A Rollover Study For Subjects Discontinuing From UK-453,0... | NCT00824369 | Trialant
NCT00824369
Sponsor
Pfizer
Status
Terminated
Last Update Posted
Aug 4, 2014Estimated
Enrollment
52Actual
Phase
Phase 2
Conditions
HIV-1
Interventions
No drug will be administered
Countries
United States
Argentina
Brazil
Italy
Malaysia
Poland
Portugal
Puerto Rico
South Africa
Switzerland
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00824369
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A5271038
Secondary IDs
Not provided
Brief Title
A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1
Official Title
A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jul 2014
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
See termination reason in detailed description.
Expanded Access Info
No
Start Date
Jul 2009
Primary Completion Date
Jul 2013Actual
Completion Date
Jul 2013Actual
First Submitted Date
Jan 15, 2009
First Submission Date that Met QC Criteria
Jan 15, 2009
First Posted Date
Jan 16, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 16, 2014
Results First Submitted that Met QC Criteria
Jul 31, 2014
Results First Posted Date
Aug 4, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 31, 2014
Last Update Posted Date
Aug 4, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Name
Class
ViiV Healthcare
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.
Detailed Description
To assess long term safety and tolerability of subjects who discontinue for any reason from UK-453,061 studies. The study will also assess efficacy of the subsequent regimens in these patients. The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.
Conditions Module
Conditions
HIV-1
Keywords
HIV-1
Rollover
Safety.
HIV Infections
treatment experienced
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
52Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Anti-retroviral therapy
No Intervention
Anti-retroviral therapy
Drug: No drug will be administered
Interventions
Name
Type
Description
Arm Group Labels
Other Names
No drug will be administered
Drug
No drug will be administered.
Anti-retroviral therapy
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events
The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.
End of Study visit or the Early Termination visit
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit
Number of participants with HIV-1 RNA level <50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.
Baseline, Month 6, Month 12 and Last visit
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Previous participation in a qualifying study.
Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
Exclusion Criteria:
Concurrent treatment in another clinical trial.
Unwilling or unable to be followed for 12 months
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pfizer Investigational Site
Sacramento
California
95814
United States
Pfizer Investigational Site
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Twelve and 40 participants who had received: LRV 500 mg QD, LRV 750 mg QD or efavirenz 600 mg QD (in A5271015);or LRV 750 mg QD, LRV 1000 mg QD or etravirine 200 mg BID (in A5271022) were enrolled and treated with open-label antiretrovirals excluding LRV. Data summaries were provided by the randomized treatment groups of the parent protocol.
Recruitment Details
Participants from two parent studies (A5271015 and A5271022) were included if they discontinued treatment due to virologic failure or other reasons. Participants from 6 countries were enrolled into the A5271015 study and the A5271022 study enrolled participants from 8 countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Participants From A5271015 - Lersivirine 500 mg Arm
Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
FG001
Participants From A5271015 - Lersivirine 750 mg Arm
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Canada
France
Germany
Mexico
Spain
Taiwan
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Not provided
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit
Number of participants with HIV-1 RNA level <50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.
Baseline, Month 6, Month 12 and Last visit
Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12
Participant's immunological status assessed by CD4+ lymphocyte count.
Baseline, Month 6 and Month 12
CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12
Participant's immunological status assessed by CD4+ lymphocyte count.
Baseline, Month 6 and Month 12
Sacramento
California
95817
United States
Pfizer Investigational Site
Miami
Florida
33137
United States
Pfizer Investigational Site
Atlanta
Georgia
30308
United States
Pfizer Investigational Site
Cincinnati
Ohio
45267
United States
Pfizer Investigational Site
Dallas
Texas
75235
United States
Pfizer Investigational Site
Buenos Aires
C1405BCH
Argentina
Pfizer Investigational Site
Curitiba
Paraná
80240-280
Brazil
Pfizer Investigational Site
Nova Iguaçu
Rio de Janeiro
26030-381
Brazil
Pfizer Investigational Site
Campinas
São Paulo
13015-080
Brazil
Pfizer Investigational Site
São Paulo
São Paulo
04121-000
Brazil
Pfizer Investigational Site
Milan
20127
Italy
Pfizer Investigational Site
Kota Bharu
Kelantan
15586
Malaysia
Pfizer Investigational Site
Warsaw
01-201
Poland
Pfizer Investigational Site
Lisbon
1349-019
Portugal
Pfizer Investigational Site
Porto
4200-319
Portugal
Pfizer Investigational Site
Ponce
00717-1563
Puerto Rico
Pfizer Investigational Site
Santurce
00909
Puerto Rico
Pfizer Investigational Site
Dundee
KwaZulu-Natal
3000
South Africa
Pfizer Investigational Site
Cape Town
Western Cape
7925
South Africa
Pfizer Investigational Site
Lugano
6903
Switzerland
Pfizer Investigational Site
Sankt Gallen
9007
Switzerland
Pfizer Investigational Site
Donetsk
83045
Ukraine
Pfizer Investigational Site
Edinburgh
EH3 9HA
United Kingdom
Pfizer Investigational Site
Edinburgh
EH4 2XU
United Kingdom
Pfizer Investigational Site
London
SW10 9NH
United Kingdom
Pfizer Investigational Site
Manchester
M8 5RB
United Kingdom
Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
FG002
Participants From A5271015 - Efavirenz 600 mg Arm
Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
FG003
Participants From A5271022 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
FG004
Participants From A5271022 - Lersivirine 1000 mg Arm
Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
FG005
Participants From A5271022 - Etravirine 200 mg Arm
Participants who had received etravirine 200 mg twice daily in A5271022 parent study
FG0005 subjects
FG0014 subjects
FG0023 subjects
FG00311 subjects
FG00412 subjects
FG00517 subjects
COMPLETED
FG0004 subjects
FG0014 subjects
FG0022 subjects
FG0039 subjects
FG00411 subjects
FG00516 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0041 subjects
FG0051 subjects
Type
Comment
Reasons
Nolonger willing to participate in study
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Participants From A5271015 - Lersivirine 500 mg Arm
Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
BG001
Participants From A5271015 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
BG002
Participants From A5271015 - Efavirenz 600 mg Arm
Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
BG003
Participants From A5271022 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
BG004
Participants From A5271022 - Lersivirine 1000 mg Arm
Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
BG005
Participants From A5271022 - Etravirine 200 mg Arm
Participants who had received etravirine 200 mg twice daily in A5271022 parent study
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG0014
BG0023
BG00311
BG00412
BG00517
BG00652
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Mean
Standard Deviation
years
Title
Denominators
Categories
Participants from A5271015
Title
Measurements
BG00033.8± 6.1
BG00131.5± 1.7
BG00238.3± 3.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events
The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.
Safety population consisted of all participants who were enrolled in this study.
Posted
Number
Number of participants
End of Study visit or the Early Termination visit
ID
Title
Description
OG000
Participants From A5271015 - Lersivirine 500 mg Arm
Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
OG001
Participants From A5271015 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
OG002
Participants From A5271015 - Efavirenz 600 mg Arm
Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
OG003
Participants From A5271022 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
OG004
Participants From A5271022 - Lersivirine 1000 mg Arm
Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
OG005
Participants From A5271022 - Etravirine 200 mg Arm
Participants who had received etravirine 200 mg twice daily in A5271022 parent study
Units
Counts
Participants
OG0005
OG0014
OG0023
OG003
Title
Denominators
Categories
Number of participants with adverse events
Title
Measurements
OG0003
OG0014
OG0022
OG003
Secondary
Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit
Number of participants with HIV-1 RNA level <50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.
Analysis population consisted of all participants who were enrolled. The lower limit of quantification of the HIV 1 RNA assays ranged from 20-70 copies/mL as they were performed by local labs. Participants where the HIV-RNA level was with a LLOQ > 50 copies/mL were not included in the analysis at the visit of interest. Only available data was used.
Posted
Number
Number of participants
Baseline, Month 6, Month 12 and Last visit
ID
Title
Description
OG000
Participants From A5271015 - Lersivirine 500 mg Arm
Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
OG001
Participants From A5271015 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
OG002
Participants From A5271015 - Efavirenz 600 mg Arm
Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
Secondary
Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit
Number of participants with HIV-1 RNA level <50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.
Analysis population consisted of all participants who were enrolled in this study. Only available data were used.
Posted
Number
Number of participants
Baseline, Month 6, Month 12 and Last visit
ID
Title
Description
OG000
Participants From A5271015 - Lersivirine 500 mg Arm
Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
OG001
Participants From A5271015 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
OG002
Participants From A5271015 - Efavirenz 600 mg Arm
Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
Secondary
Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12
Participant's immunological status assessed by CD4+ lymphocyte count.
Analysis population consisted of all participants who were enrolled in this study. Only available data were used.
Posted
Mean
Standard Deviation
cells/uL
Baseline, Month 6 and Month 12
ID
Title
Description
OG000
Participants From A5271015 - Lersivirine 500 mg Arm
Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
OG001
Participants From A5271015 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
OG002
Participants From A5271015 - Efavirenz 600 mg Arm
Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
OG003
Participants From A5271022 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
Secondary
CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12
Participant's immunological status assessed by CD4+ lymphocyte count.
Analysis population consisted of all participants who were enrolled in this study. Only available data were used.
Posted
Mean
Standard Deviation
Percentage of total lymphocytes
Baseline, Month 6 and Month 12
ID
Title
Description
OG000
Participants From A5271015 - Lersivirine 500 mg Arm
Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
OG001
Participants From A5271015 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
OG002
Participants From A5271015 - Efavirenz 600 mg Arm
Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
OG003
Participants From A5271022 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
Time Frame
End of Study visit or the Early Termination visit
Description
There were no serious adverse events experienced by the subjects in this study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Participants From A5271015 - Lersivirine 500 mg Arm
Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
0
5
3
5
EG001
Participants From A5271015 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
0
4
4
4
EG002
Participants From A5271015 - Efavirenz 600 mg Arm
Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
0
3
2
3
EG003
Participants From A5271022 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
0
11
6
11
EG004
Participants From A5271022 - Lersivirine 1000 mg Arm
Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
0
12
7
12
EG005
Participants From A5271022 - Etravirine 200 mg Arm
Participants who had received etravirine 200 mg twice daily in A5271022 parent study
0
17
11
17
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain lower
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0013 affected4 at risk
EG0022 affected3 at risk
EG0030 affected11 at risk
EG0040 affected12 at risk
EG0050 affected17 at risk
Anal haemorrhage
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0012 affected4 at risk
EG0021 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Varicella
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 15.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Stress
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Epididymitis
Reproductive system and breast disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cyst
General disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Salpingo-oophoritis
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood glucose increased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood pressure increased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Lichen planus
Skin and subcutaneous tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 15.1
Non-systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D015658
HIV Infections
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D015229
Sexually Transmitted Diseases, Viral
D012749
Sexually Transmitted Diseases
D016180
Lentivirus Infections
D012192
Retroviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D007153
Immunologic Deficiency Syndromes
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
NA
± NA
This arm belongs to the study A5271022 and not A5271015.
BG004NA± NAThis arm belongs to the study A5271022 and not A5271015.
BG005NA± NAThis arm belongs to the study A5271022 and not A5271015.
BG00634.2± 4.8
Participants from A5271022
Title
Measurements
BG000NA± NAThis arm belongs to the study A5271015 and not A5271022.
BG001NA± NAThis arm belongs to the study A5271015 and not A5271022.
BG002NA± NAThis arm belongs to the study A5271015 and not A5271022.
BG00342.7± 9.1
BG00439.1± 9.0
BG00541.6± 9.4
BG00641.2± 9.1
1
BG0035
BG0047
BG00511
BG00628
Male
BG0003
BG0012
BG0022
BG0036
BG0045
BG0056
BG00624
11
OG00412
OG00517
6
OG0047
OG00511
Number of participants with serious adverse events
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants discontinued due to adverse events
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG003
Participants From A5271022 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
OG004
Participants From A5271022 - Lersivirine 1000 mg Arm
Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
OG005
Participants From A5271022 - Etravirine 200 mg Arm
Participants who had received etravirine 200 mg twice daily in A5271022 parent study
Units
Counts
Participants
OG0005
OG0014
OG0023
OG00311
OG00412
OG00517
Title
Denominators
Categories
Baseline (N = 5, 4, 3, 11, 12, 17)
Title
Measurements
OG0002
OG0013
OG0020
OG0039
OG0047
OG00515
Month 6 (N = 3, 2, 3, 8, 11, 15)
Title
Measurements
OG0002
OG0012
OG0022
OG003
Month 12 (N = 3, 3, 1, 2, 5, 7)
Title
Measurements
OG0002
OG0013
OG0020
OG003
Last Visit (N = 4, 3, 3, 11, 12, 17)
Title
Measurements
OG0003
OG0013
OG0021
OG003
OG003
Participants From A5271022 - Lersivirine 750 mg Arm
Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
OG004
Participants From A5271022 - Lersivirine 1000 mg Arm
Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
OG005
Participants From A5271022 - Etravirine 200 mg Arm
Participants who had received etravirine 200 mg twice daily in A5271022 parent study
Units
Counts
Participants
OG0005
OG0014
OG0023
OG00311
OG00412
OG00517
Title
Denominators
Categories
Baseline (N = 5, 4, 3, 11, 12, 17)
Title
Measurements
OG0002
OG0013
OG0020
OG0039
OG0047
OG00515
Month 6 (N = 4, 4, 3, 8, 11, 15)
Title
Measurements
OG0003
OG0014
OG0022
OG003
Month 12 (N = 4, 4, 1, 2, 5, 7)
Title
Measurements
OG0003
OG0014
OG0020
OG003
Last Visit (N = 5, 4, 3, 11, 12, 17)
Title
Measurements
OG0004
OG0014
OG0021
OG003
OG004
Participants From A5271022 - Lersivirine 1000 mg Arm
Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
OG005
Participants From A5271022 - Etravirine 200 mg Arm
Participants who had received etravirine 200 mg twice daily in A5271022 parent study
Units
Counts
Participants
OG0005
OG0014
OG0023
OG00311
OG00412
OG00517
Title
Denominators
Categories
Baseline (N = 4, 4, 3, 11, 12, 17)
Title
Measurements
OG000285± 97
OG001574± 274
OG002564± 121
OG003473± 191
OG004411± 259
OG005455± 212
Month 6 (N = 4, 4, 2, 8, 11, 15)
Title
Measurements
OG000456± 175
OG001514± 195
OG002606± 120
OG003
Month 12 (N = 4, 4, 2, 3, 6, 7)
Title
Measurements
OG000618± 285
OG001607± 326
OG002556± 65
OG003
OG004
Participants From A5271022 - Lersivirine 1000 mg Arm
Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
OG005
Participants From A5271022 - Etravirine 200 mg Arm
Participants who had received etravirine 200 mg twice daily in A5271022 parent study