Status:
TERMINATED
Influence of Atorvastatin on Viral Replication During Antiretroviral Treatment Interruption
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
To determine the influence of atorvastatin on plasma viral replication when the latter is given before and during highly active anti-retroviral therapy (HAART) in patients with HIV infection and viral...
Detailed Description
Recently, the inhibitory effect of the statins on the replication of the human immunodeficiency virus Type 1 (HIV-1) through two independent mechanisms of action has been described: the blockade of Rh...
Eligibility Criteria
Inclusion
- Age \>= 18 years.
- Patients with chronic infection by HIV-1 in stable highly active antiretroviral treatment (\>= 6 months).
- Undetectable plasma viral load (\<50 copies/mL) in the last 3 determinations over the last 6 months.
- CD4 \> 500 cells/mm\>=3 in the last two determinations.
- Documented prior viral load at some time of \>15,000 copies/mL.
- Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.
- Signature of the informed consent
Exclusion
- CD4 nadir \<= 200 cells/mm3.
- Background of infections or other AIDS-defining pathology.
- Intercurrent infections in the last 6 months.
- Creatine kinase (CK) \>= 500 U/L.
- AST or ALT \>= 3 times higher than the upper limit of normality.
- Treatment with others statins, fibrates, macrolides or fluconazole in the last 3 months.
- Pregnancy or breastfeeding
- Patients participating in another clinical trial
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00355251
Start Date
July 1 2006
End Date
February 1 2007
Last Update
March 20 2014
Active Locations (1)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916