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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; HIV-1 Infection
• Intervention / Treatment: Drug: Duloxetine 60 mg, QD

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Germans Trias I Pujol Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Xeristar
No Intervention: B; To continue with the antidepressive treatment if exist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Germans Trias i Pujol Hospital
• Collaborators: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: October 31, 2007
• First Submitted That Met QC Criteria: November 1, 2007
• First Posted (Estimate): November 2, 2007

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: pain; HIV; chronic fatigue syndrome; treatment experienced; duloxetine; fibromialgy; Fibromialgy in patients with HIV-1 infection
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease Attributes; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Infections; Communicable Diseases; Fibromyalgia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: FIBROHIV