Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+

Study Overview
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Brief Summary
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The purpose of this study is to compare duloxetine with conventional treatment of pain in HIV-1 infected patients.

Detailed Description
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Among HIV-1-infected patients, diagnosis of fibromialgy has increased over the last years . Appropriate identification of firomialgy in these patients is challenging and sometimes can be more complicated than in HIV-negative population. Concomitant infectious processes and symptoms due to HIV infection itself need to be ruled out before establishing a formal diagnosis. The treatment of this disease frequently includes muscular relaxants , pain-killers, anti-inflammatories and antidepressives despite no drug is formally indicated for this pathology. Duloxetine approved indications include both treatment of major depressive disorders (MDD) and diabetic neuropathic pain. Recent studies in HIV negative patients show efficacy to control pain and depressive symptoms in patients with fibromialgy The main purpose of this pilot study is to assess the efficacy of duloxetine in HIV-1-infected patients with fibromialgy. The main purpose of this pilot study is to assess the efficacy of duloxetine in HIV-1-infected patients with fibromialgy or chronic fatigue syndrome presenting with widespread pain.

Official Title
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Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+

Conditions
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Fibromyalgia, HIV-1 Infection

Intervention / Treatment
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* Drug: Duloxetine 60 mg, QD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years old and more. Age +18 years old. Documented HIV-1-infection. Former diagnosis of fibromialgy. History of good compliance with visit schedule and medication intake. Patients voluntary signed the informed consent. Exclusion Criteria: Pregnant or breast-feeding females Suspicion of intolerance to duloxetine. History of any clinical condition that, in the Investigator's criteria, could potentially reoccur with the suggested change of therapy (sarcoma, lymphoma, etc). Concomitant condition that could mimic fibromialgy (lupus, endocrine diseases, muscular diseases, multiple sclerosis) or Acute illness within 15 days prior to the inclusion Patients with major depressive disorder with psychotic symptoms, major depressive disorder melancholic type or bipolar disorder. Patients with other depressive disorders can be included (dysthymic disorder and depressive disorder NOS) Anorexia or nervous bulimia History or suspected drug or alcohol abuse. Glaucoma History of heart disease including cardiac arrhythmias Severe obesity (body mass index > 45). Concomitant medication with IMAOS, cimetidine or quinolonas Patients with hepatic or renal serious failure (Creatinin clearance <30 ml/min) Patients with Hypericum perforatum as a concomitant treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Duloxetine 60 mg, 1 tablet/day | Drug: Duloxetine 60 mg, QD<br>* Duloxetine 60 mg, 1 table/day, 1 year<br>* Other names: Xeristar;|
| No Intervention: B<br>To continue with the antidepressive treatment if exist | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in pain measured using the Brief Pain Inventory questionnaire in both branches of the study |  | Time frame: basal visit, weeks 4, 12, 24, 36 and 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess differences in Short-Form 36 Health Survey (SF-36) questionnaire scale score. |  | basal visit, weeks 12, 24 and 48 | 
| Assess differences in Beck Depression Inventory (BDI) questionnaire scale score. |  | basal visit, weeks 12, 24 and 48 | 
| Assess differences in Profile of Mood States - Forma A (POMS-A) questionnaire scale score. |  | basal visit, weeks 12, 24 and 48 | 
| Assess the percentage of patients that leave duloxetine due to intolerance or toxicity. |  | basal visit, weeks 4, 12, 24, 36 and 48 | 
| Assess, if possible, pharmacokinetic profile of duloxetine and determine interaction with antiretroviral drugs. |  | basal visit, weeks 4, 12, 24, 36 and 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, fibromialgy, chronic fatigue syndrome, duloxetine, pain, treatment experienced, Fibromialgy in patients with HIV-1 infection