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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+

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ClinicalTrials.gov Identifier: NCT00552682
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : July 21, 2009
Sponsor:
Collaborator:
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital

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

Condition or disease Intervention/treatment Phase
Fibromyalgia HIV-1 Infection Drug: Duloxetine 60 mg, QD Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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+
Study Start Date : January 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Assess differences in Short-Form 36 Health Survey (SF-36) questionnaire scale score. [ Time Frame: basal visit, weeks 12, 24 and 48 ]
  2. Assess differences in Beck Depression Inventory (BDI) questionnaire scale score. [ Time Frame: basal visit, weeks 12, 24 and 48 ]
  3. Assess differences in Profile of Mood States - Forma A (POMS-A) questionnaire scale score. [ Time Frame: basal visit, weeks 12, 24 and 48 ]
  4. Assess the percentage of patients that leave duloxetine due to intolerance or toxicity. [ Time Frame: basal visit, weeks 4, 12, 24, 36 and 48 ]
  5. Assess, if possible, pharmacokinetic profile of duloxetine and determine interaction with antiretroviral drugs. [ Time Frame: basal visit, weeks 4, 12, 24, 36 and 48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18 years old and more. Age +18 years old.
  2. Documented HIV-1-infection.
  3. Former diagnosis of fibromialgy.
  4. History of good compliance with visit schedule and medication intake.
  5. Patients voluntary signed the informed consent.

Exclusion Criteria:

  1. Pregnant or breast-feeding females
  2. Suspicion of intolerance to duloxetine.
  3. History of any clinical condition that, in the Investigator's criteria, could potentially reoccur with the suggested change of therapy (sarcoma, lymphoma, etc).
  4. Concomitant condition that could mimic fibromialgy (lupus, endocrine diseases, muscular diseases, multiple sclerosis)
  5. or Acute illness within 15 days prior to the inclusion
  6. 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)
  7. Anorexia or nervous bulimia
  8. History or suspected drug or alcohol abuse.
  9. Glaucoma
  10. History of heart disease including cardiac arrhythmias
  11. Severe obesity (body mass index > 45).
  12. Concomitant medication with IMAOS, cimetidine or quinolonas
  13. Patients with hepatic or renal serious failure (Creatinin clearance <30 ml/min)
  14. Patients with Hypericum perforatum as a concomitant treatment.
Contacts and Locations
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Information from the National Library of Medicine

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


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
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Responsible Party: LLuita Sida Foundation
ClinicalTrials.gov Identifier: NCT00552682     History of Changes
Other Study ID Numbers: FIBROHIV
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: July 21, 2009
Last Verified: July 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