Status:
UNKNOWN
Rosuvastatin to Decrease Residual Immune Activation in HIV Infection
Lead Sponsor:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Collaborating Sponsors:
Sidaction
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Participating countries: France Objectives Principal objective To evaluate, in HIV-1 infected patients receiving effective antiretroviral therapy, the effect of the addition of Rosuvastatin (dose of 2...
Detailed Description
Methodology Phase II pilot study; open-label; non comparative, bicentric, on-off design Estimated enrolment 40 subjects Outcomes Primary outcome : • Variation at month 3 in the proportion of CD8 T ...
Eligibility Criteria
Inclusion
- HIV-infected patients receiving a combination of antiretroviral therapy for at least 24 months, unchanged since at least 18 months, exhibiting plasma HIV-RNA level below 20 copies and circulating CD4 T cell count below 500/mm3
- No indication for a treatment with statins (LDL cholesterol \< 4.1 mmol/L under stable diet).
Exclusion
- Patients receiving Maraviroc
- Patients receiving immune suppressing drugs
- Ongoing opportunistic, bacterial or viral infection
- CRP ≥ 10 mg/mL
- Co-infection with HCV (except if HCV cure), chronic HBV infection with active replication of HBV
- Indication for a treatment with statins
- Pregnancy
- CPK \> 3x Normal values
- ALT or AST \> 2x Normal values
- TG \> 4 mmol/L
- DFG \< 60 mL /min/1.73 m2
- Personal or familial history of genetic muscular disease
- History of muscular or hepatic toxicity with a statin or a fibrate
- Liver disease (TP \< 70%).
- Hypothyroidism
- Concomitant treatment with : Kétoconazole, Itraconazole, Ciclosporine, Erythromycine, Cimétidine, Quinidine, Diltiazem, Vérapamil, systemic corticosteroids, Phénobarbital, Phénytoïne, Carbamazépine, Rifampicine, Lansoprazole
- Vaccination during the study
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01874743
Start Date
March 1 2012
End Date
September 1 2013
Last Update
June 12 2013
Active Locations (2)
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1
St Antoine Hospital
Paris, France, 75012
2
HEGP
Paris, France, 75015