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A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022

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ClinicalTrials.gov Identifier: NCT01254656
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : December 6, 2010
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1
Interventions Drug: lersivirine
Drug: efavirenz
Drug: etravirine
Enrollment 108
Recruitment Details Participants who had completed 96 weeks of treatment with lersivirine in the A5271015 parent study were enrolled in this extension study. One participant from a second parent study (A5271022) was initially enrolled in Study A5271037, but later discontinued from A5271037.
Pre-assignment Details Participants were required to have plasma HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 84 of the parent protocol. Of 108 participants screened in the parent protocol A5271015, 47, 43, and 18 participants from the lersivirine 500 mg, lersivirine 750 mg, and efavirenz 600 mg groups, respectively, were enrolled in Study A5271037.
Arm/Group Title Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg
Hide Arm/Group Description Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Period Title: Overall Study
Started 47 43 18
Treated 47 43 18
Completed 0 0 0
Not Completed 47 43 18
Reason Not Completed
Discontinued due to termination of study             40             39             13
Lack of Efficacy             3             0             0
Lost to Follow-up             1             0             2
Withdrawal by Subject             2             2             1
Pregnancy             0             0             2
Adverse Event             1             1             0
Death             0             1             0
Arm/Group Title Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg Total
Hide Arm/Group Description Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD Total of all reporting groups
Overall Number of Baseline Participants 47 43 18 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 43 participants 18 participants 108 participants
36.6  (8.4) 35.8  (8.7) 38.5  (7.8) 36.6  (8.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 47 participants 43 participants 18 participants 108 participants
< 18 Years 0 0 0 0
18 - 44 Years 41 37 14 92
45 - 64 Years 6 6 4 16
>= 65 Years 0 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 43 participants 18 participants 108 participants
Female
10
  21.3%
11
  25.6%
8
  44.4%
29
  26.9%
Male
37
  78.7%
32
  74.4%
10
  55.6%
79
  73.1%
1.Primary Outcome
Title Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV-1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol
Hide Description Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at 48 weeks i.e. 144 weeks from Day 1 of the parent protocol. Roche Amplicor HIV-1 Monitor assay was used to measure the HIV-1 RNA level.
Time Frame 144 Weeks from Day 1 of the parent protocol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses.
Arm/Group Title Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg
Hide Arm/Group Description:
Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Overall Number of Participants Analyzed 47 43 18
Measure Type: Number
Unit of Measure: Participants
40 40 16
2.Secondary Outcome
Title Number of Participants With Plasma HIV-1 RNA Level <50 Copies/mL up to Week 208
Hide Description Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at last visit. Abbott RealTime HIV-1 assay was used to measure the HIV-1 RNA level.
Time Frame Up to Week 208
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses included all enrolled participants. Last visit used the last available visit of each participant. Discontinued from study, lost to follow-up, or missing HIV-1 RNA level data at last visit were considered to have HIV-1 RNA levels >=50 copies/mL. Participants discontinued due to program termination were not considered as discontinuations.
Arm/Group Title Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg
Hide Arm/Group Description:
Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Overall Number of Participants Analyzed 47 43 18
Measure Type: Number
Unit of Measure: Participants
39 38 13
3.Secondary Outcome
Title Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol
Hide Description Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)
Time Frame 144 Weeks from Day 1 of the parent protocol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. Last observation carried forward (LOCF) was used to impute missing values.
Arm/Group Title Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg
Hide Arm/Group Description:
Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Overall Number of Participants Analyzed 47 43 18
Mean (Standard Deviation)
Unit of Measure: cells/uL
293  (206) 302  (163) 303  (163)
4.Secondary Outcome
Title Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol
Hide Description Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)
Time Frame 144 Weeks from Day 1 of the parent protocol
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. LOCF was used to impute missing values.
Arm/Group Title Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg
Hide Arm/Group Description:
Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Overall Number of Participants Analyzed 47 43 18
Mean (Standard Deviation)
Unit of Measure: Percentage
13  (6) 13  (5) 13  (6)
5.Secondary Outcome
Title Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol
Hide Description Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.
Time Frame 192 Weeks from Day 1 of the parent protocol
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses included all enrolled participants. Week 192 data are presented, as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.
Arm/Group Title Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg
Hide Arm/Group Description:
Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Overall Number of Participants Analyzed 38 34 18
Mean (Standard Deviation)
Unit of Measure: cells/uL
308  (191) 304  (159) 300  (220)
6.Secondary Outcome
Title Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol
Hide Description Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.
Time Frame 192 Weeks from Day 1 of the parent protocol
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses included all enrolled participants. Week 192 data are presented as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.
Arm/Group Title Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg
Hide Arm/Group Description:
Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Overall Number of Participants Analyzed 38 34 18
Mean (Standard Deviation)
Unit of Measure: Percentage
13  (6) 15  (6) 12  (6)
7.Secondary Outcome
Title Virology Analysis Participant Accountability From Week 96 Through Study Termination
Hide Description Virology analysis included virus susceptibility (phenotype and genotype)to a standard panel of approved antiretrovirals as determined by the Monogram Biosciences PhenoSense GT assay. Below analysis table included the following parameters: 1. "protocol-defined treatment failure" was defined as an increase in HIV-1 RNA to detectable levels (≥50 copies/mL) on 2 consecutive measurements, the second measurement taken no more than 14 days after the first measurement); 2. "Treatment failure": treatment failure (both virologic and non-virologic) was defined as a subject who met the protocol-defined treatment failure criterion or discontinued from the study; 3. "NRTI or NNRTI resistance mutations": nucleoside reverse transcriptase inhibitor or lersivirine-associated resistance-associated mutations (RAM) based on the International AIDS Society-USA (IAS-USA) RAM guidelines; 4. 'with result' meant an analyzed sample returned genotypic result or phenotypic result or both.
Time Frame Week 96 through study termination
Hide Outcome Measure Data
Hide Analysis Population Description
The virology analysis set included only evaluable participants i.e. those having samples with valid genotypic or phenotypic susceptibility testing results and HIV-1 RNA >500 copies/mL. However, samples with observed emergence of resistance-associated mutations and HIV-1 RNA level ≤500 copies/mL or missing HIV-1 RNA level, were also noted.
Arm/Group Title Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg
Hide Arm/Group Description:
Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
Overall Number of Participants Analyzed 47 43 18
Measure Type: Number
Unit of Measure: Participants
Treatment failure (TF) 8 5 5
Protocol defined treatment failure 4 3 0
TF analysed - HIV-1 RNA >500 c/mL 1 0 0
TF analysed - HIV-1 RNA >500 c/mL with result 1 0 0
TF analysed - HIV-1 RNA <= 500 c/mL 5 2 2
TF analysed - HIV-1 RNA <= 500 c/mL with result 2 1 0
NRTI or NNRTI resistance mutations 0 0 0
Time Frame Up to Week 208
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Treatment emergent AEs included new treatment emergent AEs in A5271037 as well as AEs that were ongoing at the time of enrolment in A5271037 and had a worsened severity grading from that reported in A5271015. All causality events were reported.
 
Arm/Group Title Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg
Hide Arm/Group Description Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
All-Cause Mortality
Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/47 (12.77%)   5/43 (11.63%)   0/18 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal haemorrhage * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Large intestine perforation * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Hepatobiliary disorders       
Biliary colic * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Cholelithiasis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Hepatitis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Infections and infestations       
Chronic sinusitis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Gastroenteritis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Hepatitis C * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Syphilis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Injury, poisoning and procedural complications       
Chest injury * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Road traffic accident * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Wound * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Investigations       
Blood creatine phosphokinase increased * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Blood lactate dehydrogenase increased * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cervix carcinoma * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Gastrointestinal carcinoma * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Ovarian adenoma * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Vaginal cancer * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Psychiatric disorders       
Paranoia * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lersivirine (LRV) 500 mg LRV 750 mg Efavirenz (EFV) 600 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   30/47 (63.83%)   35/43 (81.40%)   15/18 (83.33%) 
Blood and lymphatic system disorders       
Eosinophilia * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Lymphadenitis * 1  0/47 (0.00%)  0/43 (0.00%)  1/18 (5.56%) 
Lymphadenopathy * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Cardiac disorders       
Bradycardia * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Myocardial ischaemia * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Ear and labyrinth disorders       
Cerumen impaction * 1  1/47 (2.13%)  1/43 (2.33%)  0/18 (0.00%) 
Tinnitus * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Eye disorders       
Chalazion * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Conjunctivitis * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Conjunctivitis allergic * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Ocular toxicity * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  0/47 (0.00%)  2/43 (4.65%)  0/18 (0.00%) 
Abdominal pain lower * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Abdominal tenderness * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Anal fissure * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Anogenital dysplasia * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Aphthous stomatitis * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Colitis * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Constipation * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Diarrhoea * 1  0/47 (0.00%)  3/43 (6.98%)  0/18 (0.00%) 
Diverticulum * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Dyspepsia * 1  1/47 (2.13%)  3/43 (6.98%)  0/18 (0.00%) 
Dysphagia * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Gastritis * 1  0/47 (0.00%)  2/43 (4.65%)  1/18 (5.56%) 
Nausea * 1  0/47 (0.00%)  2/43 (4.65%)  0/18 (0.00%) 
Palatal disorder * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Proctalgia * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Proctitis ulcerative * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Rectal haemorrhage * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Toothache * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Vomiting * 1  1/47 (2.13%)  0/43 (0.00%)  1/18 (5.56%) 
General disorders       
Asthenia * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Chest pain * 1  1/47 (2.13%)  3/43 (6.98%)  0/18 (0.00%) 
Discomfort * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Fatigue * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Influenza like illness * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Mucosal inflammation * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Nodule * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Oedema peripheral * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Pyrexia * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Hepatobiliary disorders       
Biliary colic * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Hepatic cyst * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Hepatic steatosis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Immune system disorders       
Seasonal allergy * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Infections and infestations       
Anal chlamydia infection * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Bronchitis * 1  0/47 (0.00%)  2/43 (4.65%)  0/18 (0.00%) 
Chlamydial infection * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Chronic sinusitis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Ear infection * 1  0/47 (0.00%)  2/43 (4.65%)  0/18 (0.00%) 
Eyelid infection * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Furuncle * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Gastroenteritis * 1  0/47 (0.00%)  2/43 (4.65%)  1/18 (5.56%) 
Gastrointestinal infection * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Gonorrhoea * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Hepatitis C * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Herpes simplex * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Influenza * 1  0/47 (0.00%)  2/43 (4.65%)  1/18 (5.56%) 
Labyrinthitis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Lower respiratory tract infection * 1  0/47 (0.00%)  0/43 (0.00%)  1/18 (5.56%) 
Nasopharyngitis * 1  1/47 (2.13%)  2/43 (4.65%)  0/18 (0.00%) 
Onychomycosis * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Oral herpes * 1  2/47 (4.26%)  1/43 (2.33%)  1/18 (5.56%) 
Oropharyngeal gonococcal infection * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Paronychia * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Pharyngitis * 1  0/47 (0.00%)  4/43 (9.30%)  2/18 (11.11%) 
Pneumonia * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Proctitis gonococcal * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Pyelonephritis * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Respiratory tract infection * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Rhinitis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Subcutaneous abscess * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Syphilis * 1  1/47 (2.13%)  0/43 (0.00%)  1/18 (5.56%) 
Tinea barbae * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Tinea cruris * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Tinea infection * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Tinea pedis * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Tonsillitis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Tooth infection * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Upper respiratory tract infection * 1  1/47 (2.13%)  2/43 (4.65%)  3/18 (16.67%) 
Urethritis * 1  1/47 (2.13%)  1/43 (2.33%)  0/18 (0.00%) 
Urinary tract infection * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Vaginal infection * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Vulvovaginal candidiasis * 1  0/47 (0.00%)  0/43 (0.00%)  1/18 (5.56%) 
Injury, poisoning and procedural complications       
Epicondylitis * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Exposure to communicable disease * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Fall * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Laceration * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Ligament sprain * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Muscle rupture * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Radius fracture * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Tooth fracture * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Wound * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Investigations       
Aspartate aminotransferase increased * 1  0/47 (0.00%)  2/43 (4.65%)  0/18 (0.00%) 
Blood cholesterol increased * 1  2/47 (4.26%)  0/43 (0.00%)  0/18 (0.00%) 
Blood creatine phosphokinase increased * 1  1/47 (2.13%)  2/43 (4.65%)  0/18 (0.00%) 
Blood creatinine increased * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Blood glucose increased * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Blood lactate dehydrogenase abnormal * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Blood triglycerides increased * 1  0/47 (0.00%)  0/43 (0.00%)  1/18 (5.56%) 
Blood uric acid increased * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Cardiac murmur * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Hepatic enzyme increased * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Lipids increased * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Low density lipoprotein increased * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Parasitic test positive * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Simplex virus test positive * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Weight decreased * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Weight increased * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Hyperlipidaemia * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Hyperuricaemia * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/47 (2.13%)  4/43 (9.30%)  0/18 (0.00%) 
Back pain * 1  4/47 (8.51%)  3/43 (6.98%)  2/18 (11.11%) 
Bursitis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Joint swelling * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Muscle spasms * 1  0/47 (0.00%)  1/43 (2.33%)  2/18 (11.11%) 
Musculoskeletal pain * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Myalgia * 1  0/47 (0.00%)  1/43 (2.33%)  1/18 (5.56%) 
Neck pain * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Osteoarthritis * 1  0/47 (0.00%)  0/43 (0.00%)  1/18 (5.56%) 
Osteopenia * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Osteoporosis * 1  0/47 (0.00%)  2/43 (4.65%)  0/18 (0.00%) 
Seronegative arthritis * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Synovial cyst * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital warts * 1  1/47 (2.13%)  1/43 (2.33%)  0/18 (0.00%) 
Basal cell carcinoma * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Skin papilloma * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Nervous system disorders       
Areflexia * 1  0/47 (0.00%)  2/43 (4.65%)  2/18 (11.11%) 
Dizziness * 1  1/47 (2.13%)  0/43 (0.00%)  1/18 (5.56%) 
Dizziness postural * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Headache * 1  2/47 (4.26%)  1/43 (2.33%)  1/18 (5.56%) 
Hyperaesthesia * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Hyporeflexia * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Loss of consciousness * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Migraine * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Syncope * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Pregnancy * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Psychiatric disorders       
Anxiety * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Depression * 1  1/47 (2.13%)  3/43 (6.98%)  0/18 (0.00%) 
Insomnia * 1  1/47 (2.13%)  1/43 (2.33%)  0/18 (0.00%) 
Major depression * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Renal and urinary disorders       
Haematuria * 1  2/47 (4.26%)  1/43 (2.33%)  0/18 (0.00%) 
Proteinuria * 1  1/47 (2.13%)  1/43 (2.33%)  0/18 (0.00%) 
Renal cyst * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Renal failure * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Renal impairment * 1  0/47 (0.00%)  0/43 (0.00%)  1/18 (5.56%) 
Urethral haemorrhage * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Reproductive system and breast disorders       
Epididymal cyst * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Epididymitis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Genital lesion * 1  0/47 (0.00%)  0/43 (0.00%)  1/18 (5.56%) 
Gynaecomastia * 1  0/47 (0.00%)  0/43 (0.00%)  1/18 (5.56%) 
Ovarian cyst * 1  0/47 (0.00%)  0/43 (0.00%)  1/18 (5.56%) 
Perineal erythema * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Perineal pain * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Testicular microlithiasis * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchitis chronic * 1  0/47 (0.00%)  0/43 (0.00%)  1/18 (5.56%) 
Cough * 1  0/47 (0.00%)  2/43 (4.65%)  2/18 (11.11%) 
Oropharyngeal pain * 1  1/47 (2.13%)  2/43 (4.65%)  0/18 (0.00%) 
Pharyngeal disorder * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Productive cough * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Rhinitis allergic * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Upper-airway cough syndrome * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders       
Blister * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Dermatitis * 1  1/47 (2.13%)  1/43 (2.33%)  0/18 (0.00%) 
Dry skin * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Eczema * 1  0/47 (0.00%)  2/43 (4.65%)  1/18 (5.56%) 
Lentigo * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Lipoatrophy * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Pruritus * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Rash * 1  3/47 (6.38%)  1/43 (2.33%)  1/18 (5.56%) 
Seborrhoea * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Seborrhoeic dermatitis * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Skin disorder * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Skin exfoliation * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Urticaria * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Vascular disorders       
Hot flush * 1  0/47 (0.00%)  0/43 (0.00%)  1/18 (5.56%) 
Hypertension * 1  1/47 (2.13%)  0/43 (0.00%)  0/18 (0.00%) 
Spider vein * 1  0/47 (0.00%)  1/43 (2.33%)  0/18 (0.00%) 
Varicose vein * 1  0/47 (0.00%)  0/43 (0.00%)  1/18 (5.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
The study was terminated on 29 Jan 13 due to termination of lersivirine development program. All participants were enrolled from study A5271015 except one from A5271022. Above summarized outcome measures included participants enrolled from A5271015.
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01254656    
Other Study ID Numbers: A5271037
First Submitted: December 3, 2010
First Posted: December 6, 2010
Results First Submitted: January 21, 2014
Results First Posted: June 9, 2014
Last Update Posted: June 9, 2014