Patients HIV infected
Conditions
Interventions
Product Name: Atorvastatina
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 40-80
Product Name: Simvastatina
Pharmaceutical Form: Table
Sponsors
Fundació Lluita contra la SIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 (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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if treatment with statins (atorvastatina or simvastatina), in the short(4 weeks) term inhibits the viral replication of the VIH after the interruption of the highly active antiretroviral treatment (HAART).;Secondary Objective: To evaluate if treatment with statins (atorvastatina o simvastatina): - maintains the inhibition of HIV viral replication after 12 -24 week of the interruption of HAART treatment - avoids the deterioration of the immunological system in the short and long term despite the interruption of the antiretroviral treatment - diminishes the appearance of an acute retroviral syndrome after the interruption of the antiretroviral treatment. ·To evaluate the security of the therapy with the statins (atorvastatina or simvastatina), during the treatment ·To evaluate if differences regarding the inhibiting effect exist on the viral replication according to the type of estatina or to the dose of atorvastatina ·To evaluate if the basal value of plasmatic cholesterol influences in the inhibition of the viral replication ·To evaluate if the changes in the cholesterol influence in the inhibition of the viral replication ;Primary end point(s): The viral load (the RNA of the VIH) in plasma | — |
Countries
Spain
Outcome results
None listed