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| Name | Class |
|---|---|
| Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Duloxetine 60 mg, 1 tablet/day |
|
| B | No Intervention | To continue with the antidepressive treatment if exist |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine 60 mg, QD | Drug | Duloxetine 60 mg, 1 table/day, 1 year |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Negredo Eugenia, MD,PhD | Lluita contra la Sida Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias i Pujol Hospital | Badalona | Barcelona | 08916 | Spain |
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| 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 |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D015673 | Fatigue Syndrome, Chronic |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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