Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT00721305
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00721305
Study Brief:
Protocol Section:
NCT00721305