HIV infection
Conditions
Interventions
rosuvastatin 20 mg qd, or placebo
Sponsors
Onze Lieve Vrouwe Gasthuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Adults 18 years of age or older. • HIV-1 infection, as documented by a licensed ELISA test kit and confirmed by a Western blot assay • No evidence of acute HIV infection. For the purposes of this study acute HIV infection will be defined as presence of a detectable HIV-1 viral RNA in the presence of a non reactive HIV-1 or HIV-2 antibody assay or an indeterminate western blot. • Treatment naïve, i.e. no current of previous use of HAART • Willingness to use a method of contraception during the study period. Adequate methods of birth control include: condoms, male or female, with or without a spermicide; diaphragm or cervical cap with spermicide; intrauterine device; any of the methods that require a prescription (such as contraceptive pills or patch, Norplant, Depo-Provera, and others) or a male partner who has previously undergone a vasectomy. • Willingness to have blood drawn. • Non known allergy or contraindication to rosuvastatin use. • Ability to understand and willingness to sign the informed consent. • Willingness to have blood stored for future phenotyping and genotyping. • CD4 cell count greater than 350 cells/ml. • Two viral loads that average greater than 1000 copies/ml within a 4 week period. • Liver function tests (AST or ALT) not greater than 1.5 times the upper limit of normal. Evidence of active hepatitis B or C will not be considered an exclusion criterion if the liver function tests are within normal limits. • Creatine phosphokinase elevations (CK) not greater than 3 times the upper limit of normal (ULN) on two sequential determinations and, in the opinion of the investigator, without clear association with exercise. • Laboratory values: Absolute neutrophil count (ANC) greater than or equal to 1000/mm3. Hemoglobin greater than or equal to 7.5 mmol/L Platelet count greater than or equal to 100,000/mm3 Creatinine less than or equal to 2 x ULN. Serum amylase and lipase less than or equal to 1.25 x ULN. • Negative serum pregnancy test at randomization.
Exclusion criteria
Exclusion criteria: • Pregnancy or breast feeding. • Active drug use or alcohol abuse/dependence, which in the opinion of the investigators will interfere with the patient's ability to participate in the study. • Serious illness requiring systemic treatment and/or hospitalization within 30 days of entry. • Evidence of active opportunistic infections or neoplasms that require chemotherapy during the study period • Allergy or hypersensitivity to rosuvastatin or any of its components. • History of myositis or rhabdomyolysis with use of any statins. • History of inflammatory muscle disease such as poly- or dermatomyositis. • Concomitant use of fibric acid derivatives or other lipid lowering agents including statins and ezetimibe. • Concomitant use of drugs that have significant interactions with rosuvastatin. . • Concomitant use of St.Johns wort. • Concomitant use of Valproic acid. • Patients who are on concurrent immunomodulatory agents • Serum LDL cholesterol less than 1.0 mmol/L. • Vaccinations within 6 weeks of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| circulating LPS (LAL assay), TLR mRNA expression in whole blood, circulating IL-6, D-dimer, hsCRP, CD38 and HLA-DR expression on lymphocytes, and microparticles and endogenous thrombin potential as indicators of endothelial damage. | — |
Secondary
| Measure | Time frame |
|---|---|
| HIV viral load, CD4 cell count, total cholesterol and cholesterol subfractions, ApoB/ApoA1 ratio, CK, liver enzymes, renal function, and complete blood count as well as on markers of quality of life measured with the EuroQol-6D questionnaire in treatment-naïve HIV-patients throughout the study period. | — |
Countries
Netherlands
Outcome results
None listed