Lovastatin: Immunomodulatory Value Evaluation

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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 antiretroviral therapy is required.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad de Antioquia
• Collaborators: Humax Pharmaceutical; Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS); Laboratorio Clínico Congregación Mariana; Laboratorios Laproff S.A.
• Treatments: Dihydromevinolin; L 647318; Lovastatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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