The purpose of this study is to compare duloxetine with conventional treatment of pain in HIV-1 infected patients.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Duloxetine 60 mg, 1 table/day, 1 year
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain
Variation in pain measured using the Brief Pain Inventory questionnaire in both branches of the study
Time frame: Time frame: basal visit, weeks 4, 12, 24, 36 and 48
Assess differences in Short-Form 36 Health Survey (SF-36) questionnaire scale score.
Time frame: basal visit, weeks 12, 24 and 48
Assess differences in Beck Depression Inventory (BDI) questionnaire scale score.
Time frame: basal visit, weeks 12, 24 and 48
Assess differences in Profile of Mood States - Forma A (POMS-A) questionnaire scale score.
Time frame: basal visit, weeks 12, 24 and 48
Assess the percentage of patients that leave duloxetine due to intolerance or toxicity.
Time frame: basal visit, weeks 4, 12, 24, 36 and 48
Assess, if possible, pharmacokinetic profile of duloxetine and determine interaction with antiretroviral drugs.
Time frame: basal visit, weeks 4, 12, 24, 36 and 48
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