Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+

Fibromyalgia Clinical Trial

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+

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552682
• Other study ID #: FIBROHIV
• Status: Completed
• Phase: Phase 3
• Start date: January 2007
• Est. completion date: July 2009

Study information

• Verified date: December 2019
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Fibromyalgia
• HIV-1 Infection
• Infection

Intervention

Drug:
• Duloxetine 60 mg, QD
Duloxetine 60 mg, 1 table/day, 1 year

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol Hospital	Badalona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital	Fundacio Lluita Contra la SIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Assess differences in Short-Form 36 Health Survey (SF-36) questionnaire scale score.		basal visit, weeks 12, 24 and 48
Secondary	Assess differences in Beck Depression Inventory (BDI) questionnaire scale score.		basal visit, weeks 12, 24 and 48
Secondary	Assess differences in Profile of Mood States - Forma A (POMS-A) questionnaire scale score.		basal visit, weeks 12, 24 and 48
Secondary	Assess the percentage of patients that leave duloxetine due to intolerance or toxicity.		basal visit, weeks 4, 12, 24, 36 and 48
Secondary	Assess, if possible, pharmacokinetic profile of duloxetine and determine interaction with antiretroviral drugs.		basal visit, weeks 4, 12, 24, 36 and 48