Back to results

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

Primary Purpose

Fibromyalgia, HIV-1 Infection

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Duloxetine 60 mg, QD

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring HIV, fibromialgy, chronic fatigue syndrome, duloxetine, pain, treatment experienced, Fibromialgy in patients with HIV-1 infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Germans Trias i Pujol Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

Duloxetine 60 mg, 1 tablet/day

To continue with the antidepressive treatment if exist

Outcomes

Primary Outcome Measures

Variation in pain measured using the Brief Pain Inventory questionnaire in both branches of the study

Secondary Outcome Measures

Assess differences in Short-Form 36 Health Survey (SF-36) questionnaire scale score.

Assess differences in Beck Depression Inventory (BDI) questionnaire scale score.

Assess differences in Profile of Mood States - Forma A (POMS-A) questionnaire scale score.

Assess the percentage of patients that leave duloxetine due to intolerance or toxicity.

Assess, if possible, pharmacokinetic profile of duloxetine and determine interaction with antiretroviral drugs.

Full Information

NCT ID

NCT00552682

First Posted

October 31, 2007

Last Updated

December 3, 2019

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

1. Study Identification

Unique Protocol Identification Number

NCT00552682

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the 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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia, HIV-1 Infection

Keywords

HIV, fibromialgy, chronic fatigue syndrome, duloxetine, pain, treatment experienced, Fibromialgy in patients with HIV-1 infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Duloxetine 60 mg, 1 tablet/day

Arm Title

Arm Type

No Intervention

Arm Description

To continue with the antidepressive treatment if exist

Intervention Type

Drug

Intervention Name(s)

Duloxetine 60 mg, QD

Other Intervention Name(s)

Xeristar

Intervention Description

Duloxetine 60 mg, 1 table/day, 1 year

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Assess differences in Short-Form 36 Health Survey (SF-36) questionnaire scale score.

Time Frame

basal visit, weeks 12, 24 and 48

Title

Assess differences in Beck Depression Inventory (BDI) questionnaire scale score.

Time Frame

basal visit, weeks 12, 24 and 48

Title

Assess differences in Profile of Mood States - Forma A (POMS-A) questionnaire scale score.

Time Frame

basal visit, weeks 12, 24 and 48

Title

Assess the percentage of patients that leave duloxetine due to intolerance or toxicity.

Time Frame

basal visit, weeks 4, 12, 24, 36 and 48

Title

Assess, if possible, pharmacokinetic profile of duloxetine and determine interaction with antiretroviral drugs.

Time Frame

basal visit, weeks 4, 12, 24, 36 and 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged 18 years old and more. Age +18 years old. Documented HIV-1-infection. Former diagnosis of fibromialgy. History of good compliance with visit schedule and medication intake. Patients voluntary signed the informed consent. Exclusion Criteria: Pregnant or breast-feeding females Suspicion of intolerance to duloxetine. History of any clinical condition that, in the Investigator's criteria, could potentially reoccur with the suggested change of therapy (sarcoma, lymphoma, etc). Concomitant condition that could mimic fibromialgy (lupus, endocrine diseases, muscular diseases, multiple sclerosis) or Acute illness within 15 days prior to the inclusion 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) Anorexia or nervous bulimia History or suspected drug or alcohol abuse. Glaucoma History of heart disease including cardiac arrhythmias Severe obesity (body mass index > 45). Concomitant medication with IMAOS, cimetidine or quinolonas Patients with hepatic or renal serious failure (Creatinin clearance <30 ml/min) Patients with Hypericum perforatum as a concomitant treatment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Negredo Eugenia, MD,PhD

Organizational Affiliation

Lluita contra la Sida Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Germans Trias i Pujol Hospital

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs