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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00552682
• Date of registration: 31/10/2007
• Primary sponsor: Germans Trias i Pujol Hospital
• Public title: Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+
• Scientific title: Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+
• Date of first enrolment: January 2007
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00552682
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Spain

Contacts

• Name: Negredo Eugenia, MD,PhD
• Affiliation: Lluita contra la Sida Foundation

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fibromyalgia

HIV-1 Infection

Intervention(s)

Drug: Duloxetine 60 mg, QD

Primary Outcome(s)

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(s)

Assess differences in Beck Depression Inventory (BDI) questionnaire scale score. [Time Frame: basal visit, weeks 12, 24 and 48]

Assess differences in Profile of Mood States - Forma A (POMS-A) questionnaire scale score. [Time Frame: basal visit, weeks 12, 24 and 48]

Assess differences in Short-Form 36 Health Survey (SF-36) questionnaire scale score. [Time Frame: basal visit, weeks 12, 24 and 48]

Assess the percentage of patients that leave duloxetine due to intolerance or toxicity. [Time Frame: basal visit, weeks 4, 12, 24, 36 and 48]

Assess, if possible, pharmacokinetic profile of duloxetine and determine interaction with antiretroviral drugs. [Time Frame: basal visit, weeks 4, 12, 24, 36 and 48]

Secondary ID(s)

FIBROHIV

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fundacio Lluita Contra la SIDA