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
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare duloxetine with conventional treatment of pain in HIV-1 infected patients.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborators:
Fundacio Lluita Contra la SIDA
FundaciĆ³n FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la PromociĆ³n de la Salud y la Ciencia
Treatments:
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.