Rosuvastatin to Decrease Residual Immune Activation in HIV Infection

NCT01874743 | Unknown Phase 2 DMC

• 1 other identifier: IMEA 043 CESAR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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 20mg/day) for 3 months, on CD8 T cell activation as assessed by the proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR Secondary objectives To evaluate the effect of Rosuvastatin administration on residual CD4 and CD8 T cell activation To evaluate the effect of Rosuvastatin administration on the main serum soluble biomarkers of activation (CRP- HS, D-dimers, IL-6 and soluble CD14) To evaluate the effect of Rosuvastatin administration on CD4 T-cell count and on the CD4/CD8 T-cell ratio To study the relationship between the level of immune activation and the level of residual HIV replication in plasma To study the effect of Rosuvastatin administration on lipid profiles and the correlation between the HDL cholesterol and the CD4/CD8 T-cell ratio To evaluate the tolerance of Rosuvastatin at the dose of 20 mg/day

Conditions

HIV-1 Infection

Keywords

HIV,; Rosuvastatine,; Antiretroviral therapy

Outcome Measures

Primary Outcomes (2)

• CD8 T cell activation

  To evaluate, in HIV-1 infected patients receiving effective antiretroviral therapy, the effect of the addition of Rosuvastatin (dose of 20mg/day) for 3 months, on CD8 T cell activation as assessed by the proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR

  6 months

• Coexpress activation markers

  proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR

  6 months

Secondary Outcomes (5)

• Rosuvastatin administration (on and off)on biomarkers activation

  6 months

• Relationship between the levels of T-cell activation and of plasma HIV-RNA (ultrasensible measure)

  6 months

• CD4 T-cell count and on the CD4/CD8 T-cell ratio

  6 months

• Lipids profiles on and off rosuvastatine association

  6 months

• Tolerance of Rosuvastatine

  6 months

Study Arms (1)

Rosuvastatine 20 mg

EXPERIMENTAL

Rosuvastatin 20 mg/day, once a day during 3 months

Drug: Rosuvastatin 20 mg/day

Interventions

Rosuvastatin 20 mg/day DRUG

All patients must take 20mg/day of rosavastatin during 3 months

Also known as: Crestor ,(ZD 4522)

Rosuvastatine 20 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba: lead
• Sidaction: collaborator

Study Sites (2)

St Antoine Hospital

Paris, 75012, France

RECRUITING

HEGP

Paris, 75015, France

RECRUITING

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Laurence Weiss, PH,MD

  HEGP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence Weiss, PH,MD

CONTACT

56093299; laurence.weiss@egp.aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2012
• First Posted: June 11, 2013
• Study Start: March 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 12, 2013

Record last verified: 2012-12

Locations

FR (2)