HIV-1 infection
Conditions
Interventions
Oral administration of simvastatin (10mg/day) for 8 weeks.
Sponsors
Department of Infectious Diseases, The University or Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Documentation of HIV-1 infection by Western Blot. 2. Absolute CD4+ cell counts have never been below 350 /microL. 3. No history of anti-HIV drug treatment. 4. Age >= 20 years and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. HIV-RNA is not detectable. 2. Acute HIV infection. 3. Use of HMG-CoA reductase inhibitors (includings simvastatin) within 2 months prior to registration. 4. Immunodeficiency disorders (e.g. malignant diseases, chronic granulomatous disease, Wiskott-Aldrich syndrome). 5. Use of systemic corticosteroids, methotrexate and other immunosuppressants. 6. Autoimmune/imflammatory diseases. 7. Pregnat women or women of childbearing potential or brestfeeding 8. Addiction to alcohol or other drugs. 9. Hypothyroidism. 10. Inherited muscle disorders or family history of those disorders. 11. History of drug-induced muscle diseases. 12. Drug allergy to simvastatin or other HMG-CoA reductase inhibitors. 13. Sever liver disordors (Aspartate aminotransferase or Alanine aminotransrerase >= 100 IU/L or total bilirubin >= 2.0 mg/dL). 14. Sever renal disease (Creatinine >= 2.0 mg/dL). 15. Thrombocytopenia(Platelet counts <= 100,000/microL). 16. Total cholesterol <= 150mg/dL or trigryceride <= 50mg/dL. 17. Taking the following drugs: Azole antifungal agents (e.g. itraconazole, miconazole), HMG-CoA reductase inhibitors (excluding simvastatin), Fibric acid derivatives (e.g. bezafibrate), Warfarin, Nicotic acid, Cyclosporine, Macrolides (e.g. erythromycin, clarithromycin), HIV protease inhibitors (e.g. ritonavir) 18. Use of other investigational drugs within 2 months prior to this treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma HIV RNA. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absolute CD4 cell counts. 2. Plasma total cholesterollevels, triglyceride levels and other biochemical tests. | — |
Countries
Japan
Contacts
Public ContactYasuo Ota
The University of Tokyo Hospital Department of Infectious Diseases
Outcome results
None listed