Pregabalin Trial In HIV Neuropathic Pain

Phase 3

Terminated

Conditions: HIV-1 Infection
Neuropathic Pain

Interventions: Drug: pregabalin (Lyrica)

Registration Number: NCT01145417

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 217

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregabalin (Lyrica)	pregabalin (Lyrica)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to 30 days after last dose of study treatment	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

Name	Time	Method
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)	Week 24	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 Patient Health Questionnaire-8 (PHQ-8)	Baseline	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.
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire	Baseline, Week 24	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.
36-Item Short-Form Health Survey (SF-36)	Baseline, Week 24	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).
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire	Baseline, Week 24	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.
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire	Baseline, Week 24	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).
Visual Analogue Scale for Pain (VAS-pain)	Baseline, Week 4, 8, 12, 16, 20, 24	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 Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories	Baseline up to Week 25	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.

Trial Locations

Locations (29): Deenanath Mangeshkar Hospital and Research Centre
🇮🇳
Pune, Maharashtra, India
Hospital Nacional Dos de Mayo
🇵🇪
Lima, Peru
RCMI-Clinical Research Center
🇵🇷
Rio Piedras, Puerto Rico
MediSynergy
🇿🇦
Port Elizabeth, Eastern Cape, South Africa
Infectious Disease Clinic
🇮🇳
Ahemdabad, Gujarat, India
Toga Laboratory
🇿🇦
Johannesburg, Gauteng, South Africa
Providence Clinical Research
🇺🇸
Burbank, California, United States
Southwest Center for HIV/AIDS
🇺🇸
Phoenix, Arizona, United States
Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical Group
🇺🇸
Palm Springs, California, United States
Neuroscience Consultants, LLC
🇺🇸
Aventura, Florida, United States
Stanford University Medical Center
🇺🇸
Stanford, California, United States
University of California San Diego
🇺🇸
San Diego, California, United States
Desert Medical Group, Inc., dba Desert Oasis Helathcare Medical Group
🇺🇸
Palm Springs, California, United States
South Florida Medical Research
🇺🇸
Aventura, Florida, United States
Asistencia Cientifica de Alta Complejidad
🇨🇴
Bogota, Cundinamarca, Colombia
Mount Sinai School of Medicine
🇺🇸
New York, New York, United States
Riesgo de Fractura S.A.
🇨🇴
Bogota D.C., Cundinamarca, Colombia
Surakshaka Multispeciality Hospital
🇮🇳
Hyderabad, Andhra Pradesh, India
Worthwhile Clinical Trials (WWCT), Lake View Hospital
🇿🇦
Benoni, Gauteng, South Africa
Drs Essack and Mitha
🇿🇦
Johannesburg, Gauteng, South Africa
Pretoria West Hospital
🇿🇦
Pretoria West, Gauteng, South Africa
University of Cape Town
🇿🇦
Cape Town, Western Cape, South Africa
Dr J. Reddy's Surgery
🇿🇦
Stanger, KwaZulu Natal, South Africa
Synapta Clinical Research Centre
🇿🇦
Durban, South Africa
Neurology unit, Department of Medicine,
🇹🇭
Bangkok, Thailand
Paarl Research Center
🇿🇦
Paarl, South Africa
Be Part Yoluntu Centre
🇿🇦
Paarl, South Africa
South East Asia Research Collaboration with Hawaii
🇹🇭
Bangkok, Thailand