Overview
Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+
Status:
Completed
Completed
Trial end date:
2009-07-01
2009-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to compare duloxetine with conventional treatment of pain in HIV-1 infected patients.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Germans Trias i Pujol HospitalCollaborators:
Fundacio Lluita Contra la SIDA
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaTreatments:
Duloxetine Hydrochloride
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.