ESTUDIO DE LA INFLUENCIA DE LAS ESTATINAS EN LA REPLICACIÓN PLASMÁTICA DEL VIH EN PACIENTES CON INFECCION POR EL VIH-1 QUE INTERRUMPEN EL TRATAMIENTO ANTIRRETROVIRA
- Conditions
- Patients HIV infected
- Registration Number
- EUCTR2004-004802-26-ES
- Lead Sponsor
- Fundació Lluita contra la SIDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 41
1.Age ³ 18 years old
2.Patients with HIV-1 chronic infection on highly active antiretroviral treatment including protease inhibitors or Trizivir® (6 months)
3.Plasmatic undetectable viral load (<50 copies/mL) the last two determinations
4.Viral load ³ 15.000 copies/mL.
5.CD4 >500 cells/mm3 the last two determinations
6.Total plasmatic cholesterol between 200 and 250 mg/dL
7.Informed consent signed
8.If female, not to be childbed potential or should use a contraceptive method during the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Antiretroviral treatment that it includes non analogue to nucleosidos (nevirapina or efavirenz)
2.Antecedents of infections or another definitive pathology of AIDS
3.Intercurrent infections in the last 6 months
4.CD4 nadir < 200 cells/mm3.
5.Creatinina >1,5 the superior limit of normality
6.Creatina quinasa (CK) >500.
7.AST o ALT >3 times the superior limit of normality
8.Concomitant treatment with other statins, fibrats, macrolids or fluconazol
9.Pregnancy or breast-feeding
10.Patients who participate on another clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method