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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:
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

October 31, 2007
July 20, 2009
January 2007
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Variation in pain measured using the Brief Pain Inventory questionnaire in both branches of the study
Complete list of historical versions of study NCT00552682 on ClinicalTrials.gov Archive Site
  • Assess differences in Short-Form 36 Health Survey (SF-36) questionnaire scale score. [ Time Frame: basal visit, weeks 12, 24 and 48 ] [ Designated as safety issue: No ]
  • Assess differences in Beck Depression Inventory (BDI) questionnaire scale score. [ Time Frame: basal visit, weeks 12, 24 and 48 ] [ Designated as safety issue: No ]
  • Assess differences in Profile of Mood States - Forma A (POMS-A) questionnaire scale score. [ Time Frame: basal visit, weeks 12, 24 and 48 ] [ Designated as safety issue: No ]
  • Assess the percentage of patients that leave duloxetine due to intolerance or toxicity. [ Time Frame: basal visit, weeks 4, 12, 24, 36 and 48 ] [ Designated as safety issue: Yes ]
  • Assess, if possible, pharmacokinetic profile of duloxetine and determine interaction with antiretroviral drugs. [ Time Frame: basal visit, weeks 4, 12, 24, 36 and 48 ] [ Designated as safety issue: Yes ]
- Assess differences in Short-Form 36 Health Survey (SF-36) questionnaire scale score at basal visit, week 12, 24 and 48. . - Assess differences in Beck Depression Inventory (BDI) questionnaire scale score at in basal visit, week 12, 24 and 48- -
Not Provided
Not Provided
 
Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+
Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Fibromyalgia
  • HIV-1 Infection
Drug: Duloxetine 60 mg, QD
Duloxetine 60 mg, 1 table/day, 1 year
Other Name: Xeristar
  • Experimental: A
    Duloxetine 60 mg, 1 tablet/day
    Intervention: Drug: Duloxetine 60 mg, QD
  • No Intervention: B
    To continue with the antidepressive treatment if exist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00552682
FIBROHIV
Yes
LLuita Sida Foundation
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Principal Investigator: Negredo Eugenia, MD,PhD Lluita contra la Sida Foundation
Germans Trias i Pujol Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP