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

NCT ID: NCT00552682

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-07-31

Brief Summary

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

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.

Conditions

Fibromyalgia; HIV-1 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Duloxetine 60 mg, 1 tablet/day

Group Type: EXPERIMENTAL

Duloxetine 60 mg, QD

Intervention Type: DRUG

Duloxetine 60 mg, 1 table/day, 1 year

B

To continue with the antidepressive treatment if exist

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Duloxetine 60 mg, QD

Duloxetine 60 mg, 1 table/day, 1 year

Intervention Type: DRUG

Other Intervention Names

Xeristar

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

OTHER

Sponsor Role: collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Negredo Eugenia, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Lluita contra la Sida Foundation

Locations

Germans Trias i Pujol Hospital

Badalona, Barcelona, Spain

Countries

Spain

Other Identifiers

FIBROHIV

Identifier Type: -

Identifier Source: org_study_id