Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial Of Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081244)

The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.

Study Overview

• Status: Terminated
• Conditions: Neuropathy
• Intervention / Treatment: Drug: pregabalin; Drug: placebo

Detailed Description

Based on DMC interim efficacy analysis results indicating a low probability for success the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.

• Study Type: Interventional
• Enrollment (Actual): 377
• Phase: Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 0000
      • Asistencia Cientifica de Alta Complejidad
    • Bogota, Cundinamarca, Colombia
      • Centro Instituto de Investigaciones Fundación Universitaria Sanitas
    • Bogotá, Cundinamarca, Colombia, 0000
      • Riesgo De Fractura S.A
  • Santander
    • Bucaramanga, Santander, Colombia, 0000
      • Instituto Colombiano para el Avance de la Medicina- Santander S.A.S. - ICAMEDIC Santander S.A.S
• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Instituto Dominicano de Estudios Virologicos - IDEV
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500 004
      • Mahavir Hospital and Research Centre
    • Hyderabad, Andhra Pradesh, India, 500 072
      • Surakshaka Multispeciality Hospital
  • Gujarat
    • Ahmedabad, Gujarat, India, 380 009
      • Infectious disease clinic
  • Maharashtra
    • Mumbai, Maharashtra, India, 400026
      • Jaslok Hospital & Research Centre
    • Pune, Maharashtra, India, 411 004
      • Deenanath Mangeshkar Hospital and Research Centre
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 113
      • YR Gaitonde Centre for AIDS Research and Education
• Peru
  • Lima, Peru, L 01
    • Hospital Nacional Dos de Mayo
  • Lima, Peru, L 13
    • Hospital Nacional Guillermo Almenara Irigoyen
• Poland
  • Bydgoszcz, Poland, 85-030
    • Katedra Chorob Zakaznych i Hepatologii UMK w Toruniu CM w Bydgoszczy
  • Chorzow, Poland, 41-500
    • Oddzial Diagnostyki i Terapii AIDS
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce School of Medicine-CAIMED Center
  • Ponce, Puerto Rico, 00732-7004
    • Ponce School of Medicine - Practice Group
  • Rio Piedras, Puerto Rico, 00935
    • Puerto Rico Clinical and Translational Research Consortium
• South Africa
  • Durban, South Africa, 4001
    • Synapta Clinical Research Centre
  • Gauteng, South Africa, 2047
    • Innovir Institute
  • Middelburg, South Africa, 1050
    • Mzansi Ethical Research Centre
  • Paarl, South Africa, 7626
    • Be Part Yoluntu Centre
  • Paarl, South Africa, 7646
    • Paarl Research Center
  • Pretoria, South Africa, 0002
    • Clinical Research Unit, University of Pretoria
  • Tygerberg, South Africa, 7505
    • Department of Neurology
  • Eastern Cape
    • East London, Eastern Cape, South Africa, 5200
      • Border Diabetic Centre
    • Port Elizabeth, Eastern Cape, South Africa, 6065
      • MediSynergy
  • Gauteng
    • Benoni, Gauteng, South Africa, 1500
      • Worthwhile Clinical Trials
    • Johannesburg, Gauteng, South Africa, 1610
      • Toga Laboratory
    • Johannesburg, Gauteng, South Africa, 2113
      • Drs Essack and Mitha
    • Johannesburg, Gauteng, South Africa, 2193
      • University of Witwatersrand-Clinical HIV Research Unit (CHRU)
    • Pretoria, Gauteng, South Africa, 0122
      • Synexus SA Stanza Bopape Clinical Research Centre
    • Pretoria West, Gauteng, South Africa, 0117
      • Pretoria West Hospital
    • Soweto, Gauteng, South Africa, 1808
      • Chris Hani Baragwanath Hospital, The Palliative Care Centre
  • KwaZulu Natal
    • Stanger, KwaZulu Natal, South Africa, 4450
      • Dr J. Reddy's Surgery
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7925
      • University of Cape Town
• Thailand
  • Bangkok, Thailand, 10330
    • South East Asia Research Collaboration with Hawaii
  • Bangkok, Thailand, 10400
    • Neurology unit, Department of Medicine,
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
    • Phoenix, Arizona, United States, 85006
      • Southwest Center For Hiv/Aids
    • Phoenix, Arizona, United States, 85006
      • SW Center for HIV/AIDS
  • California
    • Los Angeles, California, United States, 90015
      • AIDS Research Alliance of America
    • Los Angeles, California, United States, 90069
      • Anthony Mills, MD, Inc.
    • Los Angeles, California, United States, 90095
      • David Geffen School of Medicine at UCLA c/o NNAB
    • North Hollywood, California, United States, 91606
      • Providence Clinical Research
    • Palm Springs, California, United States, 92262
      • Desert Medical Group, Inc. dba Desert Oasis Healthcare Medical Group
    • San Diego, California, United States, 92103
      • University of California San Diego
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Aventura, Florida, United States, 33180
      • Neuroscience Consultants, LLC.
    • Miami, Florida, United States, 33133
      • The Kinder Medical Group
    • Miami Beach, Florida, United States, 33139
      • Wohlfeiler, Piperato & Associates, LLC
    • Tampa, Florida, United States, 33606
      • Meridien Research
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • AIDS Research Consortium of Atlanta
    • Atlanta, Georgia, United States, 30312
      • Midtown Neurology, PC
    • Decatur, Georgia, United States, 30033
      • Neurology Specialists of Decatur Research Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Rehabilitation Institute of Chicago
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • Ohio
    • Toledo, Ohio, United States, 43614
      • University of Toledo
    • Toledo, Ohio, United States, 43614
      • University of Toledo Medical Center
  • Texas
    • Bellaire, Texas, United States, 77401
      • University of Texas Physicians
    • Dallas, Texas, United States, 75235
      • Amelia Court Hiv Research Clinic
    • Houston, Texas, United States, 77030
      • The University of Texas Medical School at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women, ages of 18 or greater
• Documented evidence of HIV-1 infection
• Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain
• Pain starts in the feet

Exclusion Criteria:

• Subject has untreated vitamin B12 deficiency (serum B12 level <200 pg/ml) or if treated B12 deficiency -treatment is less than 6 months of B12 supplementation (injection or intranasal B12) prior to screening
• Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C >6.9
• Subjects with peripheral neuropathic pain that is not associated with HIV infection; including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Drug: placebo; Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.
Experimental: Active drug	Drug: pregabalin; Pregabalin 75 mg-300mg twice daily during the course of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Pain Score at Endpoint (up to Week 16)	Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward (mBOCF).	Baseline, Endpoint (up to Week 16)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC)	PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category is reported.	Week 16
Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC)	The CGIC scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGIC). At final visit, the participants CGIC will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse. Number of participants in each category is reported.	Week 16
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)	Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how HIV neuropathy pain has interfered with their sleep during the past 24 hours on an 11-point NRS ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). Endpoint was the last observation for a participant assessed using specified imputation method.	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)	Weekly current pain score was defined as the mean of the daily current pain diary ratings split into 7 day intervals. Participants rated current ("right now") HIV neuropathy pain an 11-point NRS ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method.	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16)	BPI-sf:5-item self-administered questionnaire to assess severity,impact of pain on daily functions. Pain Severity Index (PSI):average of Question 1-4 each measured severity of pain over past 24-hours on 11-point scale (0=no pain to 10=worst possible pain). Pain Interference Index (PII):average of 7 pain interference items of Question 5 that measured level of interference of pain on daily function on 11-point scale (0=does not interfere to 10=completely interferes). For PSI, PII range:0-10 higher score=higher pain/interference. Endpoint=last observation for participant as per imputation method.	Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16)
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16)	NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors and 2 temporal items. Results reported for the 10 descriptors (burning, squeezing, pressure, electric shocks, stabbing, light touching of area, pressure of area, cold of area, pins and needles, tingling) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) scale. Endpoint was the last observation for a participant assessed using specified imputation method.	Baseline, Endpoint (up to Week 16)
Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16)	NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors, and 2 temporal items. Results reported for categorical change in temporal items assessed on 5-point scale for duration of spontaneous pain (1=continuously, 2=8-12 hours [hrs], 3=4-7 hrs, 4=1-3 hrs, 5=less than 1 hr), numbers of pain attacks (1=more than 20, 2=11-20 attacks, 3=6-10 attacks, 4=1-5 attacks, 5=no attack). Change data categorized as worsened (negative change), unchanged (no change), and improved (positive change). Endpoint=last observation as per imputation method.	Baseline, Endpoint (up to Week 16)
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16)	NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (subscales: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. The relevant subscales and total score were transformed to 0-1, higher score indicates a greater intensity of pain. Endpoint=last observation for participant as per imputation method.	Baseline, Endpoint (up to Week 16)
Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS)	Total sleep time is the number of minutes asleep between time of sleep onset to morning awakening and MIS is the number of minutes spent awake after sleep onset to final awakening. TST and MIS were determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.	Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
Sleep Fragmentation Index (SFI)	SFI is a measure to quantify sleep restlessness. SFI calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. SFI determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on wrist like a watch. It was programmed to record movements while device was being worn. Endpoint was the last observation for a participant assessed using imputation method.	Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
Sleep Efficiency	Sleep efficiency is the time spent asleep divided by total time between sleep onset and sleep end, multiplied by 100. Sleep efficiency was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.	Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
Total Activity Counts	Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the "day" (non sleep period). A total activity count was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.	Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
Percentage Day Time Above Sedentary Level	Percentage of time above sedentary level is number of epochs (60 seconds) with greater than (>) 200 activity counts per minute divided by total number of epochs during the "day" (non sleep period) multiplied by 100. This was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.	Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16)	Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. Endpoint was the last observation for a participant assessed using imputation method.	Baseline, Endpoint (up to Week 16)
Medical Outcomes Study-Sleep Scale (MOS-SS): Number of Participants With Optimal Sleep	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Endpoint was the last observation for a participant assessed using imputation method.	Baseline, Endpoint (up to Week 16)
Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16)	HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Endpoint was the last observation for a participant assessed using imputation method.	Baseline, Endpoint (up to Week 16)
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16)	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).	Baseline, Endpoint (up to Week 16)
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 specific health problem (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. Number of participants who responded "Yes/No" to Question 1: Are you currently employed (working for pay)? are reported.	Baseline, Week 16, 17
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. A participant who had responded 'no' to question 1 regarding employment status reported hours of work and as this was a self-reported questionnaire the source data were included.	Baseline, Week 16, 17
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).	Baseline, Week 16, 17
Diagnostic Neuropathy Assessment		Screening

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent (TE) Adverse Events (AEs) or 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 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.	Baseline up to 28 days after last dose
Number of Participants With Abnormal Laboratory Test Findings	Laboratory tests included hematology, chemistry, cluster of differentiation 4 (CD4) count and cluster of differentiation 8 (CD8) count, HIV plasma viral load, B12, Venereal Disease Research Laboratory (VDRL), toxic screens for drugs and alcohol, reflex thyroid-stimulating hormone (TSH), urinalysis. Number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time was reported.	Screening up to Week 17
Number of Participants With Positive Serum and Urine Pregnancy	Serum pregnancy test (regardless of childbearing potential) and urine pregnancy test for all female participants were performed.	Screening for serum pregnancy test, Week 1 for urine pregnancy test
Number of Participants With Abnormal Physical Examination Findings	A physical examination included an examination of the general appearance, skin, chest, pulses, pulmonary, cardiovascular, head, eyes, ears, nose, throat, abdominal, and extremities.	Screening, Week 8, 17
Body Weight		Screening, Week 1, 4, 8, 12, 16, 17
Sitting Systolic and Diastolic Blood Pressure	Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.	Screening, Week 1, 4, 8, 12, 16, 17
Sitting Heart Rate		Screening, Week 1, 4, 8, 12, 16, 17
Number of Participants With Neurological Examination Findings	A neurological examination consisted of examination of the mental state, cranial nerve function, motor function (reflexes of patellar, achilles, biceps, babinski and coordination) and sensory function (sharp sensation of dorsal surface of right and left great toe, light touch of lower extremities [LE], right and left first metatarsal joint position sense, and vibration sensation [vibration is felt for < 6 seconds = markedly diminished, 6 to 10 seconds = mild loss, > 10 seconds = normal]).	Screening
Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI) Criteria	MINI: short structured clinical interview to make diagnoses of psychiatric disorders according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or International Classifications of Disease-10 (ICD-10). In the MINI Modules, participants were asked a series of Yes/No questions.	Screening
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.	Screening, Post-Baseline (Week 4 up to Week 17)
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.	Screening

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: January 13, 2010
• First Submitted That Met QC Criteria: January 13, 2010
• First Posted (Estimate): January 14, 2010

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: pain; HIV-1; HIV Infections; neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Neuralgia; Peripheral Nervous System Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081244