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A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1

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ClinicalTrials.gov Identifier: NCT00824421
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : January 24, 2014
Last Update Posted : January 24, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV-1
Interventions Drug: UK-453, 061
Drug: EFV +TVA
Enrollment 195

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96. Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96. Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Period Title: Overall Study
Started 66 66 63
Treated 65 65 63
Completed 49 44 49
Not Completed 17 22 14
Reason Not Completed
Adverse Event             6             6             6
Death             0             1             0
Lack of Efficacy             5             7             4
Lost to Follow-up             2             3             0
Pregnancy             1             0             1
Withdrawal by Subject             2             3             3
Randomized but not Treated             1             1             0
Other             0             1             0
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg Total
Hide Arm/Group Description Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96. Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96. Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96. Total of all reporting groups
Overall Number of Baseline Participants 65 65 63 193
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants who had received at least 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 65 participants 63 participants 193 participants
36.5  (8.0) 35.7  (8.2) 36.3  (8.7) 36.2  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 65 participants 63 participants 193 participants
Female
16
  24.6%
19
  29.2%
17
  27.0%
52
  26.9%
Male
49
  75.4%
46
  70.8%
46
  73.0%
141
  73.1%
1.Primary Outcome
Title Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48
Hide Description Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.
Time Frame Week 48
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 medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=50 copies/mL and were referred to as non-completer = failure.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description:
Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Overall Number of Participants Analyzed 65 65 63
Measure Type: Number
Unit of Measure: percentage of participants
78.5 78.5 85.7
2.Secondary Outcome
Title Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96
Hide Description Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.
Time Frame Week 24, 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 medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=50 copies/mL and were referred to as non-completer = failure.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description:
Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Overall Number of Participants Analyzed 65 65 63
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 83.1 83.1 87.3
Week 96 70.8 67.7 77.8
3.Secondary Outcome
Title Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96
Hide Description Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.
Time Frame 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 medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=400 copies/mL and were referred to as non-completer = failure.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description:
Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Overall Number of Participants Analyzed 65 65 63
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 84.6 87.7 90.5
Week 48 81.5 80.0 85.7
Week 96 73.8 67.7 77.8
4.Secondary Outcome
Title Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96
Hide Description For the log 10 scale, all the HIV-1 RNA levels were log 10 transformed prior to the average calculations. Baseline value was calculated as the average of all 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. 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 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description:
Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Overall Number of Participants Analyzed 65 65 63
Mean (Standard Deviation)
Unit of Measure: log 10 copies/mL
Baseline 4.62  (0.61) 4.69  (0.66) 4.66  (0.62)
Change at Week 24 -2.44  (1.19) -2.63  (1.11) -2.68  (1.05)
Change at Week 48 -2.36  (1.26) -2.34  (1.33) -2.52  (1.17)
Change at Week 96 -2.19  (1.38) -1.98  (1.48) -2.27  (1.34)
5.Secondary Outcome
Title Time-Averaged Difference (TAD) in Log 10 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 was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.
Time Frame Baseline up to 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 was missing: value calculated 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: value imputed as zero.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description:
Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Overall Number of Participants Analyzed 65 65 63
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
Week 24 -2.17  (0.99) -2.30  (0.94) -2.40  (0.89)
Week 48 -2.23  (1.17) -2.24  (1.19) -2.39  (1.09)
Week 96 -2.16  (1.33) -1.92  (1.43) -2.21  (1.29)
6.Secondary Outcome
Title Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96
Hide Description TLOVR50 response is 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; met treatment failure [TF] criteria). TF: an increase to at least 3 times 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). TF criteria’s defined above were confirmed by second measurement at least 14 days after first. In 'TLOVR50', '50' denotes the lower limit of quantification (LLOQ) of assay (which is 50 copies/mL). Baseline value was calculated as the average of all 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 population included all randomized participants who received at least 1 dose of study medication. Missing value was imputed per the TLOVR algorithm.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description:
Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Overall Number of Participants Analyzed 65 65 63
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 83.1 83.1 87.3
Week 48 78.5 78.5 85.7
Week 96 67.7 67.7 76.2
7.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation (CD4+) Absolute Cell Count at Week 24, 48 and 96
Hide Description Baseline value was calculated as the average of all 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 medication. LOCF method was used to impute missing values. No or zero change from baseline was imputed for participants with missing baseline or no CD4+ count available on treatment.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description:
Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Overall Number of Participants Analyzed 65 65 63
Mean (Standard Deviation)
Unit of Measure: cells per microliter (cells/mcL)
Baseline 349  (120) 352  (154) 319  (80)
Change at Week 24 146  (164) 167  (127) 139  (104)
Change at Week 48 191  (206) 195  (130) 188  (117)
Change at Week 96 215  (194) 231  (187) 221  (144)
8.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation (CD4+) Percentage Cell Count at Week 24, 48 and 96
Hide Description Baseline value was calculated as the average of all 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 medication. LOCF method was used to impute missing values. No or zero change from baseline was imputed for participants with missing baseline or no CD4+ count available on treatment.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description:
Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Overall Number of Participants Analyzed 65 65 63
Mean (Standard Deviation)
Unit of Measure: percentage of total lymphocytes
Baseline 19.9  (6.6) 20.0  (6.7) 19.5  (5.4)
Change at Week 24 6.0  (4.1) 7.5  (3.7) 7.3  (4.7)
Change at Week 48 8.3  (5.0) 9.9  (4.3) 8.7  (4.9)
Change at Week 96 10.1  (6.4) 12.1  (6.5) 11.1  (6.0)
9.Secondary Outcome
Title Number of Participants With NRTI and NNRTI Resistance-Associated Mutations (RAMs) at Time of Treatment Failure Through Week 24, 48 and 96
Hide Description Phenotypic resistance and genotypic resistance was assessed for all participants at Day 1 predose, and was evaluated for nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) resistance-associated mutations at time of treatment failure using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure, up to Week 96.
Time Frame Day 1 (pre-dose) through Week 24, 48, 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Virology analysis set (TLOVR50 failures) included all participants who meet the TLOVR50 failure definition. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point for each group, respectively.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description:
Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Overall Number of Participants Analyzed 5 8 6
Measure Type: Number
Unit of Measure: participants
Week 24 (n=3, 4, 2) 3 0 1
Week 48 (n=4, 3, 3) 3 1 1
Week 96 (n= 5, 8, 6) 3 1 1
10.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities
Hide Description Laboratory analysis included hematology, blood chemistry, serum and urine pregnancy test, hepatitis testing and urinalysis. Laboratory values that met the criteria of the Division of Acquired Immuno Deficiency Syndrome (DAIDS) grade 1 (mild, symptoms causing no or minimal interference with usual social and functional activities) or greater were considered as abnormal.
Time Frame Baseline up to Week 96 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 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description:
Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Overall Number of Participants Analyzed 64 65 63
Measure Type: Number
Unit of Measure: participants
59 58 57
11.Secondary Outcome
Title Population Pharmacokinetic (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 Week 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 Week 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, it was deemed that the interpretation of the pharmacokinetic/pharmacodynamic (PK/PD) results would be questionable, thus data was not analyzed.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description:
Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lersivirine
Hide Description AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0-24). Only participants from Lersivirine treatment arms were planned to be analyzed for Pharmacokinetic (PK) sub-study.
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hours (hrs) post-dose on Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic sub-study analysis set (PKSSAS) included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg
Hide Arm/Group Description:
Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
Overall Number of Participants Analyzed 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour/milliliter (ng*hr/mL)
6002
(30%)
8677
(21%)
14.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Lersivirine
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PKSSAS included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg
Hide Arm/Group Description:
Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
Overall Number of Participants Analyzed 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1056
(41%)
1354
(31%)
15.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lersivirine
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PKSSAS included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg
Hide Arm/Group Description:
Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
Overall Number of Participants Analyzed 7 6
Median (Full Range)
Unit of Measure: hr
1.00
(0.483 to 2.00)
2.00
(0.500 to 8.00)
16.Secondary Outcome
Title Plasma Concentration of Lersivirine at 24 Hour
Hide Description The observed plasma concentration at 24 hours post-dose (C 24h).
Time Frame 24 hrs post-dose on Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PKSSAS included all randomized Lersivirine participants who further consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg
Hide Arm/Group Description:
Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
Overall Number of Participants Analyzed 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
49.56
(73%)
57.70
(34%)
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 non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Hide Arm/Group Description Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96. Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96. Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
All-Cause Mortality
Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/65 (9.23%)   7/65 (10.77%)   6/63 (9.52%) 
Gastrointestinal disorders       
Rectal ulcer * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Immune system disorders       
Hypersensitivity * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Infections and infestations       
Bronchitis * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Bronchopneumonia * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Cellulitis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Folliculitis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Groin abscess * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Hepatitis A * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Pyelonephritis * 1  2/65 (3.08%)  0/65 (0.00%)  0/63 (0.00%) 
Syphilis * 1  1/65 (1.54%)  0/65 (0.00%)  1/63 (1.59%) 
Injury, poisoning and procedural complications       
Head injury * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Injury * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Meniscus lesion * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Multiple fractures * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc disorder * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Tendonitis * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Diffuse large B-cell lymphoma * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Nervous system disorders       
Sciatica * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Psychiatric disorders       
Depression * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Mental disorder * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Psychotic disorder * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Suicide attempt * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Renal impairment * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Renal papillary necrosis * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Leukocyturia * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lersivirine 500 mg Lersivirine 750 mg Efavirenz 600 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/65 (78.46%)   58/65 (89.23%)   59/63 (93.65%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Lymphadenopathy * 1  2/65 (3.08%)  2/65 (3.08%)  2/63 (3.17%) 
Neutropenia * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Cardiac disorders       
Atrioventricular block first degree * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Bradycardia * 1  1/65 (1.54%)  0/65 (0.00%)  1/63 (1.59%) 
Tachycardia * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Ventricular extrasystoles * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Congenital, familial and genetic disorders       
Hydrocele * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Ear and labyrinth disorders       
Ear pain * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Hypoacusis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Vertigo * 1  4/65 (6.15%)  1/65 (1.54%)  5/63 (7.94%) 
Eye disorders       
Chalazion * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Conjunctivitis * 1  3/65 (4.62%)  5/65 (7.69%)  2/63 (3.17%) 
Conjunctivitis allergic * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Dry eye * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Pterygium * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Pupils unequal * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Visual acuity reduced * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  1/65 (1.54%)  3/65 (4.62%)  0/63 (0.00%) 
Abdominal distension * 1  2/65 (3.08%)  4/65 (6.15%)  3/63 (4.76%) 
Abdominal pain * 1  2/65 (3.08%)  8/65 (12.31%)  8/63 (12.70%) 
Abdominal pain lower * 1  0/65 (0.00%)  2/65 (3.08%)  0/63 (0.00%) 
Abdominal pain upper * 1  3/65 (4.62%)  3/65 (4.62%)  1/63 (1.59%) 
Abdominal rigidity * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Abdominal tenderness * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Anal fissure * 1  1/65 (1.54%)  1/65 (1.54%)  0/63 (0.00%) 
Anal haemorrhage * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Anal ulcer * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Anogenital dysplasia * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Aphthous stomatitis * 1  0/65 (0.00%)  2/65 (3.08%)  1/63 (1.59%) 
Breath odour * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Cheilitis * 1  2/65 (3.08%)  1/65 (1.54%)  1/63 (1.59%) 
Colitis * 1  0/65 (0.00%)  2/65 (3.08%)  1/63 (1.59%) 
Constipation * 1  2/65 (3.08%)  0/65 (0.00%)  2/63 (3.17%) 
Dental caries * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Diarrhoea * 1  12/65 (18.46%)  12/65 (18.46%)  14/63 (22.22%) 
Dry mouth * 1  1/65 (1.54%)  0/65 (0.00%)  1/63 (1.59%) 
Dyspepsia * 1  1/65 (1.54%)  2/65 (3.08%)  2/63 (3.17%) 
Dysphagia * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Enteritis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Eructation * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Flatulence * 1  1/65 (1.54%)  1/65 (1.54%)  2/63 (3.17%) 
Food poisoning * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Frequent bowel movements * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Gastritis * 1  1/65 (1.54%)  2/65 (3.08%)  1/63 (1.59%) 
Gastrointestinal pain * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Gastrointestinal toxicity * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Gastrooesophageal reflux disease * 1  2/65 (3.08%)  3/65 (4.62%)  1/63 (1.59%) 
Gingival bleeding * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Gingival pain * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Gingivitis * 1  2/65 (3.08%)  0/65 (0.00%)  0/63 (0.00%) 
Haemorrhoids * 1  0/65 (0.00%)  3/65 (4.62%)  2/63 (3.17%) 
Inflammatory bowel disease * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Lip disorder * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Lip dry * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Mouth ulceration * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Nausea * 1  16/65 (24.62%)  28/65 (43.08%)  8/63 (12.70%) 
Oral disorder * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Palatal disorder * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Palatal oedema * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Periodontal disease * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Poor dental condition * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Proctalgia * 1  0/65 (0.00%)  0/65 (0.00%)  3/63 (4.76%) 
Rectal haemorrhage * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Rectal polyp * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Salivary gland enlargement * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Tongue coated * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Tongue ulceration * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Toothache * 1  2/65 (3.08%)  2/65 (3.08%)  1/63 (1.59%) 
Vomiting * 1  3/65 (4.62%)  12/65 (18.46%)  11/63 (17.46%) 
General disorders       
Asthenia * 1  2/65 (3.08%)  2/65 (3.08%)  4/63 (6.35%) 
Chest pain * 1  0/65 (0.00%)  3/65 (4.62%)  3/63 (4.76%) 
Cyst * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Drug withdrawal syndrome * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Fatigue * 1  2/65 (3.08%)  4/65 (6.15%)  3/63 (4.76%) 
Feeling abnormal * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Feeling drunk * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Influenza like illness * 1  3/65 (4.62%)  5/65 (7.69%)  2/63 (3.17%) 
Irritability * 1  2/65 (3.08%)  1/65 (1.54%)  1/63 (1.59%) 
Malaise * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Oedema peripheral * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Pain * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Pelvic mass * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Pyrexia * 1  1/65 (1.54%)  1/65 (1.54%)  0/63 (0.00%) 
Hepatobiliary disorders       
Hepatic lesion * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Immune system disorders       
House dust allergy * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Immune reconstitution syndrome * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Seasonal allergy * 1  1/65 (1.54%)  2/65 (3.08%)  0/63 (0.00%) 
Infections and infestations       
Abdominal abscess * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Abscess oral * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Acarodermatitis * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Acute sinusitis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Balanitis candida * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Body tinea * 1  0/65 (0.00%)  2/65 (3.08%)  1/63 (1.59%) 
Borrelia infection * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Bronchitis * 1  4/65 (6.15%)  9/65 (13.85%)  5/63 (7.94%) 
Bronchopneumonia * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Chlamydial infection * 1  2/65 (3.08%)  1/65 (1.54%)  1/63 (1.59%) 
Conjunctivitis viral * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Dysentery * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Eyelid infection * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Folliculitis * 1  2/65 (3.08%)  2/65 (3.08%)  2/63 (3.17%) 
Fungal skin infection * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Furuncle * 1  1/65 (1.54%)  1/65 (1.54%)  1/63 (1.59%) 
Gastroenteritis * 1  5/65 (7.69%)  5/65 (7.69%)  5/63 (7.94%) 
Gastroenteritis bacterial * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Genital herpes * 1  1/65 (1.54%)  0/65 (0.00%)  2/63 (3.17%) 
Gonorrhoea * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
H1N1 influenza * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Helicobacter infection * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Hepatitis A * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Hepatitis C * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Herpes dermatitis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Herpes zoster * 1  1/65 (1.54%)  4/65 (6.15%)  0/63 (0.00%) 
Herpes zoster ophthalmic * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Impetigo * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Infected bites * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Influenza * 1  5/65 (7.69%)  7/65 (10.77%)  8/63 (12.70%) 
Kaposi's varicelliform eruption * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Lower respiratory tract infection * 1  2/65 (3.08%)  3/65 (4.62%)  3/63 (4.76%) 
Molluscum contagiosum * 1  2/65 (3.08%)  0/65 (0.00%)  1/63 (1.59%) 
Nasopharyngitis * 1  8/65 (12.31%)  3/65 (4.62%)  4/63 (6.35%) 
Onychomycosis * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Oral candidiasis * 1  1/65 (1.54%)  2/65 (3.08%)  2/63 (3.17%) 
Oral hairy leukoplakia * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Oral herpes * 1  1/65 (1.54%)  2/65 (3.08%)  2/63 (3.17%) 
Orchitis * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Otitis externa * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Otitis media * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Otitis media acute * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Parasitic gastroenteritis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Paronychia * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Pelvic inflammatory disease * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Penile abscess * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Pharyngitis * 1  2/65 (3.08%)  2/65 (3.08%)  8/63 (12.70%) 
Respiratory tract infection * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Respiratory tract infection viral * 1  0/65 (0.00%)  2/65 (3.08%)  1/63 (1.59%) 
Rhinitis * 1  3/65 (4.62%)  1/65 (1.54%)  2/63 (3.17%) 
Sinusitis * 1  4/65 (6.15%)  2/65 (3.08%)  1/63 (1.59%) 
Skin candida * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Skin infection * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Subcutaneous abscess * 1  1/65 (1.54%)  1/65 (1.54%)  0/63 (0.00%) 
Syphilis * 1  6/65 (9.23%)  1/65 (1.54%)  3/63 (4.76%) 
Tinea cruris * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Tinea infection * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Tinea pedis * 1  4/65 (6.15%)  1/65 (1.54%)  0/63 (0.00%) 
Tonsillitis * 1  1/65 (1.54%)  2/65 (3.08%)  1/63 (1.59%) 
Tooth infection * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Tracheitis * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Upper respiratory tract infection * 1  10/65 (15.38%)  13/65 (20.00%)  14/63 (22.22%) 
Urethritis * 1  0/65 (0.00%)  1/65 (1.54%)  2/63 (3.17%) 
Urethritis chlamydial * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Urethritis gonococcal * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Urinary tract infection * 1  1/65 (1.54%)  2/65 (3.08%)  3/63 (4.76%) 
Vaginal infection * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Viral pharyngitis * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Viral upper respiratory tract infection * 1  1/65 (1.54%)  2/65 (3.08%)  1/63 (1.59%) 
Vulvovaginal candidiasis * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Vulvovaginal mycotic infection * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Injury, poisoning and procedural complications       
Alcohol poisoning * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Ankle fracture * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Arthropod bite * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Contusion * 1  1/65 (1.54%)  0/65 (0.00%)  1/63 (1.59%) 
Epicondylitis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Excoriation * 1  1/65 (1.54%)  1/65 (1.54%)  1/63 (1.59%) 
Face injury * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Fall * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Foot fracture * 1  1/65 (1.54%)  0/65 (0.00%)  1/63 (1.59%) 
Forearm fracture * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Fractured coccyx * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Head injury * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Joint dislocation * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Joint injury * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Laceration * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Ligament sprain * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Limb injury * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Muscle strain * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Post procedural haemorrhage * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Procedural pain * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Scratch * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Skeletal injury * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Stab wound * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Thermal burn * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Wound * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Investigations       
Alanine aminotransferase increased * 1  1/65 (1.54%)  1/65 (1.54%)  4/63 (6.35%) 
Aspartate aminotransferase increased * 1  1/65 (1.54%)  1/65 (1.54%)  4/63 (6.35%) 
Blood amylase increased * 1  1/65 (1.54%)  0/65 (0.00%)  1/63 (1.59%) 
Blood bilirubin increased * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Blood cholesterol increased * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Blood creatine phosphokinase increased * 1  2/65 (3.08%)  1/65 (1.54%)  4/63 (6.35%) 
Blood creatinine increased * 1  2/65 (3.08%)  0/65 (0.00%)  0/63 (0.00%) 
Blood glucose increased * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Blood lactate dehydrogenase increased * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Blood pressure increased * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Blood uric acid increased * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Blood urine present * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Body temperature increased * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Electrocardiogram QT prolonged * 1  2/65 (3.08%)  0/65 (0.00%)  0/63 (0.00%) 
Gamma-glutamyltransferase increased * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Lipase increased * 1  2/65 (3.08%)  0/65 (0.00%)  0/63 (0.00%) 
Liver function test abnormal * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Low density lipoprotein increased * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Protein urine present * 1  1/65 (1.54%)  0/65 (0.00%)  1/63 (1.59%) 
Serum ferritin decreased * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Vestibular function test * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Vitamin D decreased * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Weight decreased * 1  2/65 (3.08%)  1/65 (1.54%)  5/63 (7.94%) 
Weight increased * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
White blood cell count decreased * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
White blood cells urine * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  2/65 (3.08%)  0/65 (0.00%)  3/63 (4.76%) 
Hypoglycaemia * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Vitamin D deficiency * 1  1/65 (1.54%)  1/65 (1.54%)  0/63 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  5/65 (7.69%)  3/65 (4.62%)  3/63 (4.76%) 
Arthritis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Arthropathy * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Back pain * 1  5/65 (7.69%)  4/65 (6.15%)  6/63 (9.52%) 
Bursitis * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Chondrocalcinosis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Costochondritis * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Groin pain * 1  2/65 (3.08%)  1/65 (1.54%)  0/63 (0.00%) 
Hand deformity * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Inguinal mass * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Joint range of motion decreased * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Joint swelling * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Muscle spasms * 1  2/65 (3.08%)  0/65 (0.00%)  0/63 (0.00%) 
Musculoskeletal chest pain * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Musculoskeletal pain * 1  2/65 (3.08%)  2/65 (3.08%)  2/63 (3.17%) 
Myalgia * 1  1/65 (1.54%)  4/65 (6.15%)  2/63 (3.17%) 
Neck pain * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Pain in extremity * 1  3/65 (4.62%)  0/65 (0.00%)  2/63 (3.17%) 
Periarthritis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Tendonitis * 1  2/65 (3.08%)  0/65 (0.00%)  1/63 (1.59%) 
Tenosynovitis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Tenosynovitis stenosans * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital warts * 1  0/65 (0.00%)  3/65 (4.62%)  1/63 (1.59%) 
Basal cell carcinoma * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Blepharal papilloma * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Neoplasm * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Oral papilloma * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Skin papilloma * 1  3/65 (4.62%)  5/65 (7.69%)  0/63 (0.00%) 
Testicular neoplasm * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Nervous system disorders       
Areflexia * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Carpal tunnel syndrome * 1  0/65 (0.00%)  2/65 (3.08%)  0/63 (0.00%) 
Cerebrovascular accident * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Disturbance in attention * 1  1/65 (1.54%)  2/65 (3.08%)  3/63 (4.76%) 
Dizziness * 1  5/65 (7.69%)  5/65 (7.69%)  15/63 (23.81%) 
Dysarthria * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Dysgeusia * 1  1/65 (1.54%)  3/65 (4.62%)  1/63 (1.59%) 
Headache * 1  19/65 (29.23%)  14/65 (21.54%)  11/63 (17.46%) 
Hyperaesthesia * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Lethargy * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Memory impairment * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Migraine * 1  1/65 (1.54%)  1/65 (1.54%)  0/63 (0.00%) 
Nervous system disorder * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Neuropathy peripheral * 1  1/65 (1.54%)  0/65 (0.00%)  1/63 (1.59%) 
Nystagmus * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Paraesthesia * 1  1/65 (1.54%)  1/65 (1.54%)  1/63 (1.59%) 
Post herpetic neuralgia * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Presyncope * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Sciatica * 1  1/65 (1.54%)  1/65 (1.54%)  1/63 (1.59%) 
Somnolence * 1  3/65 (4.62%)  1/65 (1.54%)  1/63 (1.59%) 
Syncope * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Tension headache * 1  0/65 (0.00%)  2/65 (3.08%)  1/63 (1.59%) 
Psychiatric disorders       
Abnormal dreams * 1  5/65 (7.69%)  5/65 (7.69%)  12/63 (19.05%) 
Agitation * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Anxiety * 1  0/65 (0.00%)  5/65 (7.69%)  5/63 (7.94%) 
Attention deficit/hyperactivity disorder * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Depressed mood * 1  1/65 (1.54%)  2/65 (3.08%)  1/63 (1.59%) 
Depression * 1  3/65 (4.62%)  2/65 (3.08%)  3/63 (4.76%) 
Disturbance in sexual arousal * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Dysphoria * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Grief reaction * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Hallucination * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Initial insomnia * 1  1/65 (1.54%)  0/65 (0.00%)  1/63 (1.59%) 
Insomnia * 1  7/65 (10.77%)  9/65 (13.85%)  8/63 (12.70%) 
Libido decreased * 1  3/65 (4.62%)  0/65 (0.00%)  0/63 (0.00%) 
Libido increased * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Major depression * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Mental disorder * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Negative thoughts * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Nightmare * 1  3/65 (4.62%)  1/65 (1.54%)  3/63 (4.76%) 
Sleep disorder * 1  1/65 (1.54%)  1/65 (1.54%)  1/63 (1.59%) 
Suicidal ideation * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Renal and urinary disorders       
Dysuria * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Haematuria * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Leukocyturia * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Nocturia * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Polyuria * 1  2/65 (3.08%)  0/65 (0.00%)  1/63 (1.59%) 
Proteinuria * 1  4/65 (6.15%)  2/65 (3.08%)  1/63 (1.59%) 
Urinary incontinence * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Urine odour abnormal * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Reproductive system and breast disorders       
Balanitis * 1  2/65 (3.08%)  0/65 (0.00%)  0/63 (0.00%) 
Cervical dysplasia * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Dysmenorrhoea * 1  1/65 (1.54%)  1/65 (1.54%)  0/63 (0.00%) 
Epididymitis * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Erectile dysfunction * 1  5/65 (7.69%)  1/65 (1.54%)  2/63 (3.17%) 
Genital rash * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Menopausal symptoms * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Menorrhagia * 1  0/65 (0.00%)  2/65 (3.08%)  0/63 (0.00%) 
Metrorrhagia * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Perineal ulceration * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Prostatism * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Prostatitis * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Testicular pain * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Vaginal discharge * 1  0/65 (0.00%)  2/65 (3.08%)  0/63 (0.00%) 
Vaginal disorder * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Vaginal haemorrhage * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Vulvovaginal pruritus * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Bronchiectasis * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Bronchospasm * 1  0/65 (0.00%)  2/65 (3.08%)  0/63 (0.00%) 
Cough * 1  5/65 (7.69%)  4/65 (6.15%)  3/63 (4.76%) 
Dysphonia * 1  1/65 (1.54%)  1/65 (1.54%)  1/63 (1.59%) 
Dyspnoea * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Epistaxis * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Hyperventilation * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Nasal congestion * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Nasal inflammation * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Oropharyngeal pain * 1  1/65 (1.54%)  2/65 (3.08%)  4/63 (6.35%) 
Pharyngeal disorder * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Pleuritic pain * 1  2/65 (3.08%)  0/65 (0.00%)  0/63 (0.00%) 
Productive cough * 1  0/65 (0.00%)  2/65 (3.08%)  0/63 (0.00%) 
Pulmonary oedema * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Rhinitis allergic * 1  1/65 (1.54%)  2/65 (3.08%)  1/63 (1.59%) 
Rhinorrhoea * 1  2/65 (3.08%)  1/65 (1.54%)  0/63 (0.00%) 
Sleep apnoea syndrome * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Upper-airway cough syndrome * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Skin and subcutaneous tissue disorders       
Acne * 1  4/65 (6.15%)  2/65 (3.08%)  0/63 (0.00%) 
Actinic keratosis * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Alopecia * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Dermatitis * 1  2/65 (3.08%)  2/65 (3.08%)  2/63 (3.17%) 
Dermatitis allergic * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Dermatitis contact * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Dermatosis * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Drug eruption * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Dry skin * 1  3/65 (4.62%)  0/65 (0.00%)  1/63 (1.59%) 
Eczema * 1  0/65 (0.00%)  2/65 (3.08%)  1/63 (1.59%) 
Erythema * 1  2/65 (3.08%)  0/65 (0.00%)  0/63 (0.00%) 
Facial wasting * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Heat rash * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Night sweats * 1  1/65 (1.54%)  0/65 (0.00%)  4/63 (6.35%) 
Papule * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Pityriasis * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Pruritus * 1  0/65 (0.00%)  1/65 (1.54%)  3/63 (4.76%) 
Rash * 1  2/65 (3.08%)  1/65 (1.54%)  5/63 (7.94%) 
Rash erythematous * 1  0/65 (0.00%)  0/65 (0.00%)  2/63 (3.17%) 
Rash macular * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Rash maculo-papular * 1  1/65 (1.54%)  0/65 (0.00%)  1/63 (1.59%) 
Rash pruritic * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Rosacea * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Seborrhoea * 1  0/65 (0.00%)  1/65 (1.54%)  1/63 (1.59%) 
Skin exfoliation * 1  0/65 (0.00%)  2/65 (3.08%)  0/63 (0.00%) 
Skin lesion * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Surgical and medical procedures       
Lymphadenectomy * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Vascular disorders       
Deep vein thrombosis * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Hyperaemia * 1  0/65 (0.00%)  1/65 (1.54%)  0/63 (0.00%) 
Hypertension * 1  1/65 (1.54%)  0/65 (0.00%)  2/63 (3.17%) 
Hypotension * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
Labile hypertension * 1  1/65 (1.54%)  0/65 (0.00%)  0/63 (0.00%) 
Thrombophlebitis * 1  0/65 (0.00%)  0/65 (0.00%)  1/63 (1.59%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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.
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: NCT00824421     History of Changes
Other Study ID Numbers: A5271015
First Submitted: January 15, 2009
First Posted: January 16, 2009
Results First Submitted: December 9, 2013
Results First Posted: January 24, 2014
Last Update Posted: January 24, 2014