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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+
This study has been completed.
Sponsor:
Germans Trias i Pujol Hospital
Collaborator:
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00552682
First received: October 31, 2007
Last updated: July 20, 2009
Last verified: July 2009
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Purpose
The purpose of this study is to compare duloxetine with conventional treatment of pain in HIV-1 infected patients.
| Condition | Intervention | Phase |
|---|---|---|
| Fibromyalgia HIV-1 Infection | Drug: Duloxetine 60 mg, QD | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+ |
Resource links provided by NLM:
Further study details as provided by Germans Trias i Pujol Hospital:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 10 |
| Study Start Date: | January 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Duloxetine 60 mg, 1 tablet/day
|
Drug: Duloxetine 60 mg, QD
Duloxetine 60 mg, 1 table/day, 1 year
Other Name: Xeristar
|
|
No Intervention: B
To continue with the antidepressive treatment if exist
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00552682
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552682
Locations
| Spain | |
| Germans Trias i Pujol Hospital | |
| Badalona, Barcelona, Spain, 08916 | |
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Investigators
| Principal Investigator: | Negredo Eugenia, MD,PhD | Lluita contra la Sida Foundation |
More Information
| Responsible Party: | LLuita Sida Foundation |
| ClinicalTrials.gov Identifier: | NCT00552682 History of Changes |
| Other Study ID Numbers: |
FIBROHIV |
| Study First Received: | October 31, 2007 |
| Last Updated: | July 20, 2009 |
Keywords provided by Germans Trias i Pujol Hospital:
|
HIV fibromialgy chronic fatigue syndrome duloxetine |
pain treatment experienced Fibromialgy in patients with HIV-1 infection |
Additional relevant MeSH terms:
|
Infection Communicable Diseases Fibromyalgia Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Duloxetine Hydrochloride Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents |
ClinicalTrials.gov processed this record on August 18, 2017