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

Purpose

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

Condition	Intervention	Phase
Fibromyalgia HIV-1 Infection	Drug: Duloxetine 60 mg, QD	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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+

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Enrollment:	10
Study Start Date:	January 2007
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Duloxetine 60 mg, 1 tablet/day	Drug: Duloxetine 60 mg, QD Duloxetine 60 mg, 1 table/day, 1 year Other Name: Xeristar
No Intervention: B To continue with the antidepressive treatment if exist

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.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552682

Locations


Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916

Sponsors and Collaborators

Germans Trias i Pujol Hospital

Fundacio Lluita Contra la SIDA

Investigators


Principal Investigator:	Negredo Eugenia, MD,PhD	Lluita contra la Sida Foundation

More Information


Responsible Party:	LLuita Sida Foundation
ClinicalTrials.gov Identifier:	NCT00552682 History of Changes
Other Study ID Numbers:	FIBROHIV
Study First Received:	October 31, 2007
Last Updated:	July 20, 2009
Health Authority:	Spain: Ministry of Health

Keywords provided by Germans Trias i Pujol Hospital:


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

Additional relevant MeSH terms:


Infection Communicable Diseases Fibromyalgia Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Duloxetine Hydrochloride Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors	Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents

ClinicalTrials.gov processed this record on September 26, 2016