK) of Lersivirine
Hide Description Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Time Frame Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)
Hide Description Simple quartile exposure analysis of success rate (viral load <50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level <50 copies/mL at median Cmin quartile were planned to be reported.
Time Frame Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the sparsity of the data, the ability to interpret the pharmacokinetic/pharmacodynamic (PK/PD) results was limited, thus the data was not reported.
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description:
Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Hide Arm/Group Description Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily. Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily. Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
All-Cause Mortality
Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/31 (3.23%)   4/32 (12.50%)   1/34 (2.94%) 
Cardiac disorders       
Coronary artery disease * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Infections and infestations       
Pneumocystis jiroveci pneumonia * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Pneumonia * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Pulmonary tuberculosis * 1  0/31 (0.00%)  2/32 (6.25%)  0/34 (0.00%) 
Injury, poisoning and procedural complications       
Head injury * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Vascular disorders       
Hypertension * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lersivirine 750 mg Lersivirine 1000 mg Etravirine 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   27/31 (87.10%)   25/32 (78.13%)   32/34 (94.12%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/31 (3.23%)  1/32 (3.13%)  0/34 (0.00%) 
Lymphadenopathy * 1  0/31 (0.00%)  0/32 (0.00%)  2/34 (5.88%) 
Polycythaemia * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Thrombocytopenia * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Cardiac disorders       
Coronary artery disease * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Palpitations * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Sinus bradycardia * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Ear and labyrinth disorders       
Ear pain * 1  0/31 (0.00%)  2/32 (6.25%)  0/34 (0.00%) 
Hearing impaired * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Endocrine disorders       
Hypothyroidism * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Eye disorders       
Conjunctival haemorrhage * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Conjunctivitis * 1  1/31 (3.23%)  0/32 (0.00%)  1/34 (2.94%) 
Conjunctivitis allergic * 1  1/31 (3.23%)  0/32 (0.00%)  1/34 (2.94%) 
Uveitis * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Visual acuity reduced * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Abdominal distension * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Abdominal pain * 1  1/31 (3.23%)  0/32 (0.00%)  1/34 (2.94%) 
Abdominal pain upper * 1  1/31 (3.23%)  3/32 (9.38%)  3/34 (8.82%) 
Cheilitis * 1  1/31 (3.23%)  0/32 (0.00%)  1/34 (2.94%) 
Constipation * 1  1/31 (3.23%)  0/32 (0.00%)  1/34 (2.94%) 
Dental caries * 1  0/31 (0.00%)  1/32 (3.13%)  1/34 (2.94%) 
Diarrhoea * 1  8/31 (25.81%)  7/32 (21.88%)  6/34 (17.65%) 
Dry mouth * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Dyspepsia * 1  1/31 (3.23%)  2/32 (6.25%)  1/34 (2.94%) 
Faeces hard * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Flatulence * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Gastritis * 1  1/31 (3.23%)  1/32 (3.13%)  0/34 (0.00%) 
Gastrooesophageal reflux disease * 1  1/31 (3.23%)  1/32 (3.13%)  1/34 (2.94%) 
Glossodynia * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Haematemesis * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Haemorrhoids * 1  1/31 (3.23%)  0/32 (0.00%)  1/34 (2.94%) 
Mouth ulceration * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Nausea * 1  8/31 (25.81%)  14/32 (43.75%)  4/34 (11.76%) 
Oesophagitis * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Oral disorder * 1  1/31 (3.23%)  1/32 (3.13%)  0/34 (0.00%) 
Rectal haemorrhage * 1  1/31 (3.23%)  0/32 (0.00%)  1/34 (2.94%) 
Salivary hypersecretion * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Vomiting * 1  6/31 (19.35%)  3/32 (9.38%)  3/34 (8.82%) 
General disorders       
Asthenia * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Fat tissue increased * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Fatigue * 1  0/31 (0.00%)  2/32 (6.25%)  0/34 (0.00%) 
Gait disturbance * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Pain * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Hepatobiliary disorders       
Hepatitis toxic * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Immune system disorders       
Hypersensitivity * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Infections and infestations       
Abscess neck * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Acarodermatitis * 1  1/31 (3.23%)  1/32 (3.13%)  0/34 (0.00%) 
Acute sinusitis * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Asymptomatic bacteriuria * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Body tinea * 1  2/31 (6.45%)  1/32 (3.13%)  0/34 (0.00%) 
Bronchitis * 1  2/31 (6.45%)  1/32 (3.13%)  1/34 (2.94%) 
Carbuncle * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Cellulitis * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Cystitis * 1  0/31 (0.00%)  0/32 (0.00%)  2/34 (5.88%) 
Dermatophytosis * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Folliculitis * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Furuncle * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Gastroenteritis * 1  0/31 (0.00%)  1/32 (3.13%)  2/34 (5.88%) 
Gastroenteritis viral * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Gingivitis * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Hepatitis B * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Herpes simplex * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Herpes zoster * 1  0/31 (0.00%)  0/32 (0.00%)  5/34 (14.71%) 
Hordeolum * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Influenza * 1  4/31 (12.90%)  0/32 (0.00%)  4/34 (11.76%) 
Labyrinthitis * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Lower respiratory tract infection * 1  0/31 (0.00%)  0/32 (0.00%)  2/34 (5.88%) 
Myringitis * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Nasopharyngitis * 1  2/31 (6.45%)  2/32 (6.25%)  0/34 (0.00%) 
Onychomycosis * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Oral hairy leukoplakia * 1  0/31 (0.00%)  1/32 (3.13%)  1/34 (2.94%) 
Otitis media * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Papilloma viral infection * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Paronychia * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Pharyngitis * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Respiratory tract infection * 1  1/31 (3.23%)  0/32 (0.00%)  1/34 (2.94%) 
Respiratory tract infection viral * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Rhinitis * 1  0/31 (0.00%)  0/32 (0.00%)  2/34 (5.88%) 
Sinusitis * 1  2/31 (6.45%)  2/32 (6.25%)  0/34 (0.00%) 
Tinea cruris * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Tinea pedis * 1  1/31 (3.23%)  1/32 (3.13%)  1/34 (2.94%) 
Tonsillitis * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Tooth abscess * 1  0/31 (0.00%)  0/32 (0.00%)  2/34 (5.88%) 
Trichomoniasis * 1  1/31 (3.23%)  1/32 (3.13%)  0/34 (0.00%) 
Upper respiratory tract infection * 1  3/31 (9.68%)  3/32 (9.38%)  5/34 (14.71%) 
Urinary tract infection * 1  0/31 (0.00%)  3/32 (9.38%)  3/34 (8.82%) 
Vaginal infection * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Viral upper respiratory tract infection * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Vulvovaginal candidiasis * 1  2/31 (6.45%)  0/32 (0.00%)  0/34 (0.00%) 
Injury, poisoning and procedural complications       
Excoriation * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Muscle strain * 1  0/31 (0.00%)  1/32 (3.13%)  1/34 (2.94%) 
Radiation associated pain * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Soft tissue injury * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Wrist fracture * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Investigations       
Blood cholesterol increased * 1  0/31 (0.00%)  1/32 (3.13%)  1/34 (2.94%) 
Blood creatine phosphokinase increased * 1  1/31 (3.23%)  0/32 (0.00%)  1/34 (2.94%) 
Blood glucose increased * 1  1/31 (3.23%)  1/32 (3.13%)  2/34 (5.88%) 
Blood thyroid stimulating hormone increased * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Blood triglycerides increased * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Gamma-glutamyltransferase increased * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Hepatic enzyme abnormal * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Hepatic enzyme increased * 1  1/31 (3.23%)  0/32 (0.00%)  1/34 (2.94%) 
Low density lipoprotein increased * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Tetrahydrocortisol urine increased * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Urine leukocyte esterase positive * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Diabetes mellitus * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Dyslipidaemia * 1  1/31 (3.23%)  0/32 (0.00%)  2/34 (5.88%) 
Glucose tolerance impaired * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Hypertriglyceridaemia * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Hyperuricaemia * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Impaired fasting glucose * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Type 2 diabetes mellitus * 1  0/31 (0.00%)  1/32 (3.13%)  1/34 (2.94%) 
Vitamin D deficiency * 1  0/31 (0.00%)  1/32 (3.13%)  1/34 (2.94%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  2/31 (6.45%)  1/32 (3.13%)  1/34 (2.94%) 
Back pain * 1  2/31 (6.45%)  0/32 (0.00%)  5/34 (14.71%) 
Intervertebral disc degeneration * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Joint range of motion decreased * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Joint swelling * 1  1/31 (3.23%)  1/32 (3.13%)  0/34 (0.00%) 
Monarthritis * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Muscle spasms * 1  0/31 (0.00%)  2/32 (6.25%)  0/34 (0.00%) 
Musculoskeletal pain * 1  1/31 (3.23%)  1/32 (3.13%)  1/34 (2.94%) 
Myalgia * 1  0/31 (0.00%)  0/32 (0.00%)  2/34 (5.88%) 
Neck pain * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Pain in extremity * 1  0/31 (0.00%)  0/32 (0.00%)  3/34 (8.82%) 
Pain in jaw * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Tendonitis * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Nervous system disorders       
Aphasia * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Burning sensation * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Convulsion * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Disturbance in attention * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Dizziness * 1  2/31 (6.45%)  2/32 (6.25%)  1/34 (2.94%) 
Headache * 1  2/31 (6.45%)  2/32 (6.25%)  4/34 (11.76%) 
Hemiparesis * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Hemiplegia * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Hypersomnia * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Hypoaesthesia * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Hypogeusia * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Memory impairment * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Muscle spasticity * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Neuropathy peripheral * 1  0/31 (0.00%)  1/32 (3.13%)  1/34 (2.94%) 
Paraesthesia * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Somnolence * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
VIIth nerve paralysis * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Vasogenic cerebral oedema * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Psychiatric disorders       
Anxiety * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Depressed mood * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Depression * 1  0/31 (0.00%)  0/32 (0.00%)  3/34 (8.82%) 
Insomnia * 1  2/31 (6.45%)  0/32 (0.00%)  1/34 (2.94%) 
Nightmare * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Renal and urinary disorders       
Proteinuria * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Renal failure acute * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Reproductive system and breast disorders       
Cervical dysplasia * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Menorrhagia * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Bronchospasm * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Cough * 1  2/31 (6.45%)  0/32 (0.00%)  0/34 (0.00%) 
Epistaxis * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Lung cyst * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Nasal congestion * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Oropharyngeal pain * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Pleural effusion * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Productive cough * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Rhinitis allergic * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Rhinorrhoea * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Sinus congestion * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Upper-airway cough syndrome * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis * 1  1/31 (3.23%)  0/32 (0.00%)  1/34 (2.94%) 
Dermatitis allergic * 1  1/31 (3.23%)  1/32 (3.13%)  0/34 (0.00%) 
Dry skin * 1  1/31 (3.23%)  1/32 (3.13%)  0/34 (0.00%) 
Dyshidrosis * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Eczema * 1  0/31 (0.00%)  2/32 (6.25%)  0/34 (0.00%) 
Ingrowing nail * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Intertrigo * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Lipodystrophy acquired * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Prurigo * 1  1/31 (3.23%)  0/32 (0.00%)  0/34 (0.00%) 
Pruritus * 1  2/31 (6.45%)  2/32 (6.25%)  1/34 (2.94%) 
Psoriasis * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Rash * 1  0/31 (0.00%)  0/32 (0.00%)  5/34 (14.71%) 
Rash erythematous * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Rash maculo-papular * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Rash papular * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Scar * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Seborrhoeic dermatitis * 1  2/31 (6.45%)  1/32 (3.13%)  0/34 (0.00%) 
Skin hypopigmentation * 1  0/31 (0.00%)  0/32 (0.00%)  1/34 (2.94%) 
Skin lesion * 1  0/31 (0.00%)  2/32 (6.25%)  1/34 (2.94%) 
Vascular disorders       
Arterial spasm * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Hypertension * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Hypertensive crisis * 1  0/31 (0.00%)  1/32 (3.13%)  0/34 (0.00%) 
Hypotension * 1  1/31 (3.23%)  0/32 (0.00%)  1/34 (2.94%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v15.1
The trial was terminated on 12 April, 2012 due to lack of efficacy at the Week 24 analysis. The decision to terminate the trial was not based on any safety concerns.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00823979     History of Changes
Other Study ID Numbers: A5271022
2007-004392-19 ( EudraCT Number )
First Submitted: January 15, 2009
First Posted: January 16, 2009
Results First Submitted: January 28, 2014
Results First Posted: March 14, 2014
Last Update Posted: December 4, 2018