Back to resultsPregabalin Trial In HIV Neuropathic Pain
Primary Purpose
HIV-1 Infection, Neuropathic Pain
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pregabalin (Lyrica)
Sponsored by
About this trial
This is an interventional treatment trial for HIV-1 Infection focused on measuring peripheral neuropathic pain, pregabalin, safety
Eligibility Criteria
Inclusion Criteria:
- Subjects who participated in the preceding A0081244 double-blind trial and completed at least through Visit 9 of that trial.
Subjects with painful distal sensory polyneuropathy (DSP) interested in treatment based on investigator's clinical judgment.
Subjects who had acceptable tolerability of study drug in A0081244.
Exclusion Criteria:
- Clinically significant or unstable conditions that, in the opinion of the investigator, would compromise participation in the study. This includes, for example, medical conditions such as, but not limited to: hepatic, renal, respiratory, hematological, immunological, cardiovascular diseases, arrhythmia, inflammatory or rheumatologic disease, active infections, symptomatic peripheral vascular disease, psychiatric illness, and untreated endocrine disorders.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Active Acquired Immune Deficiency Syndrome (AIDS)- defining Opportunistic Infection (OI) that requires hospitalization.
Sites / Locations
- Southwest Center for HIV/AIDS
- Arizona Research Center
- Providence Clinical Research
- Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical Group
- Desert Medical Group, Inc., dba Desert Oasis Helathcare Medical Group
- University of California San Diego
- Stanford University Medical Center
- Neuroscience Consultants, LLC
- South Florida Medical Research
- Mount Sinai School of Medicine
- Riesgo de Fractura S.A.
- Asistencia Cientifica de Alta Complejidad
- Surakshaka Multispeciality Hospital
- Infectious Disease Clinic
- Deenanath Mangeshkar Hospital and Research Centre
- Hospital Nacional Dos de Mayo
- RCMI-Clinical Research Center
- MediSynergy
- Worthwhile Clinical Trials (WWCT), Lake View Hospital
- Toga Laboratory
- Drs Essack and Mitha
- Pretoria West Hospital
- Dr J. Reddy's Surgery
- University of Cape Town
- Synapta Clinical Research Centre
- Paarl Research Center
- Be Part Yoluntu Centre
- South East Asia Research Collaboration with Hawaii
- Neurology unit, Department of Medicine,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pregabalin (Lyrica)
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Secondary Outcome Measures
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a Human Immunodeficiency Virus (HIV) neuropathy pain. Number of participants who responded "Yes/No" to Question 1: Are you currently employed (working for pay)? are reported.
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days.
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).
36-Item Short-Form Health Survey (SF-36)
SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).
Visual Analogue Scale for Pain (VAS-pain)
Participants rated the severity of HIV neuropathy pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
PGI-C: participant rated instrument to measure participant's change in overall status since the start of the study, on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated "Over past 2 weeks, how often bothered by any of following problems?": little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual(8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.
Full Information
NCT ID
NCT01145417
First Posted
June 7, 2010
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01145417
Brief Title
Pregabalin Trial In HIV Neuropathic Pain
Official Title
An Open-Label, Extension Safety Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081251)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study examines the safety of pregabalin over a 6 month period in patients with neuropathic pain associated with HIV infection as an extension of another trial that tests the efficacy of pregabalin.
Detailed Description
The parent double blind study was stopped at interim analysis due to lack of efficacy and therefore this open label extension study was also terminated simultaneously on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection, Neuropathic Pain
Keywords
peripheral neuropathic pain, pregabalin, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregabalin (Lyrica)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pregabalin (Lyrica)
Intervention Description
150 mg-600 mg/day (twice daily)
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame
Baseline up to 30 days after last dose of study treatment
Secondary Outcome Measure Information:
Title
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Description
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a Human Immunodeficiency Virus (HIV) neuropathy pain. Number of participants who responded "Yes/No" to Question 1: Are you currently employed (working for pay)? are reported.
Time Frame
Baseline, Week 24
Title
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Description
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days.
Time Frame
Baseline, Week 24
Title
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
Description
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).
Time Frame
Baseline, Week 24
Title
36-Item Short-Form Health Survey (SF-36)
Description
SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).
Time Frame
Baseline, Week 24
Title
Visual Analogue Scale for Pain (VAS-pain)
Description
Participants rated the severity of HIV neuropathy pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24
Title
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Description
PGI-C: participant rated instrument to measure participant's change in overall status since the start of the study, on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
Time Frame
Week 24
Title
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
Description
S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.
Time Frame
Baseline up to Week 25
Title
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
Description
PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated "Over past 2 weeks, how often bothered by any of following problems?": little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual(8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who participated in the preceding A0081244 double-blind trial and completed at least through Visit 9 of that trial.
Subjects with painful distal sensory polyneuropathy (DSP) interested in treatment based on investigator's clinical judgment.
Subjects who had acceptable tolerability of study drug in A0081244.
Exclusion Criteria:
Clinically significant or unstable conditions that, in the opinion of the investigator, would compromise participation in the study. This includes, for example, medical conditions such as, but not limited to: hepatic, renal, respiratory, hematological, immunological, cardiovascular diseases, arrhythmia, inflammatory or rheumatologic disease, active infections, symptomatic peripheral vascular disease, psychiatric illness, and untreated endocrine disorders.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Active Acquired Immune Deficiency Syndrome (AIDS)- defining Opportunistic Infection (OI) that requires hospitalization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Southwest Center for HIV/AIDS
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical Group
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Desert Medical Group, Inc., dba Desert Oasis Helathcare Medical Group
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Neuroscience Consultants, LLC
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Riesgo de Fractura S.A.
City
Bogota D.C.
State/Province
Cundinamarca
Country
Colombia
Facility Name
Asistencia Cientifica de Alta Complejidad
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Surakshaka Multispeciality Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 072
Country
India
Facility Name
Infectious Disease Clinic
City
Ahemdabad
State/Province
Gujarat
ZIP/Postal Code
380 009
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 004
Country
India
Facility Name
Hospital Nacional Dos de Mayo
City
Lima
ZIP/Postal Code
L 01
Country
Peru
Facility Name
RCMI-Clinical Research Center
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
MediSynergy
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6065
Country
South Africa
Facility Name
Worthwhile Clinical Trials (WWCT), Lake View Hospital
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Toga Laboratory
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1610
Country
South Africa
Facility Name
Drs Essack and Mitha
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2113
Country
South Africa
Facility Name
Pretoria West Hospital
City
Pretoria West
State/Province
Gauteng
ZIP/Postal Code
0117
Country
South Africa
Facility Name
Dr J. Reddy's Surgery
City
Stanger
State/Province
KwaZulu Natal
ZIP/Postal Code
4450
Country
South Africa
Facility Name
University of Cape Town
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Synapta Clinical Research Centre
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Paarl Research Center
City
Paarl
ZIP/Postal Code
7626
Country
South Africa
Facility Name
Be Part Yoluntu Centre
City
Paarl
ZIP/Postal Code
7646
Country
South Africa
Facility Name
South East Asia Research Collaboration with Hawaii
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Neurology unit, Department of Medicine,
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
24907403
Citation
Simpson DM, Rice AS, Emir B, Landen J, Semel D, Chew ML, Sporn J. A randomized, double-blind, placebo-controlled trial and open-label extension study to evaluate the efficacy and safety of pregabalin in the treatment of neuropathic pain associated with human immunodeficiency virus neuropathy. Pain. 2014 Oct;155(10):1943-54. doi: 10.1016/j.pain.2014.05.027. Epub 2014 Jun 4.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081251&StudyName=Pregabalin%20Trial%20In%20HIV%20Neuropathic%20Pain
Description
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Pregabalin Trial In HIV Neuropathic Pain
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