Status:
COMPLETED
Lovastatin: Immunomodulatory Value Evaluation
Lead Sponsor:
Universidad de Antioquia
Collaborating Sponsors:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Laboratorio Clínico Congregación Mariana
Conditions:
HIV Seropositivity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the long-term administration of statins may benefit the clinical and immunological evolution in HIV-1-infected individuals before the use of antiretro...
Detailed Description
Despite the fact that HAART produces a decrease in HIV-1 replication and plasma HIV-1 RNA levels, and allows an increase in the CD4 T-cell count that leads to a diminution in the incidence of opportun...
Eligibility Criteria
Inclusion
- Asymptomatic HIV-1 seropositive individuals, with age ≥ 18 years, who are HAART naive
- HIV-1 infection confirmed by:
- positive Western-blot test dated at least six months before admission to the study;
- a Western-blot test within the last six months, which was also positive for the p31 and p66 bands
- Detectable viral load \< 100,000 copies/ml
- CD4+ T cell count ≥ 350 cells/ul
Exclusion
- Inability or unwillingness of patients to give written informed consent.
- Main residence outside Medellin and its metropolitan area, or any indication of difficulties in the follow-up period
- Participation in other clinical trials
- Evidence that the patient will exhibit low adherence to intervention and follow-up (Morisky-Green test)
- Pregnancy or breastfeeding
- Any type of antiretroviral treatment before admission to the study, and therapy with lipid-lowering drugs during the last six months
- Antecedents of allergy, contraindications or intolerance to statins
- Patients receiving medications which can generate relevant interactions with lovastatin: clarithromycin, erythromycin, azithromycin, itraconazole, ketoconazole, nefodozone, cimetidine, rifampin, phenobarbital, carbamazepine, phenytoin.
- Unwillingness to avoid the consumption of Citrus paradise (grapefruit juice) or Saint John's Wort (Hypericum)
- Opportunistic infections or any type of AIDS-defining disease
- Chronic active hepatitis (B or C)
- Any hepatocellular disease, indicated by elevation of liver enzymes (AST or ALT) more than twice the reference value
- Renal failure, indicated by serum creatinine ≥ 2 mg/dl
- Myopathy, indicated by an elevation of creatine phosphokinase (CPK) more than five times the reference values
- Infection or acute disease that requires in-patient treatment
- Active substance-related disorders
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00721305
Start Date
August 1 2008
End Date
July 1 2011
Last Update
October 4 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Group of Immunovirology, Research Universitary Center, University of Antioquia
Medellín, Antioquia, Colombia