Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+
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|ClinicalTrials.gov Identifier: NCT00552682|
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : July 21, 2009
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia HIV-1 Infection||Drug: Duloxetine 60 mg, QD||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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+|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552682
|Germans Trias i Pujol Hospital|
|Badalona, Barcelona, Spain, 08916|
|Principal Investigator:||Negredo Eugenia, MD,PhD||Lluita contra la Sida Foundation|